A

PROJECT REPORT
ON
“INDUSTRIAL TRAINING REPORT”
SUBMITTED TO
VEER MADHO SINGH BHANDARI UTTARAKHAND
TECHNICAL UNIVERSITY, DEHRADUN

Submitted in partial fulfilment of the requirement for the degree of

BACHELOR OF PHARMACY
By:
AAKASH PANWAR
(Roll No: - 190250300001)

Under the Supervision of

Mr. WASIF RAO
(Assistant Professor)

ROORKEE COLLEGE OF PHARMACY

(2022-23)
 ACKNOWLEDGEMENT

It is my pleasure to be indebted to various people, who directly or indirectly

contributed in the development of this work and who influenced my thinking,
behaviour, and acts during the course of study.
I express my sincere gratitude to Mr. WASIF RAO and Mr. KASHIF for
providing mean opportunity to undergo Industrial Training at Manufacturing
Unit: Apple Formulations Pvt. Ltd. Plot No.208, KH.No.445, Dehradun
Road, National Highway 73, Kishanpur Jamalpur, Uttarakhand 247667
India.
I am thankful to Dr. RAJEEV TOMAR for providing to me constant inspiration
with his presence and also guidance for my future endeavours, during the course
of training.

Lastly, I would like to thank the almighty and my parents for the immoral support
and my mentor with whom I shared my experience and received lots of
suggestions that improved my quality of work.
 DECLARATION

Myself AAKASH PANWAR student of Bachelor of Pharmacy studying at

Roorkee College of Pharmacy, Roorkee, hereby declare that the training report
on “Analytical Facilities of Apple Formulations Pharmaceuticals Ltd”
submitted to Roorkee College of Pharmacy in fulfilment of Degree of Bachelor
in Pharmacy is the original work conducted by me. The information and data
given in the report is authentic to the best of my knowledge.

Mr. AAKASH PANWAR

 CERTIFICATE

The work described in this initiated “INDUSTRIAL TRAINING REPORT”

has been carried out by Mr. AAKASH PANWAR. I certify that this is his
bonafede work. The work described is original and has not been submitted for
any degree to this or any other university.

Place: Roorkee, Uttarakhand

Submitted to:
Mr. WASIF RAO
Asst. Professor,
Roorkee College Of Pharmacy
Roorkee ,Uttarakhand
 STATEMENT BY THE CANDIDATE

As required by university regulation, I wish to state that this work embodied in

this report titled “INDUSTRIAL TRAINING” forms my own contributions.
This work has not been submitted for any degree of this or any other university.

Mr. AAKASH PANWAR

Submitted to: -
Mr. WASIF RAO
Asst. Professor,
Roorkee College Of Pharmacy
Roorkee ,Uttrakhand
 CONTENTS

Sr. No. Particulars Page no.

1. Introduction 1

2. Client list 10

3. Product profile 12

4. Plant Layout 26

5. Storage Areas 28

6. Packaging 29

7. Markets 31

8. Quality 32

9. Facilities 34

10. Training Letter 36

11. Conclusion 38
 INTRODUCTION

ABOUT THE COMPANY

APPLE FORMULATIONS PVT.LTD

Company Profile

APPLE FORMULATIONS is a professionally managed pharmaceutical

company constituted as per WHO-GMP guidelines in Excise Free Zone at
Roorkee Haridwar commissioned in 2006. It manufactures a wide range of
compressed Tablets (Uncoated/film coated/enteric coated/sugar coated &
sustained release) & Liquid orals (Syrups, Suspensions) and external preparation
The Promoter-Directors of the company have wide experience of the line as we
are running a similar manufacturing unit at Indore in the name of Ceza
Formulations Pvt. Ltd
Embedded in the very core of Apple formulations is a passion for transforming
the pharmaceutical industry worldwide. We are a prominent global
pharmaceutical company offering branded & generic formulations,
biotechnology products, active pharmaceutical ingredients (APIs), and specialty.
We are also one of the most significant players in the domain of medicinal
production and distribution in the areas of Gynaecology, Cardiovascular,
Diabetology, Asthma, Paediatric Care, Central Nervous System (CNS), Gastro-
Intestinal (GI), Anti-Infective (AI), and Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs). All our facilities are approved by international regulatory agencies,
with research and development sites across the globe.

1
We are equipped with the modern facilities to manufacture a wide range of
compressed Tablets (Uncoated/film coated/enteric coated/sugar coated &
sustained release) & Liquid orals (Syrups, Suspensions) and External preparation.
Keeping up with the present scenario of excise laws we have located our
manufacturing operations at the state-of-the-art plant in EXCISE EXEMPTED
AREA at Kishanpur, Roorkee, and located 25 km from Haridwar. Spread over
2700 sq. yds of verdant, picturesque surroundings, amidst lush green lawns and
thick foliage, the site is away from humdrum of typical industries area, free from
congestion and pollution. Apple Formulations is a professionally managed
pharmaceutical company constituted as per WHO-GMP guidelines and
commissioned in 2006.

Truly unique in every sense of term, the plant’s standards and facilities can match
any other, worldwide. Apart from the manufacturing facility it is our professional
attitude and corporate philosophy which can be of advantage to our strategic
partners.

2
 INVOLVEMENT

It is involved in
• Pharmaceutical Testing
• Food Testing
• Water Testing
• Testing of Herbal products and Nutraceuticals
• Medical Device Testing
• Testing of Cosmetic Products
• Building and Construction Material Testing
• Pre-shipment inspection and sampling of consignments
• Environmental monitoring and testing of environmental samples

Apple Formulations specialize in wide gamut of therapeutic segments and

nutritional supplement for Human Division, including:

• Antibiotics
• Anti Ulcer ant
• Anti Fungal
• Anti Histaminic
• Anti Viral
• Calcium Channel blocker
• Analgesics /Anti-inflammatory
• Hematinic
Apple Formulations has also set up Animal Health Division, which primarily
manufacture feed supplements & pharmaceuticals for this segment. At present is
strongly positioned in several states in India & are on the mission to expand
market in domestic & International arena.

3
 QUALITY POLICY

We believe that quality is soul of Pharmaceutical Formulation Company. Aim of

quality system is to ensure that standard quality products are manufactured in
quality environment using standard processes and materials. To achieve this goal
comprehensive quality system is implemented where by each and every material,
process, procedure and activity is standardized, validated &documented.

Quality Assurance and Quality Control departments are heart of our quality
system, Our Quality Assurance Department is responsible for formulating and
implementing quality system. It also investigates shortcoming of system and take
preventive and corrective actions as may be required.

Quality Control department analysis APIs, excipients, primary & secondary

packing materials, semi-finished & finished formulations and water quality for
integrity of the final product. We have in house Physico- Chemical, Instrumental
& Microbiological testing labs equipped with state of the art instruments.

To assure stability of the product stability studies are carried out on regular basis.
We want to grow through strict adherence to our Quality management systems.

4
 Mission and Vision
Mission

Apple Formulations has a corporate mission – We will discover, develop and

successfully market Pharmaceuticals products to prevent, diagnose, alleviate and
cure.

We shall provide total customer satisfaction and achieve leadership in chosen

markets, products and services across the globe, through excellence in
technology, based on world-class research and development

Vision

To Heal And Nurture Mankind In Every Possible Way And Become A Company
Par Excellence In The Field Of Pharmaceutical Formulation Sector

Manufacturing Process

As one of the key players in the Indian pharmaceutical industry, the Apple
Formulations Group has well-established manufacturing capabilities

Teamwork

We align our multidimensional teams across different levels and pour in resources
from all directions to deliver outstanding results to our clients, customers, and
stakeholders.

Personal Growth

Our personnel is empowered to build a sense of ownership to the firm, assume

his/her responsibilities with a complete understanding of the stakes, and grow
his/her own professional portfolios alongside in a healthy and balanced manner.

Customer Focus

All our research, investigation, and analysis forced at aimed at understanding

consumer requirements, demands, and circumstantial needs- information

5
Integrity

We shall be clear, honest and sincere in all our dealings within our team and
business partners

Commitment

We shall uphold ethical practices, fulfil our promises and strive to be a good
corporate citizen

Quality

we shall achieve the highest manufacturing and operating standards through

continuously updating and improvising in all activities

Recognition

We shall reward achievements, encourage innovations and drive individuals

towards highest levels of performance

Ownership

We shall take pride in being committed, with an ever-growing sense of

belongingness to Apple Formulations family through our every act and deed

6
 CONTRACT-MANUFACTURING
Businesses today thrive by focusing on what they do best and leaving the rest to
others. Contract manufacturing seems to fit neatly into this practice. In addition
to allowing companies to focus on core competencies,

APPLE FORMULATIONS offer numerous other advantages over in-house

manufacturing, including lower costs, flexibility, access to external expertise
and reduced capital. APPLE FORMULATIONS Success in contract
manufacturing is lead by factors such as product quality, cost
competitiveness, delivery schedule and CM/Customer relationship.
WHY YOU SHOULD CHOOSE APPLE AS PREFERRED CHOICE FOR
PHARMACEUTICAL CONTRACT MANUFACTURING

• At "APPLE" We believe in delivering nothing but the best.

• Adequate facilities for manufacturing and EXTERNAL
APPLICATIONS.IONS.
• Scope Of Contract Manufacturing Alliance With Bigger Companies.
• We offer contract manufacturing of all dosage forms.
• Depending on needs of our valued clients, our services include
purchasing of raw materials, production, packaging and quality control.
• Through this flexible approach, we are able to integrate perfectly into
supply chain for solid dosage forms. Monitor and optimize the timelines
of our delivery and keep it up to our customer’s full satisfaction.
• Quality is an important part of almost all projects. We add value across
the entire production chain, from buying the raw materials until the
finished products leave the plant. What feels best is when we succeed
with improvements, resulting in better operations.

Manufacturing System.

• State-of-the art facilities, which adhere to stringent specifications..

• Productions fully automate system for production with online controls
and inventory, highly qualified and trained staff for production
management.
• Capabilities to produce dosage forms in sterile and general, covering all
therapeutic segments except small and large volume parentrals which
are in pipe line and shall be installed in a short period of time.
• Qualified and experienced technical team in the areas of manufacturing,
quality control, quality assurance, product development, for all range of
products
7
Highlights of manufacturing facility
• No wood or asbestos components.
• Each zone has separate AHUs (Air Handling units), dehumidification
unit and dust extraction systems.
• Segregation of every critical processing activity in each zone, to avoid
cross-contamination.

Respective zones, areas.

• Air environment conditioned in each area with respect to temperature,
humidity, filtration, particle counts, etc.
• Duo passes reserve osmosis (RO) water system/ de-mineralization plant.
• Zero-discharge Effluent Treatment plant.
• Conditioned stores for raw materials. Packaging materials and finished
goods.
• The complex also houses its R&D facility for in house product
development.

Formulations services/capabilities
• Formulation development for new chemical entities(NCE).
• Optimization of existing formulations.
• Process development for selected dosage forms.
• Novel formulations for improved delivery of existing dosage forms.
• Controlled or sustained release formulations.

CM/Customers Relationship
We know that the success of contract manufacturing depends on the mutual
understanding between the contract manufacturer and the customers. The former
must know how to service the latter, and must make clear his requirements (to the
customer) in advance. The relationship depends on mutual trust, and hence the
communication between the two parties must remain open. This will help both
the sides to understand the requirements of maintaining the partnership.

Delivery Schedule
Time is money for us. As All Contract manufacturer demand that their products
be delivered within contractual time frames. The success of a CM largely depends
on whether it is capable of meeting this requirement of Customers. Maintaining
a Consistent and strict delivery schedule involves close planning of the entire
production. Such a planning involves; Control of incoming materials.

8
Maintaining an operating schedule of the production line. This can be taken care
of by determine .

• Avail EXCISE and C.S.T. benefits.

• Schedule ‘M’ & GMP compliance.
• Plant set-up under W.H.O. guidelines.
• State of the art laboratory.
• Fully automatic liquid line.
• Latest and modern machines and equipment.
• Technical staff with experience of over 30 years.
• Procurement of Raw material & Packing material from the approved
venders or reliable sources.
• Stringent quality norms met at each stage of manufacturing process to
ensure that what you get is truly a quality product in terms of
manufacturing, packaging and is value for money.
• The products shall meet relevant internal and pharmacopoeia standards and
the statutory requirements.
• Quicker approval for your products from Drug Controlling and Licensing
Authority

Business Activities:
• Contract Manufacturing.
• Domestic Sales / Domestic Marketing.
• Export.

9
 CONCLUSION

The Contract Manufacturing business is growing at a very good pace, and

APPLE FORMULATIONS PVT LTD is making profitable use of this
opportunity. Our success as Contract Manufacturer in the field of pharmaceutical
formulation depends mainly on our product quality, low production cost, on-time
delivery and the CM/Customer, Client relationship. Positively, Process
optimization and training of production personnel is also playing a crucial role to
achieve goals of our organization.

10
 CLIENT LIST
At present APPLE FORMULATIONS PVT LTD proudly announces that it has
a list of satisfied customers from different geographical locations of the world.
Our customers always look to us with a hope that whatever we deliver will have
unmatched quality standards. We as a company lay a lot of emphasis on rendering
a pleasant experience every time, they deal with us. Our belief lies in developing
long lasting strategic relations with our customers and this has helped us in
maintaining a long list of clienteles that includes names like.

11
 PRODUCT PROFILE

Apple Formulations Limited has a huge product basket includes Branded and
Generic Formulations covering the majority of therapeutic segments for all oral
dosage forms.

Apple Formulations is a manufacturer of pharmaceutical formulations mainly

Human

At present Apple Formulations is in the process of consolidation of the product

portfolio in the selected segment and are looking to further strengthen its
offerings. Apple Formulations is also concentrating its efforts to build and
enhance portfolio in the chronic health, nutraceutical and food segment, thus
creating a healthy balance of both acute and chronic therapies.

• More than 1000 formulations

• Generics

• Branded Generics

• NDDS

Therapeutic Categories

• Antibiotics

• Ami Tubercular

• Anti Epileptic

• Antacid

• Anti Diabetic

• Anti Malarial

• Anti Histaminic

• Cardio Vascular

12
 • Anti Diarrhea

• Laxative

• Anti Migraine/ Anti Vertigo

• Cough Medicine

• Analgesics/ Antipyretics

• Anti Asthmatic

• Psychotropic

• Anti Emetic/ Anti Nausea

• Steroids

• Minerals/ Calcium

Global Presence

On grounds of Global Presence, Apple Formulations – especially through its

rapidly expanding product ranges - intends to position itself as a market leader
internationally.

India

Apple Formulations has been present in India for over 30 years and has
established a strong presence in the – ethical - pharmaceutical market across the
country. Our Marketing and Sales team at Apple Formulations consist of highly
qualified and capable professionals who strive for excellence in marketing
medicines of the highest standards to the medical fraternity and disseminating the
latest medical updates about current brands and future products. Ensuring the
availability of products at maximum retail pharmacies across our area of
operations is another distinct strength. In addition, continuous monitoring of the
disease patterns, of the need of practicing doctors and of our R&D initiatives are
built into our aggressive corporate growth plan.

13
 CATEGORY-LIQUID

SR. SR.
Product Composition Product Composition
NO. NO.
Each ml contains :- Each ml contains :- IP 125mg
Paracetamol IP 100mg Paracetamol
1 Colour: Ponceau 4R 2 Colour: Ponceau 4R
In a flavoured syrupy base In a flavoured syrupy
base
Each 5ml contains :- Each 5ml contains :-
3 Paracetamol IP 120mg 4 Paracetamol IP 240mg
Colour: Erythrosine Colour: Erythrosine
In a flavoured syrupy In a flavoured syrupy
base base
Each 5ml contains :- Each 5ml contains :-
5 Paracetamol IP 125 mg 6 Paracetamol IP 250mg
Colour: Ponceau 4R Colour: Ponceau 4R
In a flavoured syrupy In a flavoured syrupy
base base
Each ml contains :- Each 5ml contains :-
7 Paracetamol IP 150mg 8 Albendazole IP 200 mg
Approved colour
used
Colour: Sunset Yellow FCF
In a flavoured syrupy
In a flavoured syrupy
base
base
Each 15ml contains :- Each 5ml contains :-
9 Lactulose Concentrate 10 Ofloxacin IP 100mg
USP
Colour: Sunset Yellow
eqv. to Lactulose FCF
10gm
In a flavoured syrupy
Aqueous base q.s. base
14
 Each 5ml contains :- Each ml contains
Ambroxol Dicyclomine Hydrochloride
Hydrochloride IP 10mg
IP 15mg
12 Simethicone
Terbutaline Sulphate 1.25mg IP 40mg
IP Colour: Sunset Yellow FCF
11 Guaiphenesin 50mg In a flavoured syrupy base
IP
1mg
Menthol IP
Each 5ml contains :-
Colour:Ponceau 4R
Ondansetron
In a flavoured syrupy Hydrochloride IP
base
14 Eqv.to Ondansetron 2mg
Colours:Tartrazine &
Each 5ml contains :- Carmoisine
13 Lactulose Concentrate In a flavoured syrupy
USP base
eqv. to Lactulose Each 5ml contains
3.335gm Aqueous base :Mefenamic Acid
q.s. IP 50mg
16 Paracetamol
IP 125mg
Colour: Sunset Yellow
Each 5ml contains :- FCF
Albendazole
IP 200 mg
Each 5ml contains :-
15 Ivermectin 3mg
Paracetamol IP 125mg
IP
Phenylephrine Hydrochloride 2.5mg
Colour: Sunset Yellow
IP
FCF
17 Cetirizine Dihydrochloride 2.5mg
In a flavoured syrupy
IP
base
Colour: Ponceau 4R
In a flavoured syrupy base

15
CAPSULES
Each hard gelatin capsule Each hard gelatin capsule IP 40 mg
contains: contains: Pantoprazole
IP 30mg
Sodium
Rabeprazole Sodium IP
20mg eqv. to. Pantoprazole
(as enteric coated pellets) (as enteric coated pellets)
1 Domperidone IP 30mg 2 Domperidone
(as immediate release 10mg & (as sustained release
sustained release 20 mg pellets) pellets)
Excipients q.s Excipients q.s
Approved colour used in empty Approved colour used in
capsule shells empty capsule shells

Each hard gelatin capsule Each hard gelatin capsule contains:

contains:
Omeprazole IP
Rabeprazole Sodium IP 20mg
20mg
4 (As enteric coated granules )
(as enteric coated pellets)
Domperidone IP 10mg
3 Domperidone IP 30mg
Excipients q.s
(as sustained release pellets)
Approved colour used in empty
Excipients q.s capsule shellsq.s.
Approved colour used in empty
capsule shells

Each hard gelatin capsule Each hard gelatin capsule contains:

contains:
Itraconazole BP 200mg
Itraconazole BP 100mg
5 6 Excipients q.s.
Excipients q.s.
Approved colour used in empty capsule
Approved colour used in empty shells
capsule shells

16
 Each hard gelatin capsule Each hard gelatin capsule IP
contains: contains:
Pantoprazole Sodium Rabeprazole Sodium
IP eqv. to.
(as enteric coated pellets)
Pantoprazole
Levosulpiride
(as enteric coated pellets) 40 mg 8
(as sustained release
7 Levosulpiride 75mg pellets)
(as sustained release q.s. 20mg
Excipients q.s
pellets) 75mg
Approved colour used in
Excipients q.s empty capsule shells q.s.
Approved colour used in
empty capsu

Each hard gelatin capsule Each hard gelatin capsule

contains: contains:
Esomeprazole Magnesium Methylcobalamin IP
IP
Alpha Lipoic Acid USP
Eqv.to Esomeprazole 40mg
9 Domperidone IP 30mg 10 Pyridoxine HCl IP Folic 1500mcg
Acid IP
100mg
(as sustained release pellets)
Excipients q.s
3mg
Excipients q.s
Approved colour used in
1.5mg
Approved colour used in empty empty capsule shells
capsuq.s.

Each hard gelatin capsule

contains:
Omeprazole
IP 20mg
11 (as enteric coated pellets)
Excipients q.s
Approved colour used in empty
capsule shells

17
TABLETS
Each film coated tablet Each film coated tablet
contains: contains :-
Ofloxacin IP 200mg Ofloxacin IP 400mg
1 Excipients 2
q.s. Excipients
q.s.
Colour : Quinoline
Yellow Colour: Sunset Yellow
FCF
Each film coated tablet Each film coated tablet
contains: contains:
Ofloxacin IP 200mg Ciprofloxacin Hydrochloride
IP
3 Ornidazole IP 500mg 4 eqv. to Ciprofloxacin 250mg
IP
Excipients
q.s. Excipients q.s.
Colour : Sunset yellow Approved colour used
FCF

Each film coated tablet Each film coated tablet

contains: contains:
Ciprofloxacin Levofloxacin
Hydrochloride IP Hemihydrate IP
5 eqv. to Ciprofloxacin 500mg 6 eqv. to Levofloxacin 250mg
IP Excipients
Ornidazole IP
q.s.
500m
Excipients q.s
Approved colour used g
Colours: Red Oxide of
Dioxide IP
Iron & Titanium

18
 Each film coated tablet
contains:
Each film coated tablet
contains: Levofloxacin
Hemihydrate IP
Norfloxacin IP 400mg
8 eqv. To Levofloxacin 500mg
7 Tinidazole IP 600mg
Excipients
Excipients
q.s
q.s.
Approved colour used
Approved colour used

Each film coated s:

tablet contain
IP
Norfloxacin 200mg Each uncoated tablet
contains:
9 Metronidazole IP 200mg
Amlodipine Besylate IP
Excipients q.s. eqv.to
Approved colour 10 Amlodipine 2.5mg
used
Excipients q.s
Colour :Red oxide of Iron
Each uncoated tablet contains:
Amlodipine Besylate IP
Each uncoated tablet
11 eqv.to Amlodipine 5mg contains:
Excipients 12 Amlodipine Besylate IP
q.s. eqv.to Amlodipine 10mg
Approved colour used Excipients q.s

Each film coated tablet

Each uncoated tablet contains:
contains: Olmesartan Medoxomil IP 40mg
Amlodipine Besylate IP
14 Amlodipine Besylate IP 5mg
13 eqv.to Amlodipine 5mg eqv.to Amlodipine
Atenolol IP 50mg Excipients q.s.
Excipients q.s
Colour :Titanium Dioxide IP

19
External Preparations

Composition:
1 Gammabenzene 0.1%w/v Composition:
Hexachloride IP
q.s. 2 Gamma Benzene IP 1%w/v
Aqueous Base Hexachloride
IP 0.1%w/v
Cetrimide

Composition: In an emulsion base

3 Gamma Benzene 0.1%w/v

HexachlorideIP Composition:
0.1%w/v
Cetrimide IP Lindane IP 1%w/v
In an emulsion base
4 Cetrimide IP 0.1%w/v
Approved colour used

Composition: In an emulsion base

Diclofenac
Diethylamine BP 1.16%w/w
Composition:
Eq.to Diclofenac IP 1.0%w/w
Sodium Diclofenac
Diethylamine BP 1.16%w/w
Methyl Salicylate IP 10%w/w
Eq.to Diclofenac IP 1.0%w/w
5 Linseed Oil BP 3%w/w Sodium
Menthol IP 5%w/w Methyl Salicylate IP 10%w/w
Benzyl Alcohol IP 1%w/w 6 Linseed Oil BP 3%w/w
(As Preservative) 0.5%w/w
q.s. Menthol IP
In a gel base
1.0%w/w
Benzyl Alcohol IP
q.s.
(As Preservative)
In a gel base

20
 Each gm contains:- Each gm contains:-
Nadifloxacin 10mg 8 Nano Crystalline Silver 20μg
7 Mometasone IP 1mg In a gel base q.s.
Furoate 20mg
IP
Miconazole Nitrate q.s. Composition:
In cream base 10 Clotrimazole IP 1.0%
w/w
Beclomethasone IP
Composition: 0.025%
Dipropionate
w/w
Hydroquinone IP 2.0%
In a cream base
q.s.
9 Tretinoin USP 0.025%
0.10%
Mometasone IP
Furoate q.s. Composition:
1.16
In cream base Diclofenac Diethylamine BP %w/w
12 Methyl Salicylate IP 10%w/w
Composition:
Linseed Oil BP 3 %w/w
11 Clobetasol IP 0.05%w/w 5%w/w
Menthol IP
Propionate 6.0% w/w
IP q.s.
In a gel base
Salicylic Acid q.s.
In a cream base

Composition:
Composition:
14 Fluocinolone IP 0.01%w/w
13 Povidone Iodine 10%w/w Acetonide 2.0 % w/w
IP IP
q.s. Miconazole q.s.
( Available Iodine Nitrate
1.0%w/w)
In a cream base
In a water soluble
ointment base.

21
22
 PLANT LAYOUT

MANUFACTURING
TABLET
In Pharmaceutical products, there are various types of Tablets in a range of
physical appearances, from high gloss, rounded, sugar coated pieces to the
geometric, punched shaped of film coated products.
The shape, size and color are all visual characteristics reflected by the core and
the coating such as sugar coat, film coat. The shape of the core is a key factor in
the overall appearance of the Pharmaceutical tablet, not directly as a cosmetic
influence, rather as the foundation for an applied coating system.
Types of Tablets
• Sugar Coated Tablets
• Film Coated Tablets
• Soft and Hard Gelatin Capsules
Sugar Coated Tablets:
Traditional sugar coating is performed in what is generally described as a
conventional coating pan. However, the desire to reduce the time needed for the
sugar coating process has led to the trend toward side vented pans.
Sugar coating liquids used in preparing sugar coated tablets contain binders such
as Gelatin or Gum Arabic so as to increase strength of the sugar coating layer or
to increase strength between an uncoated tablet and the sugar coating layer.
Film Coated Tablets:
Film coating is the largest sector of the tablet colouring market in Pharma
Industries. Film coating techniques reduce process times, offer greater control
over coating parameters and provide more opportunity for innovation. Film
coating involves the deposition of a thin polymer layer onto the tablet core usually
by spray methods.
Soft and Hard Gelatin Capsules:
The basic difference between hard and soft gelatin encapsulation process is that
in the hard gelatin capsule process, the capsule is prefabricated and supplied
empty, whereas in the soft gelatin capsule process the encapsulation and filing
takes place simultaneously.

23
Tablet Coating Machine:
The High Efficiency Automated Tablet Coating Machine is mainly used in
pharmaceutical and food industries. It is a high efficiency, energy saving, safe
and clean equipment for film and sugar coating of tablets, pills and candies with
organic film, aqueous coating and sugar film etc.
Working:
The tablets to be coated make continuous complicated orbital motion in the closed
rotating drum under the action of a streamline of baffles. During the motion
coating medium automatically sprays according to the technological process and
rational technological parameters, at the same time hot filtered air supplied under
a negative pressure.

CAPSULE
In Pharmaceutical Industry, there are various pharma company manufactures
types of machineries for the different process and application as per there
specialty.
There are vast categories of pharma machineries as each process requires
different machineries. Such as Pharma machines for tablet filing. Machines for
tablet counting, machines for tablet pressing and machines for tablet labeling etc.
In the capsule manufacturing process first gelatin and hot demineralized water
are mixed under vacuum in gelatin melting system. After aging in stainless steel
receiving tanks the gelatin solution is transferred to stainless steel feed tanks.
Once drying is complete the pin bars enters the table section which positions the
capsule halves for striping from the pins in the automatic section. In the automatic
section capsule halves are individually stripped from the pins. The cap and body
lengths are precisely trimmed to a 0.15 mm tolerance.

24
STORAGE AREAS

Storage area should be designed or adapted to ensure good storage conditions. In

particular, they should be clean and dry and maintained within acceptable
temperature limits. Storage areas should be of sufficient capacity to allow the
orderly storage of the various categories of materials and products, namely
starting and packaging materials, intermediates, bulk and finished products,
products in quarantine and released, rejected, returned or recalled products.
Precaution must be taken to prevent unauthorized persons from entering storage
areas.
Storage Condition: Storage conditions for pharmaceutical products and
materials should be in compliance with the labeling, which is based on the results
of stability testing.
Monitoring of Storage Conditions: Recorded temperature monitoring data
should be available for review. The equipment used for monitoring should be
checked at suitable predetermined intervals and the results of such checks should
be recorded and retained.
Labeling and Containers: All materials and pharmaceutical products should be
stored in containers which do not adversely affect the quality of the materials or
product concerned and which offer adequate protection from external influences.
In some circumstances this could include bacterial contamination.
Stock Rotation and Control: Periodic stock reconciliation should be performed
by comparing the actual and recorded stocks. All significant stock discrepancies
should be investigated as a check against inadvertent mix-ups and/or incorrect
issue.

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 PACKAGING

Packaging can be defined as an economical means of providing presentation,

protection, identification, information, containment, convenience and compliance
for a product during storage, carriage, display and until the product is consumed.
Packaging must provided against climatic condition biological, physical and
chemical hazards and must be economical. The package must ensure adequate
stability of the product throughout the shelf life.
The external image of the package must not only compliment product confidence
but provide clear and concise product identification and other features included
are:
• Package should assist in patient compliance
• Package should preferably have an aesthetically
The primary packaging consists of those packaging components which have a
direct contact with the product. The main functions of the primary package are to
restrict any chemical, climatic or biological or occasionally mechanical hazards
that may cause or lead to product deterioration. Packaging must also function as
a means of drug administrations.
The packaging external to the primary package is known as the secondary
packaging. The secondary mainly provided the additional physical protection
necessary to endure the safe warehousing and for refill packaging
Material Type Examples
Glass Primary Metric medical bottle, Vial,
Ampoule
Plastic Primary & Secondary Ampoule, Vial, Infusion,
Dropper bottle & Wrapper to
contain primary Pack

Cardboard Secondary Box to contain primary pack

Paper Secondary Labels, Patient information
leaflet

Function of Packaging:
• Protective function
• Storage function
• Loading & Transport function

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MARKETS

Apple Formulations operates in domestic as well as exports markets.More than

75% of total production being exported. About 200 products are registered and
being regularly exported to various countries Afghanistan,Iraq, CIS Countries,
African Countries etc.
The main market is represent et below with the major segment:
• Exports
• Ethical Sales
• Animal Health Division
• Institutional Supplies
Approved regular supplier of medicines to Government Institutions like
Railways, Central Government Health Schemes. Major hospitals like RML
Hospital, LRS Hospital, Kalawati Saran Hospital, G.B. Pant Hospital, SVBP
Hospital Meerut, Safdarjung Hospital, Municipal Corporation of Delhi, Assam
Rifles, J&K Hospitals, Medical Stores Depot for various states like Haryana,
Himachal Pradesh, Punjab, Uttar Pradesh etc.

The company ensures the specific execution of orders to meet customer’s quality
specifications, time schedules and competitive pricingneeds.
•

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 QUALITY

At Apple Formulations we believe in “Excellence through Quality”

Apple Formulations maintains strict quality parameters for the manufacturing and
distribution of products.
We have independent Corporate Quality Assurance Department responsible for
quality affairs. Achieved head of state position through our supreme levels of
quality. We believe to deliver highest level of quality and customer satisfaction.
ISO 9001:2008 Certification and ISO / IEC 17025:2005 Accreditation explain
our efforts to achieve maximum quality level.
Quality Assurance is a measure of the degree of sophistication of managerial,
scientific and technical tools used in the plan and execution of product process of
any industry. In the pharmaceutical industry QUALITY is the most fundamental
task of Total Quality Management. We at Apple Formulations are committed to
ensure that every product we manufacture and distribute meets with and conform
over its shelf life to internationally accepted standards of quality, purity, efficacy
and safety. Apple Formulations quality focus encompasses all areas of operation
– from procurement of the best raw materials, to optimum manufacturing
technology, to precise delivery of the customer’s requirements – thus ensuring a
rapid access of both domestic and global markets. All our systems are well
documented and are implemented by an expert trained staff with a line of
reporting that is independent of manufacturing.
We have state of the art laboratory with the advanced infrastructure and
procedures to support a stringent quality policy. At our manufacturing site, the
latest analytical instruments and firmly monitored quality assurance and quality
control systems ensures consistent quality of our products. There is regular
validation of processes, test methods, water and environment, as well as periodic
calibration of all instruments, to guarantee product output of consistent top
quality. Vendor evaluation and selection is carried out as per stringent quality,
product, manufacturing, service and delivery parameters to ensure the highest
quality raw materials. The Quality Assurance Department accomplished by
qualified personnel, constantly monitors quality parameters and performing
systematic sampling and testing at every stage from raw materials, through each
process of intermediate and finished products.
A fully fledged Quality Control Laboratory which follows Good Laboratory
Practices and incorporates the most modern testing equipment, in order to
perform the stringent quality analytical tests prescribed by different national and
International Pharmacopoeia.

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FACILITIES

Apple Formulations is committed towards quality services, having distinct areas

as: Administration Area, Change Room Area, Raw Material Storage Area,
Packing Material Storage Area, Tablet Section Area, Capsule & Powder Section,
Liquid Section Area, and Finished Goods Storage Area & Quality Control Lab
Area. Apple Formulations specialize in Beta-Lactam antibiotics and have distinct
Beta-Lactam Capsules/Dry Syrup Section, located distinctively away from Non–
Beta Lactam Section.
As required by GMP & WHO standards capacity up-gradation programme is
underway, where by the output will go up even higher in the coming months.

SALIENT FEATURES:
• Upgraded to Schedule-M.
• 1ISO-9001-2008 Certified unit.
• WHO approved for Lactam group of Tablets, Capsules, Dry Syrup
and Non-Lactam Group of Compressed Tablets.
• Water treatment plant with R.O. Treatment, passing through Carbon
Bed, UV, Double Bed and Mixed Bed De-mineraliser.
• 2 conventional + ones crew type compressor along with air drier
(capacity130 CFM.)
• In-house QC department has backup for testing facilities of Govt.
Approved Commercial Test House located at short distance.
• Accorded GMP certification valid up to Nov.2011by Food and
Drugs Board Ghana.
• More than 75%of total production being exported.
• More than 6000 sq ft. of area available for expansion of
manufacturing operations.

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TRAINING CERTIFICATE

30
 MY TRAINING, EXPERIENCE AND CONLUSION

I have spent my most of training in production department which was prove to be

a medium for more knowledge providing practical aspect of Pharmaceutics.
Production mostly describes as a method where ram material is converted into a
drug.
Manufacturing of drug at a large scale takes Place using different machinery and
processes.
Machines generally used in production is based and the dosage form some of
them are as follows
• Agitators .
• Blowers
• Boilers
• Capsule equipment
• Capsule and tablet printers
• Centrifuges.
• Chillers.
• Coaters
• Cooling towers
• Dryers and Granulators
• Heat exchangers
• High Pressure Homogenizers
• Inspection machines
• Metal detectors
• Mixers
• Ovens
• Pulverizers / Cone mills
• Tablet press
• Tablet dedusted .
• Sifters
• Spray coating machines

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And some main processes are
• Dry granulation
• Powder blending
• High shear and wet granulation
• Fluid bed granulation
• Hot-melt extrusion.
• Drying.
• Pharmaceutical milling
• Compression of powder or granules into tablets
• Tablet coating equipment
• Pharmaceutical encapsulation
• Micronation

It was an opportunity for me to see the machine and manicuring process withstand
by myself in person. And I used that to hone my skills.
I learnt about all the process of making drugs from raw materials to finally
packaging of them in their pre-determined method.
Tablet, Syrups, capsules, dry syrups and different types of dosage forms their
manufacturing packaging testing was in detailed knowledge acquired by me.
It was an astonishing moment and exciting experience of expanding my practical
knowledge.
At last, I conclude by thanking all the teacher senior and the training staff who
helped me from time to time at every step.

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