PHARMACEUTICAL

INDUSTRIAL TRAINING
REPORT

Submitted by,
Priyanshu kumar
Course-Bachelors in Pharmacy
Year-4th year
Institute – Quantum University
Starting date – 19-06-2023
 An Industrial Training Report
Of
Thrift Pharmaceuticals

A Training Report Submitted to Quantum University, Roorkee

For The Partial Fulfilment of
Bachelor Of Pharmacy
Semester-7th
2023-24

Submitted By:
Name: Priyanshu kumar
Class: B. Pharm. VII Semester
Roll No.: 2006304038

Department of Pharmacy
Quantum School of Health Sciences
Quantum University, Roorkee
2023-24
Training Company
Thrift Pharmaceuticals Pvt. Ltd.
Plant address: Khasra No. 136 Village Raipur, Bhagwanpur, Roorkee-247661
Dist. Haridwar (UK)

Starting Date – 19/06/2023 To 2/08/2023

Managing Director- Manav Singh
Training Certificate
 ACKNOWLEDGEMENT

For my profound success I would like to take this auspicious opportunity to thanks the
management of THRIFT PHARMACEUTICALS PVT.LTD; to Managing Director Mr. Manav Singh
for providing me this opportunity to sharpen my skills by giving me approval to do this
training
I would like to also express my heart felt gratitude towards Mr Sumit Tyagi, Mr Udit, Mr
Pankaj (Q.C personnel), Mr. Sachin (QA Head), and to Mr Shivam (QC Head) THRIFT
PHARMACEUTICALS PVT.LTD. who supervised me during my training period and helped me
to inculcate critical skills in the respected field. I have clean information about every
instrument, testing procedures, laboratory etiquettes and analytical methods. A special
thanks to all staff and workers who cooperate me during the training period.
I would also like to express my gratitude towards Dr. Santosh Kumar Verma (Principal,
Quantum School of health science) , Mrs, Pooja Singh (Associate Professor) and respected
professors who guided me during my training period lending their aid whenever possible.

Sankhadip Panja
Bachelors in Pharmacy 4th year
Quantum School of Health Science.
Quantum University
 Index
S. No. Content
1. Introduction
2. Organization Profile
3. Duration and Scope of Training
4. Training Objectives
5. Technical Details and Learnings
6. Future Prospects
7. Conclusion
8. References
9. Appendices
Introduction

This training report provides a comprehensive overview of the training program completed
in the field of Quality Control (QC) and Quality Assurance (QA) at Thrift Pharmaceuticals
Raipur plant. The training helped in attaining the necessary skills and knowledge required for
ensuring the quality and compliance of pharmaceutical products. The training program
covered a range of topics related to quality control and assurance in the pharmaceutical
industry. It included theoretical knowledge, practical applications, and exposure to industry
best practices.

Primary Objectives in the training regimen:

 Develop an understanding of the regulatory framework governing pharmaceutical
quality control and assurance.
 Gain practical knowledge of analytical techniques used in quality control
laboratories.
 Acquire skills in risk assessment, validation, and documentation in compliance with
industry standards.
 Understand the role of quality assurance in ensuring product quality throughout the
manufacturing process.
 Familiarize oneself with Good Manufacturing Practices (GMP) and Good Laboratory
Practices (GLP).

The training was conducted in fields of:

 Regulatory Compliance: An in-depth study of local and international regulations
governing pharmaceutical quality, including the guidelines provided by regulatory
bodies such as the FDA and WHO.
 Analytical Techniques: Practical training in the use of various analytical instruments
and methodologies employed in pharmaceutical QC, including HPLC, GC,
spectroscopy, and chromatography.
 Quality Assurance Practices: Understanding the role of QA in ensuring compliance,
product quality, and continuous improvement. This included training on risk
management, process validation, and quality management systems.

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Organization Profile:

Thrift Pharmaceuticals is a growing contract manufacturing organization. It is an ISO-GMP

Certified company, THRIFT PHARMACEUTICALS has established itself as a Leading Pharma
Ethical Marketing & Manufacturing Company in providing a wide range of products in the
form of Tablets, Capsules, Syrups, Powders, Sachets, Ointment, IV fluids, Dry injections,
Liquid injections, etc. Guided by the industry's best practices of Medicine Manufacturing, we
operate in a controlled environment to ensure the safest surrounding for the production and
packaging of all products.
To deliver prime quality healthcare products, we strictly follow the international standards
for all processes including both sterile as well as non-sterile processing operations of Pharma
Manufacturers.
Company MISSION
Thrift’s mission is to become the most valued Pharma Company by continuously researching,
developing and manufacturing a wide range of pharmaceutical products that comply with the
highest regulatory standards and to serve the nation.

Company VISION
The vision is to focus on expansion on national & global platform along with value addition
and commitment to healthcare and life.
join your hands with the most promising Indian Pharma Franchise company.

Facilities of Thrift Pharmaceuticals:

 It has a sophisticated manufacturing unit which is ISO, GMP and FDA approved
company whose production is divided into 3 units employed in production of more
than 450 pharmaceutical products.
 It involves more than 60 expert highly trained managerial staff involved in proper
quality control and quality assurance
 It has over 25 years of experience in the pharmaceutical industrial field and has a
highly content customer population

Sister and Parent Company:

 Thrift Enterprises inc.

 Canvendish Bio Pharma Pvt. Ltd.
 Valto Pharmaceuticals
 Titlis Pharmaceuticals

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Duration and scope of training:

The industrial training in the Raipur plant of Thrift Pharmaceuticals lasted for a period of 45
days.
During this period, we had a vast number of duties that were included in the training regimen
in the quality control department of the industry.
Some of such duties included:
 Ensuring proper cleanliness in the laboratory
 Collect the samples from raw material store following proper procedures
that are in the quarantine area and either approving or rejecting the raw
materials after proper testing.
 Collecting the bulk preparations from the production unit and checking
for their potency to ensuring them for final production
 Checking the potency for final product ensuring it quality before it went
to the distributors
 Checking the calibration on each instrument, and recalibrate before their
next calibration date.
 Check for the quality of water that was used in quality control and
production plant.
 Check for microbial growth within the clean rooms, laboratories and
production plants.
 Filling of documents associated with all the testing of the
pharmaceutical’s products.

Training Objectives:

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There is certain skill set that were acquired during the training regimen in the quality control
department. Some of them are:
 Proper gowning and steps required during the working hours in the Laboratory
 Proper sampling procedures of Raw, bulk, semi-finished and finished products.
 Performing Quality Control tests for solid tablets, capsules, liquid orals.
 Proper report fillings of the findings under guidance
 Calibration of UV Spectrophotometer, PH meter, Weight Scale.
 Acquiring proper knowledge about instruments present in QC lab along with their
uses and maintenance.

Quality Control is concerned with sampling, specifications and testing as well as the
organisation, documentation and release procedures which ensure that the necessary and
relevant tests are carried out, and that materials are not released for use, nor products
released for sale or supply, until their quality has been judged satisfactory. Quality Control is

4
not confined to laboratory operations, but must be involved in all decisions which may
concern the quality of the product. The independence of Quality Control from Production is
considered fundamental to the satisfactory operation of Quality Control.

Proper techniques to follow in Quality Control lab:

Proper laboratory practices, starting from gowning, are crucial in maintaining aseptic
conditions, preventing contamination, and ensuring the integrity of pharmaceutical testing
and manufacturing processes. Some of the steps from gowning to maintaining a good
laboratory practices in a pharmaceutical company are:

Proper Gowning
Cleanroom Garments: Wear appropriate cleanroom garments, including gowns,
gloves, head covers, masks, and shoe covers. Ensure that garments are made of
suitable materials that minimize particle shedding. Ensure that only clean garments
are worn, in order to prevent contamination. Ensure that proper gowning is done
before entering each level of clean rooms.
Personal Hygiene: Shower and thoroughly wash hands and forearms before entering
the cleanroom. Avoid wearing makeup, jewellery, or other accessories that could
introduce contaminants. Avoid usage of any kind of addictive substances into the
premise. Report to the medical department if there are any open wounds.
Gowning Sequence: Follow a specific gowning sequence to minimize the risk of
contamination. Ensure that the gowning procedure is clearly documented in standard
operating procedures (SOPs).

Laboratory Practices:
Entry and Exit Protocols:
ENTRY IN QUALITY CONTROL DEPARTMENT:

Collect the set of uniform from respective change room. Enter in the respective change
room (Gents will enter through gents change room and Ladies will enter through ladies
change room). Follow the gowning procedure. Staff will wear white apron, while workers will
follow dress code of secondary packing worker. Remove the street footwear, keep in the rack
provided and wear the laboratory footwear. Enter to wide corridor leading to main QC door.
Enter at the main QC door and proceed to respective rooms / section.
EXIT FROM QUALITY CONTROL DEPARTMENT :

Exit the respective rooms / sections and come to the wide QC corridor. Enter in to the wide
corridor. Enter in respective change room (Gents will enter to gents change room and Ladies
will enter to ladies change room). Remove the laboratory footwear in the rack provided. Exit
from the respective change room by following the procedure for degowning. Keep the set of
factory uniforms in the individual lockers or put in the container for Washing purpose.

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 Equipment Preparation: Clean and sanitize equipment before and after use. Follow
proper procedures according to the SOP. Check for calibration, if found faulty inform
the nearest supervisor.
Safety Measures: Follow safety guidelines, including the proper use of personal
protective equipment (PPE). Conduct risk assessments for hazardous materials and
procedures.

Testing Procedures:
Material Handling: Implement proper procedures for receiving, handling, and storing
materials to prevent contamination. Use dedicated tools and equipment for different
materials.
Sampling Procedures: Follow established sampling protocols for raw materials and
in-process samples. Use appropriate sampling techniques to ensure representative
samples. Clean the equipment with isopropyl alcohol every time after sampling to
prevent cross contamination.
Testing Protocols: Adhere to standardized testing procedures outlined in SOPs.
Perform tests using validated methods and equipment.
Documentation: Document all activities, including sample preparation, testing, and
observations. Record data in real-time and follow good documentation practices
(GDP).
Documentation includes: Standard Operating Procedures (SOPs): Creation and
Revision: SOPs describe the step-by-step procedures for various quality control
activities. These include testing methodologies, equipment operation, and data
review.
Approval and Training: SOPs require approval by authorized personnel, and
personnel involved in QC activities must be trained on these procedures.

Test Methods and Specifications:

 Test Methods: Documented procedures for conducting various tests,
including analytical methods, physical testing, and microbiological assays.
 Specifications: Documented criteria that a product or material must meet,
including acceptance criteria for quality attributes.
Instrument Calibration and Maintenance Records:

 Calibration SOPs: Procedures for calibrating instruments used in QC.

 Calibration Records: Documentation of instrument calibration, including
dates, results, and any adjustments made.
 Maintenance Records: Documentation of routine maintenance activities for
instruments.
Validation and Qualification Protocols and Reports:

 Validation Plans: Outlining the strategy for validating analytical methods,

equipment, and processes.

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  Qualification Protocols and Reports: Documenting the qualification of
equipment and systems used in QC.
Raw Material, In-Process, and Finished Product Testing Records:

 Testing Protocols: Documenting the procedures for testing raw materials, in-
process samples, and finished products.
 Test Records: Recording actual testing results, including observations and any
deviations from expected outcomes.
Stability Study Protocols and Reports:

 Stability Study Protocols: Outlining the procedures for conducting stability

studies.
 Stability Study Reports: Documenting the results and conclusions of stability
studies.
Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigations:

 Investigation Protocols: Describing the procedures for investigating OOS and

OOT results.
 Investigation Reports: Documenting the findings of investigations, including
root cause analysis and corrective actions.
Change Control Records:

 Change Requests: Documenting proposed changes to procedures, methods,

or equipment.
 Change Control Records: Recording the approval and implementation of
changes.
Training Records:

 Training Plans: Outlining the training requirements for QC personnel.

 Training Records: Documenting training activities, including dates and topics
covered.
Data Integrity and Good Documentation Practices (GDP):

 Data Integrity Policies: Establishing policies to ensure the integrity of data

generated during QC activities.
 GDP Guidelines: Documenting guidelines for good documentation practices,
including the use of logbooks, notebooks, and electronic records.

Quality Control Batch Release Records:

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  Release Criteria: Specifying the criteria for releasing batches of finished
products.
 Batch Release Records: Documenting the decision-making process for
releasing batches.

Miscellaneous Responsibilities
Waste Management:
SOLIDS
RAW MATERIALS

 Empty the content after analysis in a waste bin containing water to make slurry.
 Dispose off the slurry in sink with continuous flow of water.
 Maintain Batch wise destruction record with signature of chemist in Raw Material
Register.
INPROCESSPRODUCTS

 Empty the content after analysis in a waste bin containing water to make slurry.
 Dispose off the slurry in sink with continuous flow of water.
 Maintain Batch wise destruction record with signature of chemist in IN process
Product Register.
FINISHED PRODUCTS

 Take out tablets/ capsules from blister / strip / bulk container and Empty the content
in to waste bin containing water to make slurry.
 Dispose off the slurry in sink with continuous flow of water.
 Destroy the carton/catch cover by cutting.
 Maintain Batch wise destruction record with signature of chemist in Finished Product
Register.
PACKAGING MATERIALS

 Packaging materials like Poly bags, Paper etc. are disposed in the scrap yard after
shredding or defacing.
 Destroy the cartons/catch cover/leaflet/foil by cutting.
 Maintain material wise destruction record with signature of chemist in Packaging
Material Register.
LIQUIDS

 Neutralise waste liquids like Acids, alkali, Solutions, slurry, KF titration waste
etc. separately and then dispose off in the sink with continuous flow of water.
 Use hand gloves, safety goggles and mask while disposal of hazardous chemicals.

Record Retention and Archiving:

Laboratory documentation should follow the principles. An important part of this
documentation deals with Quality Control and the following details should be readily

8
 available to the Quality Control Department: specifications; procedures describing
sampling, testing, records (including test worksheets and/or laboratory notebooks),
recording and verifying; a procedure for the investigation of Out Of Specification and
anomalous results and Out Of Trend results; procedures for and records of the
calibration/qualification of instruments and maintenance of equipment; testing reports
and/or certificates of analysis; data from environmental (air, water and others utilities)
monitoring, where required; validation records of test methods, where applicable

Any Quality Control documentation relating to a batch record should be retained on

retention of batch documentation. Some kinds of data (e.g., tests results, yields,
environmental controls) should be recorded in a manner permitting trend evaluation.
Any out of trend or out of specification data should be addressed and subject to
investigation. In addition to the information which is part of the batch documentation,
other raw data such as laboratory notebooks and/or records should be retained and
readily available

Quality Control Checks: Implement internal quality control checks to monitor the
precision and accuracy of testing methods. Participate in proficiency testing programs to
assess external quality control.
Testing and release of In-process samples, semi-finished products and finished products.

Sampling of in-process samples, semi-finished products and finished products (Packed

product) shall be conducted by IPQA person after completion of activity. (Sampling of
Intermediate and Finished Product SOP)

 Test order shall be created in system by production chemist.

 IPQA chemist shall collect the samples and product intimation slip (test request) with
sign of production chemist.
 IPQA chemist shall submit the sample along with the test request to finished product
section head.
 Test order number shall be mentioned on test request. The same test order number
shall be considered as certificate number of the product.

Testing of in-process samples and semi-finished products:

 Finished product section head shall enter details of product in finished product entry
log book.
 Test data sheet of in-process testing and finished product shall be issued by the
document cell of QC department.
 Finished product section head shall assign chemist and microbiologist for analysis.
 The sample shall be hand overed to assigned chemist / microbiologist with test order
and test data sheet.
 Meanwhile, test order shall be released in system.
 The status of test order shall be shown as “Value recording”.

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  Chemical and instrument analysis shall be conducted in the quality control
department in respective section. Microbiological analysis shall be conducted in the
microbiology lab.

Release of in-process samples and semi-finished products:

 After completion of the total analysis, Quality control chemist shall report to finished
product section head with filled test data sheet.
 Finished product section head shall review the complete document.
 Value recording of test order of product shall be carried out by the analyst in ERP
system.
 After completion of value recording, the status of the same test order shall be shown
as “Testing finished”.
 Finished product section head shall verify the COA in system against the raw data and
ensure that Inspection results shall be shown as “Items are ok”.
 The test order shall be finished by the finished product section head.
 The status of test order shall be shown as “Finished”.
 The reviewed documents along with analytical raw data shall be submitted to
Manager – QC for approval.
 Manager – QC shall review the documents and approve by taking test decision in
system.
 Certificate of Analysis (COA) will be taken from ERP system as Electronic Signature.
(Without having manual signature).
 Certificate of Analysis and Release Slip shall be taken by ERP system.
 The approved document of semi-finished product and in-process testing sample with
complied raw data shall be submitted to concerned Quality Assurance officer.
 Concerned Quality Assurance officer shall review the documents.
 Semi-finished product shall be released based on the release limits (with stringent
limit).
 All injectable shall be released after completion of sterility test (14 days) along with
other test.
 All tablets and capsules shall be released after completion of microbial test (5 days.)
along with other test.

Testing and release by Single Pharmacopeia as per requirement:

 Semi-finished product shall be tested as per the approved specification.
 The analysis of the batch of the product by single pharmacopeia shall be decided by
the production planning team.
 Request for analysis by single pharmacopeia if required shall be sent QA by
production planning team as per format of Declaration for batch analysis
requirement, Annexure No.: 07
 The same declaration form shall be approved by Head-QA or his/her designee.

10
  The approved declaration form shall be issued to production department with Batch
manufacturing record at the time of issuance by QA.
 The same declaration form shall be handed over to QA with ERP created test request
of the same batch by production department.
 The test property set of respective tests which are not required to analyze as per
declaration form will be deleting by an authorized QA person.
 The modification by deleting test property set shall be done in test order level only.
 The declaration form and ERP created test request with sample will be submitted to
QC by QA.

Testing and release of finished product (Packed product):

 After receiving the packed product with test request and sample, finished product
section head shall enter details of product in finished product entry log book.
 Finished product section head shall assign chemist for analysis.
 The sample shall be tested for identification or other test such as pH, water content,
Average weight etc. as per specification.
 After completion of value recording, the status of the same test order shall be shown
as “Testing finished”.
 Finished product section head shall verify the COA in system against the raw data and
ensure that Inspection results shall be shown as “Items are ok”.
 The test order shall be finished by the finished product section head.
 The status of test order shall be shown as “Finished”.
 The reviewed document along with analytical raw data will be submitted to Quality
Assurance Manager or his designee for approval.
 Manager – QA or his designee shall review the documents and approve by taking test
decision in system.
 Certificate of Analysis (COA) will be taken from ERP system as Electronic Signature.
(Without having manual signature).
 Certificate of Analysis and Release Slip shall be taken by ERP system.
 Finished product (Packed product) shall be released based on the shelf life limit.
 The test order shall be released, value recording, testing finished and approved in
ERP system.

Handling of remain sample after testing:

 The remaining in-process samples, semi-finished products & finished product have to
be disposed of after testing.
 Dispose of should be done under supervision of responsible person
 This procedure is written as a policy to be strictly followed.
 Samples that may be left after analysis:
 Finished products – Injectable preparation – Cytostatic and general
 Finished products – Tablet/Capsule – Cytostatic.

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 In-process sample (Semi finished product) – Injectable preparation – Cytostatic and
general.
 In-process sample (Semi finished product) – Tablet/Capsule – Cytostatic.
 In-process samples/Finished product – Injectable preparation – cytostatic product:
 In-process samples/finished packs excess left after testing to be disposed of as:
 For ampoules: Break the ampoule and the content is drained into bucket/bin. Empty
ampoules are kept in other bucket/bin containing 4-6 % sodium hypochlorite
solution.
 For vials (liquid): Open the Vial using de-sealer and the content is drained into
bucket/bin. Empty vials and plugs are kept in other bucket/bin containing 4-6 %
sodium hypochlorite solution.
 For vials (dry powder): Open the Vial using de-sealer and the powder is added to
water in bucket/bin. Empty vials and plugs are kept in other bucket/bin containing 4-
6 % sodium hypochlorite solution.
 Empty vials/ampoules are kept with 4-6 % sodium hypochlorite solution for half an
hour for deactivation of cytostatic product.
 Wash the vials/ampoules with water and dispose of by breaking manually or using
ampoules crushing machine in small pieces.
 Add sufficient quantity of 4-6 % sodium hypochlorite solution to the content
collected for deactivation of cytostatic product. Mix and keep it for 30 minutes.
 After 30 minutes, the solution is diluted out with water and hand over to EHS
department for discarding.
 In-process samples/Finished product – Tablet/Capsule – Cytostatic product:
 In-process samples/finished packs excess left after testing to be disposed off as:
 In-process samples/finished packs excess left after testing are transferred into a
bucket/bin containing water, stir vigorously.
 Add sufficient quantity of 4-6 % sodium hypochlorite solution to the content
collected for deactivation of cytostatic product. Mix and keep it for 30 minutes.
 After 30 minutes, the solution is diluted out with water and hand over to EHS
department for discarding.
 Empty bags/containers are kept into bucket/bin containing 4-6 % sodium
hypochlorite solution. Dip bags/containers completely and allow to deactivate for
about 30 minutes. Drain the solution into another bin. Wash bags/containers with
water. Washed bags/containers are disposed off in a manner prescribed by local
council.
 In-process samples/Finished product – Injectable preparation – General:
 In-process samples/finished packs excess left after testing to be disposed off as:
 For ampoules: Break the ampoule and the content is drained into bucket/bin.
 For vials (liquid): Open the Vial using de-sealer and the content is drained into
bucket/bin.
 For vials (dry powder): Open the Vial using de-sealer and the powder is added to
water in bucket/bin.

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  Vials/ampoules are disposed off by breaking manually or using ampoules crushing
machine in small pieces.
 The content is diluted out with water, drain it and then flush with excess of water.

Handling and analysis of Rinse samples (Residual samples):

 Rinse samples will be collected after cleaning of the equipment which were used for
manufacturing of the products.
 Rinse sample request shall be created by IPQA.
 IPQA chemist shall submit the rinse samples to QC department.
 Section head shall verify the rinse samples against intimation slip of rinse sample
analysis and hand over the samples to the analyst for analysis.
 Analyst shall verify the samples against intimation slip of rinse sample analysis and
analyse by using UV spectrophotometer.
 Rinse samples will be examined in the range of 200 nm to 400 nm in UV
spectrophotometer.
 The absorbance shall be compared with blank absorbance in the same range.
 Water will be examined in the range of 200nm to 400nm as a blank run.
 The absorbance of the rinse samples should be equivalent with absorbance blank.
 If rinse samples chromatograms will be complied the acceptance criteria, QC analyst
shall update comply remarks and request send for approval to authorized QC senior
person.

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  The authorized QC senior person shall verify and the same intimation of rinse sample
analysis shall be approved.

Example of document required to

be filled:

Quality Control Test for tablets:

Non-Pharmacopeial or Non-Official Tests or In-House Tests
The choice of these tests and their specification depend on the formulator during drug
product development and these tests are not restricted or specified in any pharmacopoeia.

Appearance/ Description
The appearance of a tablet is crucial for patient compliance and identification. The control of
the appearance of a tablet includes the measurement of a number of attributes such as a
tablet’s shape, surface texture, diameter, thickness, colour, absence or presence of an odour,
taste, physical flaws and consistency, scoreline, and legibility of any unique identification
markings such as embossed or engraved with a logo or letter(s).

Unique Identification Markings

Pharmaceutical companies often use some type of unique markings such as embossed or
engraved with a symbol or letters or printing on the tablet for rapid identification. The
tablets may score in halves or quadrants to facilitate breaking or to make the smaller dose.
Intact and clear unique identification markings on tablets are acceptable.

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Thickness of tablets
The thickness of the tablet is the only dimensional variable related to the tablet compression
process. Generally, it is measured with a micrometre. The thickness should control within
±5% variation of a standard value and must control for patient acceptance and make the
tablet packaging easier.

Diameter and Shape of Tablets

The diameter and shape of the tablets should control by the diameter and shape of the die
and punches during the compression process. USFDA recommends that the diameter of the
tablet should be 8 mm or less than 8 mm and should not exceed 22 mm. Generally, tablet
shapes are round, oval, oblong, caplet, cylindrical, triangular etc. The upper and lower
surfaces of tablets may be flat, round, concave, or convex to various degrees. The diameter
and shape of the tablet influence oesophageal transit, administration techniques (i.e., use of
fluids, patient position), and irrespective of patient factors.

Organoleptic properties (color, odor, and taste)

 Color: Tablet color is crucial for identification and patient acceptance.
 Odor: Some types of tablets such as ODT tablets, and chewable tablets have an odor
to make a pleasant taste and improve patient acceptance. Besides in some tablets,
flavouring agents are used within coating material to mask bad odor.
 Taste: Taste is important for patient acceptance, especially for ODT tablets, chewable
tablets, and dispersible tablets.

Tablet breaking force/Hardness of Tablets

The breaking force of tablets is commonly called “hardness” in the pharmaceutical
literature; however, the use of this term is misleading according to USP. Certainly, tablets
require a definite amount of hardness to withstand mechanical shocks of handling in
manufacture, packaging, and transportation without affecting the disintegration limit.
Generally, oral tablets have a hardness of 4 to 10 kg. However, ODT tablets and chewable
tablets have less hardness and often sustained-release tablets are much harder. The units of
measurement of tablet hardness are Kilogram (kg), Newton (N), Pound (lb), and Strong-Cobb
(SC).

Pharmacopeial or Official Tests for the Evaluation of tablets

These tests are specified either in individual product monographs or general monographs.

Identification Tests of Tablets

The identification test is specified in a product monograph as an aid to confirm that the
tablet contains the labelled drug substance by providing positive identification of the active
substance(s) and identification of specific excipient(s), such as preservatives in a drug
product. Generally, one method of confirming the identity is to compare the retention time
of the sample with that obtained for the standard injections in a chromatographic assay

15
procedure by HPLC. Other methods also used to orthogonally confirm the identity of the
active ingredient are: Thin-Layer Chromatographic Identification Tests, Spectroscopic
Identification Tests, Nuclear Magnetic Resonance Spectroscopy, Near-Infrared Spectroscopy
as well as Raman Spectroscopy among others. It is a pharmacopeial test for the evaluation of
tablets or quality control tests of tablets.

Friability test of uncoated tablets

Friability testing is used to test the durability of tablets during transit (packing,
transportation). Measurement of tablet friability supplements other physical strength
measurements, such as tablet breaking force. It is a pharmacopeial test for the evaluation of
tablets or quality control tests of tablets.

Friability test formula

For ≤ 650 mg weight of tablets, take 6.5 g tablets or as near as possible to 6.5 g. For tablets
with more than 650 mg weight, take 10 tablets. The tablets must be carefully dedusted prior
to testing.

Friability test limit: A maximum weight loss (obtained from a single test or from the
mean of three tests) of not more than 1.0% is considered acceptable. Moreover,
effervescent tablets and chewable tablets may have different specifications as far as friability
is concerned.

Disintegration Time Test

Disintegration is the process by which a solid oral dosage form such as a tablet breaks down
into smaller particles or granules. The tablets must disintegrate and all particles must pass
through the 10-mesh screen in the time specified. Complete disintegration is that state in
which any residue of the unit (tablet or capsule or granules) except fragments of insoluble
coating or capsule shell, remaining on the screen of the disintegration apparatus or adhering
to the lower surface of the disk if used, is a soft mass having no palpably firm core.
Disintegration is provided to determine whether tablets, capsules, or granules disintegrate
within the prescribed time when placed in a suitable liquid medium in a 1000 ml beaker at
37°C ± 2°C. It is a pharmacopoeial test for the evaluation of tablets or quality control tests of
tablets.

16
 Immersion Fluid/ Temp. Limit
Types of Tablet
Medium
*Uncoated or Plain- Water or 37 ± 2°C As specified in the
coated tablets specified medium individual product
as the immersion monograph.
fluid.
Delayed-Release 0.1 M 37 ± 2°C After 1 hour no
Tablets or Acid- Hydrochloric acid, evidence of
Resistant or Enteric- or Simulated disintegration,
Coated Tablet Gastric Fluid as cracking or
specified in the softening.
monograph.
pH 6.8 phosphate 37 ± 2°C As specified in 5 mins or as
buffer, or Simulated the individual specified in the
Intestinal Fluid as product individual product
specified in the monograph. monograph.
product
monograph.
Effervescent Tablets 200 ml of water 37 ± 2°C 5 mins or as
in 250–400 ml specified in the
beaker. individual product
monograph.
Effervescent Place 1 dose in 37 ± 2°C 5 mins or as
Granules 200 ml of water specified in the
in 250–400 ml individual product
beaker. monograph.
Buccal, Sublingual Water or 37 ± 2°C As specified in the
Tablets, Orally specified medium individual product
Disintegrating as the immersion monograph.
Tablets, Chewable fluid.
Tablets
Tablets for Oral Water or 37 ± 2°C As specified in the
Suspension or Oral specified medium individual product
Solution or Topical as the immersion monograph.
solution fluid.

17
Uniformity of Weight (Mass) of Tablet
A weight variation test is performed to determine the consistency of formulated
preparations. It is a pharmacopoeial test for the evaluation of tablets or quality control tests
of tablets. According to USP, BP & IP the accepted limit of weight variation is given below:

Average Mass
IP/BP USP
Limit

Tablet weight 130 mg

Tablet weight 80 mg or less ± 10%
or less

More than 80 mg or Less than

± 7.5% 130 mg to 324 mg
250mg

250 mg or more ± 5% More than 324 mg

Uniformity of Dosage Unit test for the Evaluation of tablets

The term “uniformity of dosage unit” is defined as the degree of uniformity in the amount of
the drug substance among dosage units. To ensure the consistency of dosage units, each
unit in a batch should have a drug content within a narrow range around the label claim. It is
a pharmacopoeial test for the evaluation of tablets or quality control tests of tablets.
The uniformity of dosage units can be demonstrated by either of two methods, Content
Uniformity or Weight Variation. The test for Content Uniformity of preparations presented in
dosage units is based on the assay of the individual content of drug substance(s) in a
number of dosage units to determine whether the individual content is within the limits set.

18
Dissolution test of Tablets
Dissolution is the process in which a substance forms a solution. In vitro, dissolution testing
measures the extent and rate of solution formation from a dosage form (the amount of
percentage of the drug substance in a dosage form such as tablets, or capsules to go into
solution) within a specific time under a specified set of conditions. The terms dissolution and
drug release are used interchangeably. The USP dissolution test in the monograph is related
to Bioavailability and Bioequivalence study only when closely allied with a sound regulatory
determination. Without this association, the dissolution test should be regarded solely as a
quality control test for batch release [4]. It is a crucial pharmacopoeial test for the evaluation
of tablets or quality control tests of tablets.

The volume of the dissolution medium is generally 500, 900, or 1000 ml. The use of a hydro-
alcoholic medium is discouraged. Certainly, conduct all dissolution tests for IR dosage forms
at 37±0.5°C.
Before the dissolution test you have to consider the following information:
 Apparatus
 Speed (RPMs)
 Medium Volume (mL)
 Recommended Sampling Times (minutes)

Types of Dissolution Apparatus

Types of
General Critical test
Dissolution Dosage form to be tested
Name parameters
Apparatus

Conventional/Immediate-Release,
Apparatus- Basket Rotation
Prolonged/Extended-Release,
1 Apparatus Speed
Delayed-Release Dosage Forms

Conventional/Immediate-Release,
Apparatus- Paddle Rotation
Prolonged/Extended-Release,
2 Apparatus Speed
Delayed-Release Dosage Forms

Apparatus- Reciprocating Conventional/Immediate-Release,

Dip Rate
3 Cylinder Prolonged/Extended-Release,

19
 Apparatus- Flow- Flow Rate Conventional/Immediate-Release,
4 Through Cell Of Medium Prolonged/Extended-Release,

The United States pharmacopeia and British pharmacopoeia recommend four

types of dissolution apparatus for Test for Solid Dosage Forms:
The acceptable limit of Dissolution
Generally, Not less than 75% (Q) of the labelled amount of the drug is dissolved in 45
minutes or specified in individual product monographs.
For rapidly dissolving products, the generation of an adequate profile sampling at 5- or 10-
minute intervals may be necessary. For highly soluble and rapidly dissolving drug products
(BCS classes 1 and 3), a single-point dissolution test specification of NLT 85% (Q=80%) in 60
minutes or less is sufficient as a routine quality control test for batch-to-batch uniformity. On
the other hand, for slowly dissolving or poorly water-soluble drugs (BCS class 2), a two-point
dissolution specification, one at 15 minutes to include a dissolution range (a dissolution
window) and the other at a later point (30, 45, or 60 minutes) to ensure 85% dissolution, is
recommended to characterize the quality of the product.
Dissolution testing and interpretation can be continued through three stages if necessary. In
stage 1(S1), six tablets are tested and are acceptable if all of the tablets are not less than the
monograph tolerance limit (Q) plus 5%. If the tablets fail S1, an additional six tablets are
tested (S2). The tablets are acceptable if the average of the twelve tablets is greater than or
equal to Q and no unit is less than Q minus 15%. If the tablets still fail the test, an additional
12 tablets are tested. The tablets are acceptable if the average of all 24 tablets is greater
than or equal to Q and if not more than 2 tablets are less than Q minus 15%.

20
Quality Control tests for Liquid Orals
Evaluation of Syrups:

A concentrated solution of a sugar, such as sucrose, in water or other aqueous

liquid, sometimes with a medicinal agent added; usually used as a flavoured vehicle
for drugs. It is commonly expanded to include any liquid dosage form (e.g., oral
suspension) in a sweet and viscid vehicle.

Following tests are carried out for the evaluation of syrups:

(a) Transmittance of light: A light transmittance meter is a newer tool that is

used to check syrup color. In a light transmittance meter, a syrup sample is checked
for color by passing light through the sample. The percent of light transmission is
compared to light transmission rates set for different grades. When using one, you need to
be sure there are no fingerprints on the syrup test bottle, and that the syrup sample has no
bubbles or cloudiness. Any of these conditions may diminish the light that is transmitted
through the sample and therefore lowers the grade of the sample.

(b) Visual inspection: With a visual inspection, the ingredients and the final
products are carefully examined for purity and appearance. The physical appearance
of products for patient adherence and compliance is critical so it should be

 Good looking
 Elegance in appearance
(c) pH measurement: The measurement and maintenance of pH is also a very
important step in quality control testing. Generally, there are two different types of
methods used in the measurement of pH.

Methods for pH measurement:

 The simplest and cheapest is to dip a piece of pH paper into the

sample. The paper is impregnated with chemicals that change color
and the color may be compared to a chart supplied with the paper to
give the pH of the sample.
 If the greatest accuracy is required a pH meter should be used. A
typical pH meter consists of a special measuring glass electrode
connected to an electronic meter that measures and displays the pH
reading.
(d) Sucrose concentration: The determination of sucrose concentrations is
also very important in quality control testing of syrups. If the concentration of sucrose
in the syrup is very high it may crystallize the syrup and fewer sucrose
concentrations give favour for the microbial growth.

(e) Physical stability in syrups: The syrups must be stable physically.

Example:

21
  Its appearance (no crystallization and microbial growth)
 Colour must be completely soluble with other ingredients
 Odor and taste(palatable).
 The solid material is completely miscible in liquid

Evaluation of Liquid Orals

Definition: Elixirs are clear, sweetened hydro-alcoholic solutions intended for oral
use and are usually flavored to enhance their palatability.

Evaluation Parameters:

(a) Determination of alcohol content: Elixir usually contains 5 to 40%

alcohol. The determination of alcohol unless otherwise specified in the individual
monograph. It is suitable for examining most fluid extracts, tinctures and elixirs
provided the capacity of the distilling flask is sufficient (commonly two to four times
the volume of the liquid to be heated) and the rate of distillation is such that clear
distillates are produced. Cloudy distillates may be clarified by agitation with talc, or
with calcium carbonate. And filtration is done. After which the temperature of the
filtrate is adjusted and the alcohol content determined from the specific gravity.
During all manipulations, take precautions to minimize the loss of alcohol by
evaporation. For liquids, it is presumed to contain less than 30% of alcohol.

(b) Viscosity measurement: Viscosity is a property of liquids that is directly

related to the resistance to flow. Viscosity measurement is a very important quality
control test in the case of syrups and elixirs. Viscosity and consistency directly relate
to the stability of solutions. If viscosity increases, then there is a chance of increased
instability.

Test for Pharmaceutical Suspensions:

A pharmaceutical suspension is a coarse dispersion in which insoluble particles,

generally greater than 1 µm in diameter, are dispersed in a liquid medium, usually
aqueous.

Following tests are carried out for the evaluation of suspensions:

(a) Sedimentation method: Two parameters are studied for the determination
of sedimentation. They are (i) Sedimentation volume and (ii) Degree of flocculation.

(i) Sedimentation Volume: The suspension formulation (50 ml) is poured

separately into 100 ml measuring cylinders and sedimentation volume is read after 1,
2, 3, and 7 days, and thereafter at weekly intervals for 12 weeks. Triplicate results

22
are obtained for each formulation. Sedimentation volume is calculated according to
the equation:

(ii) Degree of flocculation (β): It is the ratio of the sedimentation volume of the
flocculated suspension (F), to the sedimentation volume of the deflocculated
suspension, (F∞).

(b) Rheological method: Viscosity of suspensions is of great importance for

stability and pourability of suspensions. As we know suspensions have the least
physical stability amongst all dosage forms due to sedimentation and cake formation.
So as the viscosity of the dispersion medium increases, the terminal settling velocity
decreases thus the dispersed phase settle at a slower rate and they remain
dispersed for a longer time yielding higher stability to the suspension. On the other
hand, as the viscosity of the suspension increases, its pourability decreases, and
inconvenience to the patients for dosing increases. Thus, the viscosity of suspension
should be maintained within the optimum range to yield stable and easily pourable
suspensions.

 A practical theological method involves the use of a Brookfield

viscometer mounted on a helipad stand. The T-bar spindle is made to
descend slowly into the suspension, and the dial reading on the
viscometer is then a measure of the resistance the spindle meets at
various levels in sediment.
 Data obtained on samples variously aged and stored indicate whether
undesired changes are taking place. This measurement is made on
undisturbed samples of different ages. The results indicate how the
particles are settling with time.

23
  In the screening study, the better suspensions show a lesser rate of
dial reading with spindle turns, i.e., the curve is horizontal for a longer
period.

(c) Electrokinetic method: In this zeta potential is measured by using micro

electrophoresis apparatus and zeta plus (Brookhaven instruments corporation,
USA). It shows the stability of a dispersed system.

Zeta potential: The zeta potential of the formulated suspensions is determined

using a zeta plus (Brookhaven instruments corporation, USA). Approximately 1 ml of
suspension is transferred into a plastic cuvette using a pipette and diluted with
distilled water. The Brookhaven zeta potential software is used for the measurement.
Parameters set to a temperature of 25o C and refractive index (1.33). The zeta
potential of the formulations is determined on days 0, 7, 14, 21, and day 28 post
formulation.

(d) Micromeritic method: The stability of suspension depends on the particle

size of the dispersed phase. Change in the particle size concerning time will provide
useful information regarding the stability of a suspension. A change in particle size
distribution and crystal habit can be studied by microscopy and the Coulter counter
method.

Photomicroscope method: The microscope can be used to estimate and

detect changes in particle size distribution and crystal form. Rapid processing of
photomicrographs is enhanced by attaching a Polaroid camera to the piece of the
monomolecular microscope. By using these photomicrographs, we can determine
the changes in physical properties and stability of suspensions.

(e) Freeze-thaw test: Freeze-thaw test conducted by placing the sample in a

freezer for 18 hours followed by thawing at room temperature for 4 to 6 hours.
Repeat the freeze-thaw cycle 10 times. This test is conducted to determine the
tendency to crystallize or color.

(f) pH measurement: The measurement and maintenance of pH is also a very

important step in quality control testing. Generally, there are two different types of
methods used in the measurement of pH.

Methods for pH measurement: The simplest and cheapest is to dip a piece of

pH paper into the sample.

(g) Visual inspection: With a visual inspection, the ingredients and the final
products are carefully examined for purity and appearance. The physical appearance
of products for patient adherence and compliance is critical so it should be good
looking and elegant in appearance.

24
Evaluation of Emulsions:
An emulsion is a system consisting of two immiscible liquid phases, one of which is
dispersed throughout the other in the form of fine droplets. A third component, the
emulsifying agent, is necessary to stabilize the emulsion.
Following are tests carried out for evaluation of emulsions:
(a) Determination of particle size and particle count: Determination of
changes in the average particle size or the size distribution of droplets is an
important parameter used for the evaluation of emulsions. It is performed by optical
microscopy, sedimentation by using Andreason apparatus and colter apparatus.

(b) Determination of viscosity: Determination of viscosity is done to assess

the changes that might take place during aging. Emulsions exhibit the non-
Newtonian type of flow characteristics. The viscometer which should be
used maybe a cone and plate viscometer.

(c) Determination of phase separation: This is another parameter

used for assessing the stability of the formulation. Phase separation may
be observed visually or by measuring the volume of the separated
phases.

(d) Determination of electrophoretic properties: Determination of

electrophoretic properties like zeta potential is useful for assessing flocculation since
electrical charges on particles influence the rate of flocculation. Oil in water emulsion
having a fine particle size will exhibit low resistance but if the particle size increase,
then it indicates a sign of oil droplet aggregation and instability.

(e) Electrical conductivity: It is determined by using platinum electrodes

(diameter 0.4 mm, distance 4mm) micro amper metrically to produce a current of 15
to 50 mA. Measurements are made on emulsions stored at room temperature or 37o
C for short time. Stable o/w emulsion offers less resistance, but droplet aggregation
increases resistance. A stable w/o emulsion does not conduct electrodes, but with
the droplet, coagulation conductivity increases.

25
Quality Control Test for Capsules:
1.Appearance: Capsules produced on a small or a large scale should be uniform in
appearance. Visual or electronic inspection should be undertaken to detect any flaws in the
integrity and appearance of the capsule

2.Size and Shape: Hard capsules are made in a range of sizes, the standard
industrial ones in use today for human medicines range from size from 000 (the
largest) to 5 (the smallest) are commercially available. inspection must be done
for size and shape.
3.Unique Identification Markings: Capsule surfaces may bear symbols or other
unique identification markings for better identification.
4. Uniformity of weight.: Weigh an intact capsule. Open the capsule without
losing any part of the shell and remove the contents as completely as possible.
To remove the contents of a soft capsule the shell may be washed with ether or
other suitable solvent and the shell allowed to stand until the odour of the
solvent is no longer detectable. Weigh the shell. The weight of the contents is
the difference between the weighing.00 Repeat the procedure with a further
19 capsules. Determine the average weight. Not more than two of the
individual weights deviate from the average weight by more than the
percentage deviation shown in below and none deviates by more than twice
that percentage. Average weight of capsule Contents Percentage deviation Less
than 300 mg 10 300 mg or more 7.5 TABLE 3 (percentage deviation for capsule
weight)
5.Uniformity of content. This test is applicable to capsules that contain less
than 10 mg or less than 10 per cent w/w of active ingredient. Determine the
content of active ingredient in each of 10 capsules taken at random using the
method given in the monograph or by any other suitable analytical method of
equivalent accuracy and precision. The capsules comply with the test if not
more than one of the individual values thus obtained is outside the limits 85 to
115 per cent of the average value and none is outside the limits 75 to 125 per

26
cent. If two or three individual values are outside the limits 85 to 115 per cent
of the average value repeats the determination using another 20 capsules. The
capsules comply with the test if in the total sample of 30 capsules not more
than three individual values are outside the limits 85 to 115 per cent and none
is outside the limits 75 to 125 per cent of the average value
6. Disintegration. The disintegration test is not applicable to Modified-release
Capsules. For those Hard Capsules and Soft Capsules for which the dissolution
test is included in the individual monograph, the test for Disintegration is not
required.
a) Hard Capsules. Comply with the disintegration test in monograph ,
Unless otherwise directed in the individual monograph use water as the
medium. If the capsules float on the surface of the medium, a disc may
be added. If the capsules adhere to the discs, attach a removable piece
of stainless steel woven gauze with mesh aperture of 2.00 mm to the
upper plate of the basket rack assembly and carry out the test omitting
the discs. Operate the apparatus for 30 minutes unless otherwise
directed
b)Soft Capsules. Comply with the disintegration test Unless otherwise
directed in the individual monograph use water as the medium and add
a disc to each tube. Operate the apparatus for 60 minutes unless
otherwise directed c) Enteric Capsules. Use the apparatus described
under disintegration test (2.5.1), using one capsule in each tube. Operate
the apparatus for 2 hours without the discs in 0.1 M hydrochloric acid.
No capsule shows signs of disintegration or of rupture permitting the
escape of the contents. Replace the medium in the vessel with mixed
phosphate buffer pH 6.8, add a disc to each tube and operate the
apparatus for a further 60 minutes. Remove the apparatus from the
medium and examine the capsules. They pass the test if no residue
remains on the screen or on the underside of the discs, or, if a residue
remains, it consists of fragments of shell or of a soft mass with no
palpable, unmoistened core.
7. Content uniformity of drug: A sample of 30 capsule is taken and 10 are
assayed individually. The drug content of a capsule should be within the limits
of average drug content ±15% and the drug content of none of the capsule fall
outside the average drug content ±25%. If 1-3 capsules falls outside the
average drug content ±15%, the remaining 20 are assayed. The drug content of
27
at least 27 out of 30 assayed should be within the average drug content ±15%
limits. and the drug content of none of the capsules falls outside the average
drug content ±25% limits.

Calibration of Equipment:
Ph meter:
Calibration is a critical step to ensure the accuracy of pH measurements. pH
meters should be calibrated regularly using standard buffer solutions. The
calibration process involves the following steps:
 Selecting Buffer Solutions: Choose at least two buffer solutions that
bracket the expected pH range of the samples being measured. Common
buffer solutions are pH 4.01, 7.00, and 10.01.
 Preparing the Electrode: Rinse the pH electrode with distilled water and
then immerse it in the first buffer solution. Allow it to stabilize for a few
minutes.
 Adjusting the pH Meter: Adjust the pH meter reading to match the
known pH value of the buffer solution. This is typically done using a
calibration knob or button on the meter.
 Rinse and Repeat: Rinse the electrode with distilled water and repeat
the process with the second buffer solution. Adjust the meter again to
match the known pH of the second solution.
 Verification: After calibration, it's advisable to verify the accuracy using a
third buffer solution. If the readings are within an acceptable range, the
pH meter is considered calibrated.

Calibration Frequency:
The frequency of calibration depends on the frequency of use and the
criticality of accuracy in the application. pH meters used frequently may require
daily calibration, while less frequently used meters may be calibrated weekly or
monthly. Additionally, calibration is recommended if the pH meter has been
exposed to extreme conditions or if it has not been used for an extended
period.

High Performance liquid chromatography:

The calibration of a High-Performance Liquid Chromatography (HPLC) system is
a critical process that ensures the accuracy and reliability of the results
28
obtained from the instrument. Here is a general procedure for calibrating an
HPLC system:
 Preparation: Ensure that the HPLC system is clean and that the
calibration is valid. Check that the pump, column, detector, and
processors are properly connected.
 Calibration of Pump for Constant Flow Rate: Start the pump and purge
all the ports with degassed water for 10 minutes. Connect the union
instead of the column. Set the flow at different rates (e.g., 0.25 ml/min,
0.5 ml/min, 1.0 ml/min, 1.5 ml/min, 2.0 ml/min) and measure the actual
flow delivered by the pump.
 Wavelength Accuracy Test for UV Detector: This test checks the accuracy
of the detector’s wavelength. It involves measuring the absorbance of a
reference solution at specific wavelengths and comparing the results
with the known values.
 Linearity of Detector Response: This test checks the linearity of the
detector’s response to different concentrations of a sample. It involves
preparing a series of solutions with different concentrations, measuring
their absorbance, and plotting the results.
 Calibration of Injector & Loop: This test checks the accuracy and
precision of the injector and loop. It involves injecting a known volume
of a sample multiple times and measuring the area of the resulting
peaks.
 Calibration for Gradient Program Test: This test checks the accuracy of
the gradient program. It involves running a gradient program and
measuring the composition of the eluent at different times.
 Column Oven Temperature: This test checks the accuracy of the column
oven temperature. It involves setting the oven to a specific temperature
and measuring the actual temperature inside the oven.
 Carry Over Test: This test checks for any sample carryover from one
injection to the next. It involves injecting a sample followed by a blank
and comparing the results.
After each test, the results are recorded and compared with the specified
limits. If any non-compliance is observed, it is reported to the Head of Quality
Control. All calibration procedures should be documented in a Standard
Operating Procedure (SOP)
Calibration Frequency

29
The frequency of HPLC calibration can vary depending on the specific
requirements and standards of the laboratory or industry. However,
some general guidelines suggest that HPLC calibration should be
performed:
 Quarterly (±7 days) for parameters such as Pressure Test, Drift and Noise,
Column oven and sample cooler, and Pump by flow rate accuracy
measurement.
 Once every six months

UV spectrophotometer:
 Absorption cells
 Control of absorbance
 For UV region
 For visible region
 Photo metric linearity
 Limit of stray light
 Resolution power
 Control of Wavelengths
Absorption cells
 Fill the cuvette with milli-Q water at 240 nm, and absorption is not
greater than 0.093 of the individual cuvette.
 Rotate both cuvettes (180°) one by one.
 Acceptance criteria: On rotation of the cuvette should give an
absorbance difference not more than 0.005.
Control of absorbance:
 For UV region
o Solution A: Prepared 0.005M sulfuric acid:
o Weigh accurately 60.0 mg of potassium dichromate, which
previously dried to constant weight at 130°C in 1000 ml and
dissolved in 0.005 M sulphuric acid.
o Measure the absorbance at 235nm, 257 nm, 313nm, and 350 nm
using 0.005 M H2SO4 as blank.
 For Visible region

30
 o Solution B: Weight about 60.0 mg of potassium dichromate, which
previously dried to constant weight at 130°C and transferred to
100 ml volumetric flask, dissolved in 0.005 M sulphuric acid.
o Measure the absorbance at 430 nm using 0.005M sulphuric acid as
blank.
Acceptance criteria

Soln. type/ wavelengths (nm) Specific abs. Max.Tolerance

Solution A: 235 124.5 122.9 to 126.2

Solution A: 257 144.5 142.8 to 145.7

Solution A: 313 48.6 47.0 to 50.3

Solution A: 350 107.3 104.9 to 108.2

Solution B: 430 15.9 15.7 to 16.1

Photometric Linearity
Weight 50 mg Potassium dichromate and dissolved in 0.005 M Sulphuric acid in
a 50 ml volumetric flask. Further, dilute the above solution in the following way
 1 ml ≥ 100 ml
 2 ml ≥ 100 ml
 3 ml ≥ 100 ml
 4 ml ≥ 100 ml
 5 ml ≥ 100 ml
Take consecutive three readings of each dilution at wavelengths 235, 257, 313,
and 350 nm.
Acceptance criteria:
At each wavelength mean value ≥of 0.999
Limit of stray light

31
Prepares 1.2 % v/v solution by using Potassium chloride in 50 ml Distilled water
and make up the volume up to 100 ml by using distilled water. Run the solution
at 200 nm using water as a blank.
Acceptance criteria: Absorbance at 200 nm should be greater than 2.0
Resolution power
 Prepared 0.02% v/v solution by using toluene in hexane and scanned at
250 nm to 300 nm using hexane as a reference.
 Record the absorption at 269 nm and 266 nm.
 Calculate the absorption ratio by dividing the absorbance at 269 nm
(Maxima) and 266 nm (minima).
Acceptance criteria: The absorbance maxima at 269 nm to the minima at 266
nm should not be less than 1.5.
Control of Wavelengths
 This is a very important test we can verify that instrument wavelength
and the detector is properly working, by using the Holmium perchlorate
method.
 Dissolved 1.0 g of holmium oxide in 1.4 M perchloric acid by heating on a
water bath, keep aside for cool and then dilute to 25 ml by using the
same solvent to prepare a 4.0% w/v solution of holmium oxide.
Calibration of UV-Visible spectrophotometer
Record the spectrum of holmium perchlorate solution from 200 nm to 600 nm
using 1.4 M perchloric acid as a reference solution.
Acceptance criteria

Maxima Wavelength (nm) Maxi. Tolerance (nm)

241.15 240.15 to 242.15

287.15 286.15 to 288.15

361.50 360.50 to 362.50

32
 Maxima Wavelength (nm) Maxi. Tolerance (nm)

536.30 533.30 to 539.30

Studied Equipments:
PH Meter
A pH meter is a scientific instrument used to measure the acidity or alkalinity of
a solution. The pH scale ranges from 0 to 14, where 7 is considered neutral,
values below 7 are acidic, and values above 7 are alkaline. pH meters are
widely used in various industries, including laboratories, environmental
monitoring, food and beverage production, and water treatment.

Components of a pH Meter:
 Glass Electrode: The glass electrode is the primary sensing element of a
pH meter. It consists of a special glass membrane that selectively
interacts with hydrogen ions in the solution.
 Reference Electrode: The reference electrode provides a stable
reference potential against which the glass electrode measures the pH of
the solution.
 pH Meter Probe: The combined glass and reference electrodes make up
the pH meter probe, which is immersed in the solution being tested.
 Meter Display: The pH meter has a digital or analog display that
indicates the pH value of the solution.

UV spectrophotometer
A double-beam UV (ultraviolet)
spectrophotometer is a sophisticated
analytical instrument used for measuring
the absorption of ultraviolet and visible
light by a substance in solution. The
"double-beam" feature refers to the
instrument's ability to simultaneously
measure the sample and reference
beams, providing enhanced accuracy and

33
stability over time. This type of spectrophotometer is widely used in various
scientific disciplines, including chemistry, biochemistry, environmental science,
and pharmaceutical analysis.

Principle of UV Spectrophotometer
The Beer-Lambert Law, also known as Beer's Law, describes the relationship
between the absorption of light by a substance and the concentration of the
absorbing substance. This law is
particularly useful in the
context of UV (ultraviolet)
spectrophotometry, where it is
commonly applied for
quantitative analysis.
The Beer-Lambert Law is
expressed by the equation:
A=ε⋅c⋅l
where:
A is the absorbance of the sample.
ε (epsilon) is the molar absorptivity or molar extinction coefficient, a constant
specific to the absorbing substance.
c is the concentration of the absorbing substance in the solution.
l is the path length of the light through the solution.

Instrumentation of a Double-
Beam UV Spectrophotometer:
 Light Source: The UV
spectrophotometer utilizes
a light source that emits a
broad spectrum of
ultraviolet and visible light.
Common light sources
include deuterium lamps
for the UV range and tungsten or halogen lamps for the visible range.
 Monochromator: The monochromator is responsible for selecting a
specific wavelength of light from the broad spectrum emitted by the light
source. It typically consists of a diffraction grating or prism that disperses

34
 light, allowing only the desired wavelength to pass through to the
sample.
 Sample Compartment: The sample compartment is where the sample
solution is placed for analysis. It usually consists of a cuvette holder that
holds the sample cuvette containing the analyte.
 Detector: The detector measures the intensity of light transmitted
through the sample. Photodiode arrays or photomultiplier tubes are
commonly used detectors in UV spectrophotometers.
 Beam Splitter: In a double-beam spectrophotometer, a beam splitter
divides the incoming light into two beams: the sample beam and the
reference beam. This allows simultaneous measurement of the sample
and reference, providing a baseline for accurate absorbance readings.
 Electronic Control System: The instrument is equipped with an
electronic control system that manages the selection of wavelengths,
controls the intensity of the light source, and processes the detector
signals. Modern spectrophotometers often feature microprocessor
control for increased automation and user-friendly operation.

High Performance Liquid Chromatography

High-Performance Liquid Chromatography (HPLC) is a powerful analytical
technique used for separating, identifying, and quantifying components in a
liquid mixture. It is widely employed in various scientific fields, including
chemistry, biochemistry, pharmaceuticals, and environmental science. HPLC
offers high sensitivity, resolution, and speed compared to traditional liquid
chromatography methods.
Instrumentation of HPLC:
Pump System:
High-Pressure Pump: The pump is responsible for delivering the mobile phase
(liquid solvent) at a constant and precise flow rate. It operates under high
pressure to ensure efficient column packing and separation.
Injector:
Sample Injector: The sample injector introduces the sample into the mobile
phase stream. It typically involves an autosampler for automated and precise
injection of samples.

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Column:
Stationary Phase: The column contains a stationary phase, which is a material
with specific chemical properties that interact with the analyte molecules.
Columns are selected based on the separation requirements.
Packing Material: The column is filled with a packing material, usually silica-
based particles with specific properties, to facilitate the separation of analytes.
Detector:
UV-Visible Detector: UV detectors are commonly used in HPLC to measure
absorbance at specific wavelengths. Other detectors include fluorescence,
refractive index, and conductivity detectors. The choice depends on the nature
of the analytes.
Data Acquisition System:
Chromatography Data System (CDS): A computerized data system collects and
analyzes data from the detector, providing chromatograms that represent the
separation of components.
Mobile Phase:
Solvent Reservoirs: HPLC systems have reservoirs for the mobile phase solvent,
often consisting of a mixture of solvents to optimize separation. The
composition can be varied during a run to achieve different separation
conditions.
Column Oven:
Temperature Control: Some HPLC analyses benefit from precise temperature
control of the column. The column oven ensures temperature stability,
influencing separation efficiency.
Flow Cells and Tubing:
Flow Cells: These cells are part of the detector and are responsible for
interacting with the separated components, leading to the generation of signals
that are converted into chromatograms.
Tubing: The system includes a network of tubing to connect various
components, ensuring a continuous and sealed flow of the mobile phase.

Dissolution Apparatus:
A dissolution apparatus is a laboratory instrument used to evaluate the release
rate of active pharmaceutical ingredients from solid dosage forms, such as

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tablets, capsules, and pellets, into a liquid medium. This process is crucial for
assessing the drug's bioavailability and performance in the human body. The
apparatus simulates the conditions in the gastrointestinal tract, providing
valuable information for drug formulation and quality control.
Construction of a Dissolution Apparatus:
A typical dissolution apparatus consists of the following components:
Vessel: The dissolution vessel holds the dissolution medium (usually a buffer
solution that mimics stomach or intestinal fluids) and the dosage form being
tested.
Paddle or Basket: Two common types of stirring elements are used in
dissolution apparatus: paddles and baskets. The paddle method is suitable for
most dosage forms, while the basket method is often used for capsules and
other forms.
Stirring Element: The stirring element (paddle or basket) facilitates the
movement of the dosage form in the dissolution medium, ensuring uniform
drug release.
Temperature Control System: Maintaining a constant temperature is crucial for
accurate dissolution testing. The apparatus includes a temperature-controlled
bath or jacket to regulate the temperature of the dissolution medium.
Dissolution Medium Reservoir: A reservoir holds the dissolution medium, and a
pump circulates it through the system, maintaining a consistent and
homogenous environment.
Sampling Ports: Sampling ports allow withdrawal of samples at specified time
intervals for analysis.
Detection System: Various detection systems, such as UV-Vis spectroscopy,
HPLC, or other analytical methods, are employed to quantify the amount of
drug released over time.
Testing of Tablets According to IP (Indian Pharmacopoeia):
The Indian Pharmacopoeia (IP) provides guidelines for dissolution testing of
tablets. The procedure involves the following steps:
Preparation of Dissolution Medium:

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Prepare a dissolution medium according to the specifications mentioned in the
IP. The medium should be at the appropriate pH and temperature, reflecting
physiological conditions.

Disintegration Apparatus
A disintegration apparatus is a laboratory instrument used to assess the time it takes for a
solid dosage form, such as tablets or capsules, to disintegrate into smaller particles or
granules. Disintegration testing is crucial in evaluating the potential for a drug to become
bioavailable after administration. The disintegration apparatus ensures that the dosage form
breaks down properly, allowing for the subsequent dissolution and absorption of the drug in
the gastrointestinal tract.
Construction of a Disintegration Apparatus:
A typical disintegration apparatus consists of the following components:
Bath: The bath contains a liquid medium, typically water, and is equipped with temperature
control to maintain the specified testing conditions.
Basket Rack: The basket rack holds individual baskets or tubes in which the dosage forms are
placed during the disintegration test.
Baskets or Tubes: These containers hold the tablets or capsules during the test and allow
water to flow through, facilitating disintegration.
Stirring Element: A stirring element, often a paddle, agitates the liquid in the bath, ensuring
uniform distribution of temperature and preventing the accumulation of dissolved
substances around the dosage form.
Temperature Control System: Maintains the temperature of the liquid medium in the bath at
a specified level.

Leak Test Apparatus

A leak test apparatus is a device designed to detect and measure the presence
of leaks or unwanted fluid or gas escape from a sealed system. These systems
+are widely used in various industries such as automotive, aerospace,
pharmaceuticals, and electronics, where maintaining the integrity of sealed
components is crucial for safety, quality, and performance. The construction
and working of a leak test apparatus can vary based on the specific application
and the type of leaks being tested. However, a general overview can be
provided.
Construction of Leak Test Apparatus:

38
Chamber or Test Enclosure:
The apparatus typically consists of a sealed chamber or enclosure where the
test specimen is placed.
The chamber is constructed to withstand pressure differentials and is made
from materials that do not interfere with the test.
Pressure Source:
A pressure source is required to pressurize the test specimen. This could be
compressed air, nitrogen, or another suitable gas.
Pressure regulators and control valves are used to set and maintain the desired
pressure levels.
Pressure Measurement Devices:
Pressure gauges are integrated to measure the pressure inside the test
specimen.
These gauges provide real-time data, allowing for accurate monitoring during
the test.
Leak Detection System:
The leak detection system is a critical component and can vary based on the
method employed. Common methods include:
 Bubble Test: A submerged specimen is pressurized, and escaping gas
forms bubbles, indicating a leak.
 Pressure Decay Test: Changes in pressure over time are measured, with a
drop indicating a leak.
 Mass Spectrometry: Sensitive detectors measure the composition of the
gas around the specimen.
 Helium Leak Detection: Helium is often used as a tracer gas, and a mass
spectrometer or other sensitive detectors are employed to identify leaks.
Sealing Mechanism:
The apparatus needs to have effective sealing mechanisms to prevent any leaks
from the test environment.
Seals and gaskets are used to ensure a tight closure of the test chamber.
Working of Leak Test Apparatus:

39
Preparation:
The specimen is placed inside the test chamber, and the chamber is sealed.
Pressurization:
The test specimen is pressurized using the chosen gas source. The pressure is
controlled and monitored throughout the test.
Leak Detection:
Depending on the method employed, the apparatus detects leaks through
visual inspection (bubble test), pressure measurements over time (pressure
decay test), or by analyzing the gas composition around the specimen (mass
spectrometry or helium leak detection).

Friability Apparatus:
A Friability Tester is a pharmaceutical instrument used to test the durability or friability of
tablets. This test is crucial for assessing the ability of tablets to withstand abrasion during
transportation, handling, and packaging. Tablets that are too friable may break or crumble
easily, leading to issues with product quality and patient safety. Here's an overview of the
construction and working of a typical Friability Tester:

Construction of Friability Tester:

Drum or Test Chamber:
The key component is a rotating drum or test chamber where the tablets are
placed for testing.
The drum is usually made of transparent or translucent material to allow visual
inspection of the tablets during the test.
Sample Holder:
A sample holder or tablet tray is used to hold the tablets securely in the drum.
It allows easy loading and unloading of tablets before and after the test.
Rotation Mechanism:
The drum is mounted on a rotation mechanism that imparts rotational motion
to the drum.

40
The rotation speed can be controlled to simulate different conditions that
tablets may experience during handling and transportation.
Control Panel:
A control panel allows the user to set and control the test parameters,
including rotation speed and test duration.
Some advanced models may have programmable features and digital displays
for accurate control.
Dust Collection System:
Tablets may produce dust or fine particles during the friability test. A dust
collection system helps in capturing and collecting this material for analysis or
disposal.

Heating Apparatus used in Laboratory:

Muffle Furnace:
A muffle furnace is a type of furnace that provides controlled high-temperature
environments, typically for processes such as heat treatment, ashing, and ignition. The term
"muffle" refers to a separate chamber within the furnace that surrounds the material being
processed. This design allows for a more controlled atmosphere around the sample,
protecting it from direct contact with the heating elements or combustion byproducts

Hot Plate
A laboratory hotplate is a specialized heating device used in scientific laboratories for a
variety of applications, such as heating solutions, conducting chemical reactions, or
evaporating solvents. Unlike conventional hotplates used in kitchens, laboratory hotplates
are designed to meet the specific requirements of scientific experiments.

Vacuum Oven
A vacuum oven is a specialized oven used in laboratories and industries for processes that
require controlled heating under reduced atmospheric pressure or vacuum conditions. This
type of oven is commonly used for drying, heat-treating, and curing materials that are
sensitive to moisture or oxidation.

Hot Air Oven

A hot air oven is a type of laboratory or industrial oven that uses forced convection to
circulate hot air within the oven chamber. This circulating hot air ensures even heating of the

41
contents inside the oven. These ovens are commonly used for various applications such as
sterilization, drying, and baking in industries like pharmaceuticals, microbiology, food
processing, and research laboratories.

Water used in the laboratory

Purified Water (PW):
 Quality Standards: Purified water is produced by a purification process that includes
distillation, ion exchange, reverse osmosis, or other suitable methods.
 Purity Level: It meets the requirements for chemical and microbiological purity as
defined by pharmacopeial standards (such as USP, EP, or JP).
 Uses: Commonly used for non-parenteral pharmaceutical preparations, cleaning
equipment, and as solvent for various dilutions.

Demineralised Water:
 Quality Standards: Deionized water is produced by passing water through ion
exchange resins that selectively remove ions, including both cations (positively
charged ions) and anions (negatively charged ions).
 Purity Level: The deionization process results in water with a very low conductivity,
indicating a high level of purity.
 Uses: It is used in the preparation of buffers and solutions where precise control of
ion concentrations is essential.

Non-Sterile Water:
 Quality Standards: Non-sterile water is used for purposes where sterility is not a
critical requirement.
 Purity Level: It may have a lower level of purity compared to WFI or PW.
 Uses: Non-sterile water may be used in some manufacturing processes where the
absence of microbial contamination is not critical, such as cleaning equipment or
certain formulations.

Sampling of Water
Apparatus required
 Screw capped glass bottles.
 Amber coloured air tight glass bottles for TOC

Glassware preparation
 Wash the sampling bottles thoroughly with water for injection.

42
  For TOC analysis sampling bottles are then treated with nitric acid that will remove
organic matter.
 Use milli-Q/ultra pure type-I water for the final rinse of the sampling bottles.

Sampling Quantity
 Sampling quantity for Pure Steam for all sampling points.
 Sampling quantity for chemical analysis: 500 ml
 Sampling quantity for TOC analysis: 125 ml
 Sampling quantity for purified water and water for injection for all sampling points
except sampling points of storage tank and return line: 1000 ml
 Sampling quantity for purified water and water for injection for sampling points of
storage tank and return line: 1125 ml
 Sampling quantity for chemical analysis: 1000 ml
 Sampling quantity for Raw Water and DM Water: 1250 ml.

Sampling procedure of water

 Wear hand gloves and remove the cap from bottle just prior to obtaining a sample.
 Avoid direct contact of hand to mouth of bottle.
 Open the sampling valve and drain the water to be tested for about 1 to 2 minutes by
opening the valve fully.
 Rinse the sampling bottle by water to be tested.

Sample for chemical analysis

 Collect the water from all sampling points to be tested in glass bottle.
 Cap the bottle.

Sample for TOC analysis

 Collect carefully the water to be tested about 125 ml in amber coloured tight Glass
bottle with minimum head space.
 Keep the Stopper immediately with no head space.
 Examine it with minimum delay.

Testing Of Water
 All tests mentioned in the specification except TOC test will be performed for the
sample collected from all sampling points except sampling points of storage tanks
and return lines.
 Record the result in respective protocol.
 The test TOC will be performed only for the sample collected from sampling points of
storage tanks and return lines as per specification. Rest of all other sampling points
will not be tested for TOC test.
 Perform the sampling of purified water, water for injection and pure steam as
sampling plan.

43
  Testing should be performed within 2 hours from collection of samples, alternatively
keep the samples in refrigerator at 2 – 8°C and analyse within 4 hours. (Allow the
sample to cool room temperature before analysing).

In case of instrument breakdown, shortage of gases or other specific reason,

alternative test shall be performed in urgency such as;

Sr. No. Test Alternative test

1. Total Organic Carbon Oxidisable substances

In case of unavoidable circumstances, the testing parameter shall be

performed in sister concern unit or other competent authorized testing
laboratory.
Release of Water
 Water shall be released daily on the basis of result of Chemical Test and Bacterial
Endotoxin Test.
 If any water quality parameter will be outside of the acceptance limits, consult with
Department Head. The same shall be informed to Concern Department and
Engineering Department.
 In case of instrument breakdown or shortage of gases, water shall be released on the
basis of results of alternative test or on the basis of results of test(s) performed at
sister concern unit or other competent authorized testing laboratory.

Important Factors:
 Sanitization of water system is carried out by engineering team on every weekly off
irrespective of holidays.
 Purified water and water for injection will be sampled after sanitization to check the
pH from the return line of both the plants. Record shall be maintained by Engineering
department.

Sample received from production

 At the time of manufacturing, production chemist will collect the sample of water for
injection from the manufacturing tank and send to Quality Control for analysis with
“INTIMATION SLIP FOR WATER SAMPLE”.

44
  The same water for injection shall be released on the basis of result of Chemical Test
and Bacterial Endotoxin Test.
 If any out of specification is observed, inform to Concern Department.
 The signed Intimation Slip with all results shall be returned to Production
Department.
 The complete analysis record shall be maintained by Quality Control Department

Trends of Water analysis data

 Trend of pH test, conductivity test and TOC test shall be prepared for Purified water
and Water for injection.
 Frequency for trend charts preparation
 Prepare monthly trends for water analysis data of all sampling points.
 Prepare yearly trends for water analysis data of daily sampling points.
 Prepare trends before 10th working day of subsequent month.

Colours Coding
the colours code for different series in a trend chart as below:

Parameters Colour code

Maximum counts Green

Minimum counts Blue

Alert limits Pink

Action limits Red

Recommended Limit Brown

Other Contents Black

45
Future Prospects:
The 45 days training which was done in the quality control department of the Thrift
Pharmaceutical Industry, Raipur division gave me an brief idea of the internal working of a
quality control department in a pharmaceutical industry
It provided me an experience about the individual roles and responsibilities of a Quality
Control chemist. The hands-on training provided me not just with the theoretical experience
but also the practical experience that is vastly required in a pharmaceutical industry.
The diligent training provided by the supervisors helped me in mastering certain equipments
like UV spectrophotometer, pH. Meter, leak test apparatus, HPLC apparatus, and also many
other apparatuses that are required in a quality control lab. It also taught me the basic
requirements, skills, etiquettes required to play an active role in the quality control laboratory
along with good laboratory practices.
The training also helped me Properly in IPQC, document filling and handling, Sampling
procedures and steps required to prevent contamination in the laboratory.
Armed with a comprehensive understanding of regulatory standards, advanced analytical
tools, and effective teamwork, I am well-equipped to contribute to the pharmaceutical sector's
quality assurance practices. This experience not only enhances my employability but also
positions me as a valuable asset in a field where precision and compliance are paramount. As
I step into the professional arena, I am confident that the skills acquired during this training
will prove instrumental in ensuring the continued safety and efficacy of pharmaceutical
products

Conclusion:

46
The 45-day industry training in the Quality Control Department of the pharmaceutical
industry has been an enriching and transformative experience. This period has provided a
comprehensive understanding of the intricacies involved in ensuring the quality and safety
of pharmaceutical products. As I conclude this training, I reflect on the invaluable insights
gained, the skills honed, and the professional growth achieved.
One of the key takeaways from this training is the significance of adherence to regulatory
standards. The pharmaceutical industry operates in a highly regulated environment, and
meticulous attention to quality control is paramount. Through hands-on experience and
exposure to various quality assurance processes, I have acquired a deep appreciation for the
stringent measures in place to guarantee the integrity of pharmaceutical products. The
importance of documentation, compliance, and precision in every stage of production has
become ingrained in my professional ethos.
Additionally, the exposure to cutting-edge technologies and analytical instruments has
expanded my technical expertise. From chromatography to spectroscopy, I have gained
proficiency in utilizing advanced tools for quality assessment. The practical application of
theoretical knowledge has not only enhanced my problem-solving skills but has also
provided a solid foundation for future endeavours in the pharmaceutical sector.
Moreover, the collaborative nature of the Quality Control Department has fostered effective
communication and teamwork. Working closely with seasoned professionals has allowed me
to absorb industry best practices, learn from real-world challenges, and develop a holistic
approach to quality management.
In conclusion, this 45-day industry training has been instrumental in shaping my
understanding of quality control in the pharmaceutical industry. It has been a dynamic and
immersive experience that has not only fortified my technical competencies but has also
instilled a commitment to excellence and compliance. As I embark on the next phase of my
career, I carry with me a profound appreciation for the critical role of quality control in
ensuring the safety and efficacy of pharmaceutical products.

References:

47
 https://pharmaguddu.com
 https://solutionpharmacy.in/evaluation-of-liquid-orals
 https://www.pharmacy180.com
 https://www.pharmaguideline.com
 https://pharmablog.in
 https://pharmastate.academy
 https://www.ipc.gov.in
 https://pharmastate.academy
 Martin's Physical Pharmacy and Pharmaceutical Sciences by Patrick J. Sinko
 Principles of Instrumental Analysis by Douglas A. Skoog; F. James Holler;
Stanley R. Crouch

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