A Practice School report submitted to the

In partial fulfillment of the requirements for the award of Degree of

Bachelor of Pharmacy

Supervised By: - Submitted By: -

Mr. ANKUR GUPTA Mr. ANUP KR. TRIPATHI
Asst. Professor B. Pharma (7th Sem.)
Gyan Vihar School of Pharmacy (2021-2025)

GYAN VIHAR SCHOOL OF PHARMACY,

JAGATPURA, JAIPUR (RAJ.) 302017

1
 DECLARATION

I hereby declare that I have completed the Imparted training in Quality Assurance Department
(Good Documentation Practice) & Production Department work for the partial fulfillment of
the degree of B. Pharm as per rule of Suresh Gyan Vihar University, Jagatpura, Jaipur.

NAME: - ANUP KUMAR TRIPATHI

DATE: -
PLACE: - JAIPUR
SESSION: - (2021-2025)

2
 CERTIFICATE FROM THE SUPERVISOR

This is to certify that Mr. ANUP KUMAR TRIPATHI s/o Mr. BAMDEV TRIPATHI
student of B. Pharma VII Semester has completed his report work in Quality Assurance
Department (Good Documentation Practice) & Production Department entitled is under my
guidance and supervision for the degree of Bachelor of Pharmacy in Gyan Vihar School of
Pharmacy of Suresh Gyan Vihar University, Jaipur.
I also certify that the candidate has put-in more than 85% attendance. He has worked hard,
meticulously, and methodically.
I wish him every success in future endeavors and recommend that this project work to be
forwarded for evolution

MR. ANKUR GUPTA

Asst. Professor
Gyan Vihar School of pharmacy
SGVU, JAIPUR (302017)

3
 FORWARDING CERTIFICATE

This is certified that ANUP KUMAR TRIPATHI s/o MR. BAMDEV TRIPATHI a student
of B. Pharm VII Sem has done the training in Quality control Department (Chemical Lab,
Instrument Lab) & Quality Assurance Department (Good Documentation Practice &
Production Department) under the guidance and supervision of Mr. Ankur Gupta.

He has worked hard, meticulously, and methodically. I wish him every success in future
endeavors and recommend that this project work to be forwarded for evolution.

Dr. HEMANT KR SINGH YADAV

(Head of Department)
GYAN VIHAR SCHOOL OF PHARMACY
SGVU, JAIPUR (302017)

4
 ACKNOWLEDGEMENT

I have great pleasure & dedicated gratitude to those personalities who gave me their valuable
blessings, guidance & esteemed co-operation in motivating me to complete my dissertation
work.
I take this opportunity with pride & immense pleasure expressing my deep sense of
gratitude to my respectable guide Mr. ANKUR GUPTA (Asst. Prof.) whose active
guidance, innovative ideas, constant inspiration, untiring efforts help encouragement &
continuous supervision has made the presentation of dissertation a grand and glaring success.
I also acknowledge to all the honorable people of BROOKS LABORATORIES LIMITED.. team who
had helped me during training period for 30 days and gave their precious time and knowledge as they can
do.
I express my deep sense of gratitude to our, H.O.D Dr. Hemant Kr Singh Yadav, Gyan Vihar
school of pharmacy Jaipur, who has been a perennial source of inspiration for this project.
I am also thankful to all faculty members, laboratory assistants and non-teaching
staffs for their kind cooperation and support each and every day.
And, at last my head bows down in front of almighty that made all things possible, true and
success by his blessing & mentally support.

Mr. ANUP KUMAR TRIPATHI

B. Pharm (VII Sem.)
Enroll. No: - PH010202115508
Session: (2021-2025)

5
6
 CONTENTS
Page no.
1. GENERAL INFORMATION 8-9

2. LAYOUT 10-12

3. RECEIVING / DISPATCH OF MATERIAL 13-14

4. PRODUCTION 15-16

5. PACKING SECTION 17-18

6. LIST OF PRODUCTS 19

7. DOCUMENTATION 20

8. STORES 21-22

9. PERSONAL 23-24

10. QUALITY ASSURANCE 25-26

11. QUALITY CONTROL 27-28

12.RELEASE OF FINISHED PRODUCT FOR SALE 29

13.CONCLUSION 30

7
 GENERAL INFORMATION

 Introduction of the Industry

 Brief History:
The unit of BROOKS LABORATORIES LIMITED is located in Baddi, solan,Himanchal Pardesh
the company is growing pharmaceutical manufacturer in India. This unit of BROOKS
LABORATORIES LIMITED is a dedicated manufacturing facility for tablet, dry syrup,
syrups,injection formulations. The unit Built on ground plus 2 floors, covering more than
7,000 sq. meters. Additional Stores, QC Lab, Microbiology Lab and Document Archives are situated on
the second floor.The plant comprises approximately 300 personnel.There is an independent and
unidirectional flow of workers and raw materials at the plant.The plant is WHO GMP certified.

 Mission:
The mission of the company is to improve global healthcare by delivering high-quality, safe, and
effective medications. It is committed to innovation, patient satisfaction, and meeting the
evolving needs of the pharmaceutical market.

 Vision:
To be a leader in the pharmaceutical industry by consistently providing superior products and
maintaining ethical practices, ensuring long-term value for stakeholders. The company aims to
enhance healthcare access globally while adhering to stringent quality standards and regulations.

 Core Values:
 Patient-Centric Approach: Focusing on patient safety and efficacy.
 Integrity: Maintaining ethical practices across all operations.
 Innovation: Investing in research and technology to develop new solutions.
 Sustainability: Ensuring environmentally friendly manufacturing processes.

8
 Details of Training Program

 Objectives of the Training:

 To provide hands-on experience in pharmaceutical manufacturing processes and quality control.
 To understand the workflow of industrial practices, including raw material handling, production,
and packaging.
 To familiarize with regulatory frameworks, Good Manufacturing Practices (GMP), and quality
standards like ISO and WHO guidelines.
 To gain practical insights into documentation, equipment handling, and standard operating
procedures (SOPs).

 Overview of Pharmaceutical Industry Practices

 Importance in Public Health:
The pharmaceutical industry is a backbone of modern healthcare systems. It addresses critical
health issues by providing medications for various diseases, including chronic and life-
threatening conditions. Its innovations lead to better quality of life, increased life expectancy,
and prevention of pandemics.

 Regulatory Framework:
 The industry operates under stringent regulations to ensure the safety, efficacy, and quality of
drugs. Key global standards include:
 Good Manufacturing Practices (GMP): These guidelines ensure that products are consistently
produced and controlled according to quality standards.
 FDA (Food and Drug Administration): Regulates drug approval in the U.S.
 WHO (World Health Organization): Provides international standards and guidance.
 Drug Controller General of India (DCGI): Ensures compliance within India.

9
 LAYOUT
The plant layout at BROOKS LABORATORIES LIMITED is designed to ensure efficient
workflow, safety, and compliance with Good Manufacturing Practices (GMP). The layout facilitates a
streamlined production process from raw material receiving to finished product dispatch, minimizing
contamination and cross-contamination risks.

 Plant Layout Description:

 The facility consists of interconnected blocks, each designated for specific operations:
1. Administration Block:
o Houses the management offices, meeting rooms, and staff amenities.
o Provides support for the overall coordination of plant operations.

2. Production Block:
o Raw Material Storage Area:
 Dedicated to storing raw materials under specific conditions, ensuring compliance
with temperature and humidity requirements.
 Quarantine areas for untested raw materials until cleared by the QC department.

o Manufacturing Area:
 Equipped with machinery for mixing, formulation, and processing of oral liquids.
 Segregated zones for Non-β lactam production to prevent contamination.

o In-Process Control Laboratory:

 Located within the production block for real-time monitoring and testing during
manufacturing.
3. Warehouse Block:
o Finished Goods Store:
 Dedicated storage area for final products ready for distribution.
 Separate sections for domestic and export goods (if applicable).

10
 o Packaging Material Storage:
 Primary and secondary packaging materials stored under defined conditions.
 Ensures easy access for the packaging team.

4. Change Room:
o Strategically placed near the production area for personnel to change into cleanroom
garments.
o Includes lockers and shoe racks to maintain hygiene and GMP compliance.

 Workflow Explanation:
1. Receiving Raw Materials and Packaging Materials:
o Raw materials are unloaded and stored in the quarantine area.
o Packaging materials are stored separately to avoid mixing with raw materials.

2. Quality Control (QC) Checks:

o Samples of raw materials are sent to the QC laboratory for testing.
o Upon approval, materials are transferred to the raw material store.

3. Material Dispensing:
o Materials are dispensed as per the Master Formula Record (MFR) and moved to the
production area.

4. Manufacturing Process
5. Primary and Secondary Packaging
6. Final QC Testing
7. Dispatch

11
 Diagram of the Plant Layout:

12
 RECEIVING / DISPATCH OF MATERIAL

The efficient handling of raw materials and finished products is crucial for maintaining quality and
ensuring timely delivery. At BROOKS LABORATORIES LIMITED , the processes for receiving
raw materials and dispatching finished goods are streamlined and compliant with regulatory
requirements.

A. Raw Material Procurement:

 Process of Receiving Raw Materials:

1. Material Delivery:
o Raw materials are delivered to the designated receiving area at the facility.
o Each delivery is accompanied by documentation, including:
 Invoice.
 Certificate of Analysis (CoA).
 Delivery challan.
 Batch details and specifications.

2. Quarantine Process:
o Upon receipt, materials are moved to a quarantine area.
o The quarantine area is isolated from other storage zones to prevent cross-contamination.
o Each material is tagged with a quarantine label and recorded in the inventory
management system.\

 Documentation Involved:
 Material Receiving Report (MRR): Documents the receipt of raw materials.
 Goods Received Note (GRN): Confirms the quantity and condition of received materials.
 Sampling Records: Logs samples sent for quality testing.

13
B. Inspection and Quality Checks:

 Sampling and Testing:

 Raw material samples are collected under controlled conditions and sent to the Quality Control
(QC) laboratory.
 Tests conducted include:
o Identification tests.
o Assay for potency.
o Microbial testing (if applicable).
o Checks for physical properties (colour, appearance, particle size, etc.).

C. Dispatch Process:
 Packing and Labelling:
1. Primary Packaging:
o The product is packed into appropriate containers (e.g., bottles for oral liquids) in a clean
environment.
o Primary packaging ensures product safety and integrity.
2. Secondary Packaging:
o Packed products are labeled with all required information, including:
 Product name.
 Batch number.
 Manufacturing and expiry dates.
 Storage conditions.
o Products are placed into cartons for bulk handling.

14
 PRODUCTION

The production process at BROOKS LABORATORIES LIMITED is designed to manufacture high-

quality pharmaceutical products in compliance with GMP standards. This section outlines the key
manufacturing processes, equipment used, and safety measures implemented during production.

A. Overview of Manufacturing Processes:

At BROOKS Labs, the production involves several stages, each critical to ensuring the quality and
consistency of the final product. The specific processes include:

1. Granulation (if applicable):

o Objective: Converts fine powders into free-flowing granules, improving compressibility
and uniformity.
o Process Steps:
 Blending of active ingredients and excipients.
 Addition of granulating liquid (e.g., water, ethanol).
 Wet granulation is dried in a fluidized bed dryer or tray dryer.

2. Mixing and Formulation:

o Ensures uniform distribution of active ingredients in oral liquid formulations.

3. Compression (if tablets are produced):

o Compresses granules into tablets of uniform size and shape.

4. Coating (if required):

o Enhances tablet stability, masks taste, or provides controlled-release properties.

15
B. Equipment Used
Below are the major types of equipment used in the production process:

1. Mixing and Blending:

o High-Speed Mixer: Blends active ingredients and excipients uniformly.
o Planetary Mixer: Used for mixing semi-solid formulations or small-scale batches.

2. Granulation:
o Fluidized Bed Dryer: Dries wet granules efficiently.
o Rapid Mixer Granulator (RMG): Ensures uniform wet granulation.

3. Compression:
o Rotary Tablet Press: Produces tablets with precise weight and hardness.
o Single Punch Press: Used for small-scale production or R&D purposes.

4. Coating Equipment:
o Coating Pan: Applies a thin coating on tablets.
o Fluidized Bed Coater: Used for advanced coating processes.

5. Filling Machines:
o Automatic Liquid Filling Machine: Used for filling oral liquids into bottles.
o Capping and Labeling Machine: Automates the capping and labeling process for
bottles.

6. Packaging Equipment:
o Blister Packaging Machine: For tablet blister packs.
o Cartooning Machine: Packs bottles or blisters into cartons.

16
 PACKING SECTION

The packing section at BROOKS LABORATORIES LIMITED is responsible for ensuring that
pharmaceutical products are securely packaged, correctly labelled, and compliant with regulatory
requirements. This stage involves a combination of automated machinery and manual processes to
maintain efficiency and accuracy.

A. Packing Process
1. Blister Packing:
 Tablets or capsules are placed into pre-formed cavities of a plastic or aluminium
sheet.
 A sealing film (aluminium foil) is heat-sealed onto the cavities to enclose the
product.
 Blisters are cut into required sizes and ejected for secondary packaging.

2. Strip Packing:
 Tablets or capsules are individually sealed between two layers of aluminium foil.
 Heat sealing ensures airtight and light-proof protection.

3. Labelling and Final Packaging:

 Bottles or blister packs are labelled with product details, including the batch
number, manufacturing date, and expiry date.
 Labels are printed and applied using automated machines for accuracy.
 Products are then packed into cartons, which are labelled for shipping.

17
B. Machinery Used in Packing
o Blister Packing Machine
o Strip Packing Machine
o Labelling Machine
o Cartooning Machine
o Shrink-Wrapping Machine

 Workflow Diagram of Packing Section:

18
 LIST OF PRODUCTS

At BROOKS LABORATORIES LIMITED , the company manufactures a wide range of

pharmaceutical products aimed at treating various medical conditions. These products are produced to
meet high-quality standards and are marketed under different therapeutic categories. This section
provides a detailed overview of the types of products manufactured and their therapeutic categories.

A. Manufactured Products
1. Tablets:
o Description: Solid dosage forms containing active pharmaceutical ingredients (APIs)
compressed into a small, convenient shape for oral consumption.
o Examples: Co-Amoxiclav 625mg, ANATE 625 (Co-Amoxiclav 625mg)
Co-Amoxiclav 625LB , Co-Amoxiclav 375mg
ANATE 375 (Co-Amoxiclav 375mg)
2. ORAL SUSPENSION:
o Description: An oral suspension is a liquid medication containing fine particles of an
insoluble drug dispersed in a liquid medium, intended for oral administration.
o Examples:
 Antibiotics (Amoxicillin).
 Antihistamines (Loratadine).
 Nutraceuticals and vitamins (Multivitamins).
3. Dry powder injection :
o Description;- Dry powder injection is a sterile powdered medication that must be
reconstituted with a suitable solvent before administration via injection.
o Examples:
 Iron sucrose 100mg/5ml.
 Drotaverine hydrochloride 40mg/2ml.

DOCUMENTATION
19
At BROOKS LABORATORIES LIMITED , documentation plays a vital role in ensuring the
traceability, quality, and regulatory compliance of pharmaceutical products. This section outlines the
types of documentation used in the pharmaceutical manufacturing process, the importance of
maintaining accurate records, and examples of key documentation formats.
A. Types of Documentation
1. Standard Operating Procedures (SOPs):
SOPs are detailed, written instructions designed to achieve uniformity in the performance of a
specific function. SOPs are critical for maintaining quality and consistency in the manufacturing
process. Some key SOPs include:
o SOP for Manufacturing Process
o SOP for Equipment Calibration
o SOP for Handling Raw Materials
o SOP for Quality Control Testing
2. Batch Manufacturing Records (BMR):
BMR is a document that contains all the instructions required to produce a batch of a particular
pharmaceutical product. It includes details such as:
o Raw materials used
o Manufacturing steps
o Equipment used
o In-process quality control checks
o Packaging details
o Final product yield
3. Testing Records:
o Raw Material Testing Reports
o In-process Testing Records
o Finished Product Testing Reports
4. Logbooks
5. Batch Production Records (BPR)

20
 STORES

Effective storage management is crucial in pharmaceutical manufacturing to ensure that raw materials,
packaging materials, and finished goods maintain their quality and integrity. At BROOKS
LABORATORIES LIMITED , proper storage conditions and inventory management systems are
implemented to comply with regulatory standards and meet the company’s quality objectives. This
section outlines the types of materials stored, storage conditions, and inventory management practices.

A. Storage Conditions
Temperature and Humidity Requirements:
Proper temperature and humidity control are essential for maintaining the stability and efficacy of
pharmaceutical products. All materials, from raw materials to finished goods, are stored under strict
temperature and humidity conditions.

o Raw Materials Storage:

 Temperature: Generally, raw materials such as chemicals, excipients, and active
pharmaceutical ingredients (APIs) are stored at room temperature, typically
between 15°C and 25°C.

 Humidity: Relative humidity (RH) should be kept between 30% and 60% to
avoid moisture-induced degradation of materials.

 Special Conditions: Certain materials like hygroscopic substances may require

controlled environments, such as desiccators or climatic chambers.

o Finished Goods Storage:

 Temperature: Finished goods are usually stored in a controlled area at 18°C to
25°C. Products with special temperature requirements, such as biologics or
vaccines, are stored under refrigerated conditions between 2°C and 8°C.

21
  Humidity: Storage of finished goods must maintain an RH of around 40-60%,
particularly for tablets, capsules, and syrups.

B. Types of Materials Stored

1. Raw Materials:
o Active Pharmaceutical Ingredients (APIs):
These are the core ingredients that make a product therapeutically effective. Examples
include paracetamol, amoxicillin, and ibuprofen.

o Excipients:
These are non-active ingredients used in the formulation, such as starch, magnesium
stearate, and gelatin. These are essential for the manufacturing process.
o Solvents and Chemicals:
Chemicals used for formulations, including water for injection, ethanol, and other
solvents.

2. Packaging Materials:
o Primary Packaging:
Includes materials that come into direct contact with the pharmaceutical product, such as
blister packs, vials, bottles, and tubes.
o Secondary Packaging:
Materials that protect the primary packaging, such as cartons, labels, shrink wraps, and
inserts.

3. Finished Goods:
o Tablets, Capsules, Syrups, Ointments, etc.:
These are the final products ready for sale, which are stored in a well-ventilated, clean,
and secure area to maintain their quality until they are dispatched.

22
 PERSONNEL

Personnel are the backbone of any pharmaceutical manufacturing facility, and at BROOKS
LABORATORIES LIMITED , the team is highly trained and committed to ensuring the production
of high-quality pharmaceutical products. This section discusses the roles and responsibilities of key
personnel, training and development programs, and health and safety measures implemented to
maintain a safe and productive work environment.

 Roles and Responsibilities

1. Production Staff:
The production team is responsible for the manufacturing of pharmaceutical products according
to specified formulations and procedures. Key roles include:
o Production Manager:
 Oversees the entire production process.
 Ensures adherence to Good Manufacturing Practices (GMP).
 Coordinates with the quality assurance (QA) and quality control (QC)
departments.
 Monitors production timelines and material usage.
o Manufacturing Chemists:
 Involved in the preparation, mixing, and processing of raw materials to create the
final product.
 Conducts in-process testing to ensure product quality.
 Operates manufacturing equipment under supervision.
o Operators and Technicians:
 Handle machinery and equipment during production.
 Ensure proper machine setup and maintenance during the manufacturing process.
 Monitor operational conditions (e.g., temperature, pressure) to ensure product
quality.

23
2. Quality Assurance (QA) Personnel:
The QA department is responsible for ensuring that the entire manufacturing process complies
with established quality standards and regulatory requirements.

o QA Manager:
 Responsible for the overall quality assurance program.
 Develops, implements, and monitors SOPs and quality management systems.
 Oversees product testing, audits, and inspections.
o QA Officers:
 Monitor production processes to ensure they comply with quality standards.
 Conduct audits and ensure documentation is accurate.
 Coordinate with the QC department to ensure proper testing of raw materials and
finished goods.

3. Quality Control (QC) Personnel:

The QC department is responsible for testing raw materials, in-process materials, and finished
products to ensure they meet the required specifications.

o QC In-Charge:
 Supervises QC activities, including testing of raw materials, in-process samples,
and finished products.
 Reviews test results and ensures that products meet safety and efficacy standards.
 Ensures that laboratory equipment is calibrated and maintained.
o QC Technicians

4. Warehouse Staff:
o Warehouse Manager
o Warehouse Operators

24
 QUALITY ASSURANCE
Quality Assurance (QA) is a critical aspect of pharmaceutical manufacturing. It ensures that products
are consistently produced and controlled according to quality standards. at BROOKS
LABORATORIES LIMITED, QA processes are designed to guarantee that every product meets
regulatory requirements, safety standards, and customer expectations. This section outlines the
overview of QA processes, compliance with regulations, and the importance of QA in the
pharmaceutical industry.
A. Overview of QA Processes
1. Validation Processes:
Validation is a key component in ensuring the consistent production of high-quality
pharmaceutical products. It involves confirming that the processes, systems, and equipment used
in production meet predefined standards and consistently perform as expected.
2. Calibration Processes:
Calibration ensures that all measuring and testing equipment used in the manufacturing process
are accurate and functioning properly. This includes equipment such as balances, temperature
sensors, pressure gauges, and pH meters. Proper calibration of these instruments is critical in
guaranteeing that raw materials and final products meet the required specifications.
3. In-Process Quality Checks:
In-process checks are carried out at various stages of production to ensure that the product is
being manufactured within the required specifications. These checks help identify any issues
before the product reaches the final stages of production, minimizing the risk of defective
products reaching the market.
B. Compliance with Regulations
1. Good Manufacturing Practices (GMP):
GMP is the foundation of quality management in pharmaceutical manufacturing. The GMP
guidelines, as defined by regulatory bodies such as the FDA, WHO, and the Indian Drugs and
Cosmetics Act, provide a framework for the design, operation, and monitoring of the
manufacturing process to ensure that products are consistently produced and controlled
according to quality standards.

25
2. ISO Standards:
In addition to GMP, BROOKS Labs Private Limited adheres to internationally recognized ISO
(International Organization for Standardization) standards, including:
 ISO 9001: Focuses on quality management systems (QMS). This standard ensures that the
company has a structured approach to ensuring customer satisfaction and regulatory compliance.
 ISO 13485: Relevant for the manufacturing of medical devices and pharmaceuticals, ensuring
consistent quality throughout the product lifecycle.
 ISO 17025: Focuses on laboratory competence, ensuring that testing and calibration laboratories
are reliable and accurate.
Raw Material Inspection
↓
Process Validation
↓
In-Process Quality
Checks & Sampling
↓
Final Product Testing
↓
Batch Record Review
↓
Release for Sale
↓
Regulatory Compliance
↓
Continuous Improvement

26
 QUALITY CONTROL

Quality Control (QC) is a crucial component of pharmaceutical manufacturing, focusing on testing and
ensuring the quality of raw materials, in-process products, and finished goods. The goal of QC is to
guarantee that all pharmaceutical products meet the required specifications for safety, efficacy, and
quality before being released for sale. At BROOKS LABORATORIES LIMITED, the QC
department plays a vital role in ensuring that all products meet the highest standards of pharmaceutical
quality.

A. Testing Procedures:
Testing procedures at BROOKS LABORATORIES LIMITED are designed to evaluate raw
materials, intermediate products during the manufacturing process, and the finished goods to ensure
they meet predefined quality standards. The key areas of testing include:

1. Raw Material Testing:

o Purpose: Raw materials such as active pharmaceutical ingredients (APIs), excipients,
and packaging materials are tested before being used in the manufacturing process to
confirm their quality and compliance with specified standards.

o Tests Performed:
 Identity Test: Verifies the chemical composition of the material to ensure it is
what it is supposed to be.

 Purity Test: Confirms that the material is free from impurities and contaminants.

 Content Uniformity: Ensures that the material has a consistent concentration of

the active ingredient.

 Microbiological Testing: Determines the absence of harmful microbial

contaminants.

 Moisture Content: Checks for the correct moisture content in raw materials that
could affect stability.

2. In-Process Testing:
In-process testing is done during manufacturing to monitor the quality of the product at various
stages and ensure that the final product meets the required specifications.
27
o Key Tests:
 Granulation Testing: Measures properties such as particle size distribution, flow
properties, and moisture content of granules.

 Tablet Weight Variation: Ensures uniformity in tablet weight to comply with

dosage specifications.

 Tablet Hardness and Friability: Assesses the strength and breakability of

tablets.

 Dissolution Testing: Determines how quickly and completely the active

ingredient dissolves in a specific solution, which is essential for drug absorption.

28
 RELEASE OF FINISHED PRODUCT FOR SALE

The process of releasing a finished product for sale is the final stage in pharmaceutical manufacturing.
It ensures that only high-quality products reach consumers. This process involves a final inspection,
regulatory approvals, and the distribution of the product to the market. AtBROOKS
LABORATORIES LIMITED, the release of finished products for sale is done in strict compliance
with pharmaceutical regulations, industry standards, and company policies.

A. Final Inspection: Checklist Before Release

Before any finished product is released for sale, it undergoes a comprehensive final inspection to
ensure that it meets all quality, safety, and regulatory requirements.
 The checklist for final inspection includes:
o Product Identification and Labeling
o Packaging Integrity
o Batch Record Review
o Final Quality Control Testing
o Stability Testing Results
o Compliance with Regulatory Standards
o Documentation

B. Regulatory Approvals: Ensuring Compliance with Drug Controller Authority

For a pharmaceutical product to be legally marketed and sold in India, it must receive approval from
the Drug Controller General of India (DCGI). This regulatory authority ensures that all pharmaceutical
products meet stringent safety, efficacy, and quality standards.
 The following steps are involved in securing regulatory approval:
o Approval for Manufacturing
o Approval for Finished Product
o Regulatory Compliance
o Labeling and Packaging Approval

29
 CONCLUSION

The release of finished products for sale is one of the most crucial stages in pharmaceutical
manufacturing, ensuring that only safe, effective, and compliant products reach consumers. At
BROOKS LABORATORIES LIMITED, this process is carried out with the highest standards of
quality control, regulatory compliance, and operational excellence.

From the final inspection to regulatory approval and distribution, each step is meticulously
documented, verified, and executed to guarantee that all products meet the established safety and
quality standards. The final inspection is thorough, covering every aspect of the product, from labeling
and packaging to in-depth quality control testing, ensuring that the finished product is both safe for use
and fully compliant with the regulations of the Drug Controller General of India (DCGI) and other
governing bodies.
In addition to product quality and safety, BROOKS LABORATORRY places a strong emphasis on
post-market surveillance. Continuous monitoring of products in the market, along with customer
feedback, ensures that any potential issues are identified and addressed promptly. This ongoing process
of feedback and improvement helps in maintaining a long-term commitment to customer safety and
satisfaction.

Overall, BROOKS LABORATORIES LIMITED ensures that the entire process from
manufacturing to market release is carried out in a manner that upholds the highest standards of quality,
safety, and regulatory compliance. By adhering to these rigorous protocols, BROOKS Labs contributes
to the health and well-being of the community, offering effective pharmaceutical solutions while
maintaining trust with regulatory bodies, healthcare professionals, and consumers. This comprehensive
approach guarantees that Labs’ products remain a reliable choice in the pharmaceutical industry.

30