An

Industrial Training Report

CONDUCTED

AT
INDUS PHARMA PRIVATE LIMITED, ALWAR

Submitted to

Northern Institute of Pharmacy & Research

Affiliated to Rajasthan University of Health Sciences, Jaipur

in the partial fulfillment of the requirements for

the award of the degree of

BACHELOR OF PHARMACY

Submitted By Under Guidance

Manish Yadav Mr. Mukesh Pilania
Enroll. No. (2020/1340) Sr. Executive
Roll No. (802380)
 DECLARATION

I “MANISH YADAV” hereby declared that I have undertaken one month Industrial Training at

“Indus Pharma Private Limited” during the period from 21/06/2024 to 22/07/2024 in partial

fulfillment of requirements for the award of degree of Bachelor of Pharmacy in the Northern

Institute of Pharmacy & Research, Alwar, affiliated to Rajasthan University of Health Sciences,

Jaipur.

Place: Alwar Signature

Date: 30/09/2024 Manish Yadav

Enrollment Number (2020/1340)

 ACKNOWLEDGEMENT

It gives me an immense pleasure to present this B. Pharmacy industrial training work and at this
moment I look back to thank all those who helped me to make this venture successful.

With deep sense of gratitude, I express my personal indebtedness and gratefulness to my guide
Mr. Mukesh Pilaniya (Sr. Executive Officer, QA Department) of Indus Pharma Private
Limited for all complete involvement throughout my work. His constant encouragement, implicit
understanding, free hand approach, valuable and painstaking fatherly gratitude was instrumental
in completing this work successfully.

My sincere gratitude and thanks to Dr. B.K. Kumawat (Principal), Mr. Anil Jangid (Assistant
Professor) Northern Institute of Pharmacy & Research, Alwar for allotting me this project work
and for guiding me throughout this work.

A, special thanks to all my friends for sharing their experiences, time and commitment especially
during finishing this internship program.

Manish Yadav
 INDEX

S. No. Content Page No.

1. INTRODUCTION OF COMPANY 1-6

1.1 Overview 1

1.2 Capability 2

1.3 Quality 2

1.4 Environment Policy 3

1.5 Marketing 4

1.6 Special Features 5

2. PRODUCTS OF THE COMPANY 7-12

2.1 Injectables 7

2.2 Liquid Orals 10

2.3 Ear/Eye Drops 11

2.4 Tablets & Capsules 11

3. PRODUCTION DEPARTMENT 13-22

3.1 Tablet Section 13

3.2 Capsule Section 16

3.3 Injectable Section 19

3.4 Syrup Section 20

4. QUALITY CONTROL DEPARTMENT 23-33

4.1 Introduction 23

4.2 Functions 23

4.3 Biological & Microbiological tests applied in Q.C. 24

4.4 Instruments 25

4.5 Control Unit 29

4.6 Batch and Continuous Operations 30

 4.7. Quality Assurance Department 31

4.8 Procedure of Quality Control 32

5. STORAGE AREA 34-35

6. PACKAGING DEPARTMENT 36-37

6.1 Introduction 38

6.2 Functions of Packaging 38

6.3 Types of Packaging 36

CONCLUSION 38

REFERENCE 39
 1. INTRODUCTION OF COMPANY
1.1 Overview
Indus established its presence in 1974 and has since maintained pace as a growth oriented
company with a presence to bc reckoned with, in injcctable and eye drops. Our focus on specialty
segtncnt in India and simultaneously establishing our presence in the intcn)ational tnarket has
auglncnted our growth and has provided ti spurt to our potential. Expott have contlibuted to a
substantial growth in total revenues.

Fig. 1.1 Company view of Indus Pharma Private Limited

Strict adherence to quality norms matching intemational standards along with competitive
pricing has provided a platfonn for the company to retain customer satisfaction and product
efficacy. Indus has specialized in the last 45 years in manufacturing more than 250 products in
small volujne liquid injections in Ampoules and Vials and eye / ear drops. Formulations of
various therapeutic areas e.g. Anti-Malarial, Anti-Inflammatory, Antibiotics, Analgesics,
Antipyretics, CoÅicosteroids, Local Anesthetics, AntiCoagulants, Anti-Emetic and Nutlitional
products are manufactured for the domestic as well as intemational markets. The Company has
about 300 workforce in its two manufactufing facilities under highly committed and experienced
management staff. Dedication of our staff in manufacturing standard quality formulations that
too in a stipulated period of time has placed Indus as major supplier for the Armed Forces
Medical Services, ESIC, PGI Chandigarh, TNMC, DHS Himachal Pradesh etc
1.2 Capability
Indus has two manufacturing facilities complying GMP and ISO 9000 certifications. The
manufacturing and quality control facility are fully equipped to manufacture

 Parenteral in vials

 Eye / Ear Drops

 Lotion (Topical Solution) in bottles

 Topical Ointment in Alluminium Tubes
 Bulk Drugs Liquid Parenteral in ampoules

 Liquid
Plant Details - Area New Delhi

Total Plot 2800 sqft

Built up Area 9600 sqft - Area Ghiloth, Rajasthan

Total Plot 107640 sqft

Built up Area 64800 sqft

Capacity single shift a day

Ampoules 12.5 million units per month

Vials 2.5 million units per month

1.3 Quality
In recognition of our role towards our employees and customers and keeping in sync with the
needs of our community, environment and nation ,we provide the best quality medicine and
services. We make optimum use of research, technology, systems, policies and practices to
ensure high standards of quality of our products.

We give a lot of importance to the quality of our API( s) forrnulatiorL The assurance of quality
standards in our product stem from the use of superior quality of raw material.
We select ISO certified manufactures with a long market standing for raw material .The raw
materials are duly put to test before being used for manufacturing products. These raw materials
are then processed in our modern plants using Inert Materials e.g. SS-316L & PP to avoid any
contamination. Manufacturing is under supervision of qualified, experienced and trained
personnel who maintain proper conditions for obtaining the desired quality.

The manufacturing process is monitored by in process controls. When the process of

manufacture is completed, the products are quarantined from where samples are drawn and
thoroughly tested. The products are finally packed, labeled and moved to finished goods store.
The Certificates of Analysis are provided to customers.

1.4 Environnmcnt Policy

Environment, Ilealth & Safety (EMS)

Our business practices are rooted in responsibility as a core value .We aim to provide our
employees with a safe and healthy work environment .We maintain sustainability by ensuring
compliance with applicable health and safety laws. The company has a holistic approach
towards understanding and managing various verticals across product life cycles. The processes
are defined keeping the importance of EHS as a corporate culture within the organization which
ensures health hazards are minimized at the time of production

Safeguarding Employees

Indus has education, training and motivation of colleagues inherent in its value statement. We
embrace employee safety programs in full compliance with legal requirement. Myriad
measures to prevent workers from succumbing to incidents/accidents and developing work
related diseases include:

 Trainings of safety beyond the premises- safety at home and road safety provided to all
employees.
 24 hrs ambulance facility for the employees and in-house dispensary to cater to
emergencies.
 Fire drill carried out each month and sufficient water tapped in fire hydrant to fight any
unfortunate fire possibility.
  Disaster management committee has been put in place to look into contingency till
help can be reached
 Basic First aid and CPR training by qualified doctor is conducted

Health & safety

Health and safety perfonnance are epitomized at Indus . We aim to achieve the highest
intemational standards in plant design, equipment selection ,and maintainance of
operations Periodic and preventive maintainance of Boilers , generators„ internal and
extemal inspections and audit are of highest quality that ensure nil discharge. The plant is
designed with Zero discharge policy and proper disposal of solid waste.

Indus has an systemized process for disposal offactory waste as listed below:

Establishment of STP/ETP for water recycling.

Complete water management to ensure zero discharge.
Rain water harvesting pit for saving and reserve ofrain water.

50% green area maintained in factory premises.

The company has an abiding concem to reduce its carbon foot print. Several voluntary
environmental initiatives include:

 More number of trees/sq meter than advised by RIICO.

 Afforestation drive
 Supports several development schemes, road passenger amenities,
road side greenery, police booths and employee economic
development amenities.

1.5 Marketing
The pharmaceutical industry in India is among significant emerging
markets for the global pharmaceutical industry. The Indian
pharmaceutical market is expected to reach $48.5 billion by 2020. It is
a seventh largest country by area and the second most populous
country (with over I .3 billion people). This is the market for our
domestic sales having unlimited scope. The range of products for
domestic markets covers various therapeutic segments e.g. Anti-
Malafial, Anti-Inflammatory, Antibiotics, Analgesic}, Anti-Pyretics,
 Conicosteroids, Local Anesthetics, Anti-Coagulants, Anti-Emetic and Nutritional
products. The market of Indus has a span of 250 formulations in almost every form e.g.
Tablets, Capsules, Liquid Orals, Injectables (Dry & Liquid), topical solutions and
ointments. The popular brands of our fonnulations includes Wintal, Trineurosol, Talnex,
Talgesic, Calmtack, Dolocare, Pmstospan, Sucroferisol, Dextrofer, Methospan, Apridex,
Becobion , Buscomol

1.6 Special Features

Some Special Features of our Factory

 Area of over 6,000 sq meters for Manufacturing, Lab, Utility & Office.

 Based on uni-flow concept with separate entries for each production area for man and
material
 Eco-friendly and agronomic design of the Building & Premises

 Latest and best in class HVAC, Water management from pre treatment purified water
and water for injection and other Utility Systems

 Complete water management with CFR 21 part 11 complaint online TOC

 Dedicated Research and development Lab
 Good lab practices GLP
 Complete Waste management and recycling as per enjoinment norms
 Good Manufacturing Process Records GMP

 Over 10,000 sq ft area dedicated for Quality Control and Quality Assurance Activities

 Canteen with FSSAI compliance

 Women's workforce of more than 50% of total strength.

 Implemented SCADA
1. with electronic signature

2. Complete Audit trail

3. All Reports in non-editable pdf formats

Our Strengths
 Experience of more than 48 years

 A dedicated and committed team of professionals

 98% of capacity of New Delhi ang Giloth plant is being exported

 The Rajasthan Plant has been set up with state of the art technology and have
approvals WHO GMP, PIC/S, TGA, Russian GMP, USFDA etc.
 Large manufacturing capacity with capability of manufacturing big batch sizes
 Small/tlial size batches are also undefiakcn for process validation and product
validation as technical expertise for technology transfer
CSR-Corporatc Social Responsibility
Indus, in its conilüitlnent to operating its business both ethically and in accordance to law

with focus on CSR across its spectmm of operation.

We endeavor to go beyond the letter of the law in our commitment towards contribution to
society.
A structured and detailed corporate social responsibility policy has been formulated to
ensure constructive activity keeping in mind the evolutionary needs of our time. We are
committed to our contribution towards building and enhanced understanding of health and
wellness of the world around us with an aim towards a holistic well-being of the society at
large and economically viable platform for natural growth.
The company policy aims at building the road map of action at the micro level leading into
the vision of sustainable growth and development at the macro level. This may include
public health and safety, employee safety ,nurturing of the environment and building
sustainable communities.
 Awareness workshops on HIV/AIDS
 Supply of free medicine to medical camps and charitable hospitals
 More than 50% women employees from top management till grass root level
 Suppon for girl child abhiyan Swatch Bharat Abhiyaan
 Blood donation camps
 Eye checkup camps
 Equal employment opportunities for physically challenged
 2. PRODUCTS OF THE COMPANY
2.1 INJECTABLES

INJECTION BRANDED
ADRENALINE Lignocaine With Adrenaline
APRICOL FORTE Monosemicarbazone
APRIDEX Dexamethasone Sodium Phos hate
ATRONEX Atro ine Sul hate
BECOBION Vit.B1,B2,Niacinamide & D-Panthenol
BUSCOMOL Hyoscine Butyl Bromide
CALMTACK Diazepam

DEXTROFER

Iron Sorbitex
Injection USP (Iron
DEXTROFER PLUS Iron Sorbitex With Folic Acid & Vit. B 12
DOLOCARE Piroxicam

EMITIL Prochlorperazine
Mesylate

NDOBOLIN Nandrolone
Phenyl propionate

INFLAWIN Diclofenac Sodium

INSTADEC Nandrolone Decanoate
KETOLIDE Ketamine 50m ml

METHOSPAN Methylergometrine
Maleate

NEOPLEX FORTE Vitamin B-Complex

Forte
NUGENTA Gentamicin Sulphate
PAXIMOL Paracetamol
PERICURE Metoclopramide
PHENAL Pheniramine Maleate
PRESTOCIN 5 Oxytocin
Carboprost
PROSTOSPAN Tromethamine
Hydroxyprogesterone
REI-UTIN DEPOT Hexanoate
RETABOLIL Arteether
Haemostatic
Inj. of N-
RIVINOL ButylAlcohol
RIVITRAX Ceftriaxone Sodium for Injection
SUCROFERISO
L Iron Sucrose
Drotaverine
SPASMONEX Hydrochloride
TALNEX Tramadol HCI

TRINEUROSOL Nicotinamide & D-Panthenol

WINTAL Pentazocin
 Table 2.2: Injections-Generic
a-ß Arteether Injection
Amikacin Sulphate Injection
Buprenophine Injection
Buprenophine Injection
Carbazochrome Injection
Carboprost Tromethamine Injection
Chloroquine Phos hate Injection
Dexamethasone
sodium
Diazepam Injection
Diclofeanc Sodium lnjection
 Table 2.3: Dry Powder Injections-Generics
Cefoperazone & Sulbactam Injection

Cefepime Injection

Cefotaxime Injection

Ceftliaxone Injection

Imipenem Injection

Meropenem Injection

Vancomycin Injection
 3. PRODUCTION OF PARENTERALS
Production team is committed to produce highest quality products, which can satisfy the
needs of both doctors and patients. The production team endeavors to manufacture
products that are cost-effective through best utilization of their resources. This department
is well equipped with latest equipment.[2-4]

Parenteral Drugs: Drugs administered by injection into a vein, muscle, or subcutaneous

tissue.

Aseptic Processing: the processes by which sterile products are filled and packaged in a
manner that maintains sterility.

Bioburden: Degree of microbial contamination or microbial load; the number of

microorganisms contaminating an object.

CGMP: Current Good Manufacturing Practices, regulatory requirements designed to

protect product SISPQ (Safety, Identity, Strength, Purity, Quality) and to maintain the
CGMP environment in a consistent State of Control, in accordance to pre-determined
Quality standards and systems.

3.1 Facilities required for parenteral production

Parenteral may contain excipients preparations such assolvents, suspending agents
buffering agents, substances to make the preparation isotonic with blood, stabilizers, or
antimicrobial preservatives. The additionof excipients should be kept to a minimum. When
excipients are used, they should not adversely affect the stability, bioavailability, safety, or
efficacy of the active ingredient(s), or cause toxicity or undue local irritation. There must
be no incompatibility between any of the components ofthe dosage form.

Water for injections is used as the vehicle for aqueous injections. It should be freshly
distilled by the process described under "Aqua pro Injection", be free from carbon dioxide,
and comply with Test for bacterial endotoxins.

Sterilization at this stage may be omitted, provided thatthe solution or preparation is

immediately sterilized upon finalization. For non:aqueous injections, fixed oils of
vegetable origin are used as vehicles. Unless otherwise specified in the individual
monograph, sodium chloride or other suitable substance(s), may be added to an aqueous
solution for injection in order to render the preparation isotonic.[5,6]
 Fig. 3.1 Overview of manufacturing process

Process Flow Diagram

Storage
Preparation Quarantine
shipping
area Aseptic area
Store filling area
room Sterilization
Clean-up
Packaging
area
finishing
Fig. 3.2 flow of materials

3.2 GMP Requirements for Sterile Products

Specific points relating to minimizing risks of
Contamination.

— Microbiological
—Particulate matter
--- Pyrogen

General Requirements

 Production in clean areas

 Airlocks for entry
  Personnel entry.
 Material entry

 Separate areas for operations

Component preparation
--Product preparation

 Filling
 Sealing etc,
 Level of cleanliness

 Filtered air

 Air classification: Grade A, B, C and D.

 Laminar air flow

— Air speed (horizontal versus vertical flow)

— Number of air changes

— Air samples

 Work station and environment

 Barrier technology and automated systems.

3.3 List of Equipments

1.) Manufacturing area

 Storage equipment for ampoules, vials bottles andclosures.

 Washing and drying equipment.
 Dust proof storage cabinet
 Water still.
 Mixing and preparation tanks or other containers.
 Mixing equipment where necessary.
 Filtering equipment.
 Hot air sterilizer.
 2. Aseptic filling and sealing rooms

1. Benches for filling and sealing.

2. Bacteriological filters.

3. Filling and sealing unit under laminar flow workstation.

3. General Room.
1. Inspection table.
2. Leak testing table.
3. Labeling and packing benches.
4. Storage of equiptnent including cold storage and refrigerators if
necessary.
An area of minimum sixty square meters partitioned into suitable sized cubicles with air lock
arrangement is recommended for the basic installation.

3.3.1 Sterile Garment Cabinet

 Made up of Stainless steel.
 Ensure a clean storage space by making use of UV disinfectant and heating through IR
lamps.
 These cabinets may be designed in horizontal airflow system and clean air through
HEPA Filters .

Fig. 3.3 Syringe Filling Machine

Characteristics

 Barrier isolators
 In-process check weighing
 Filling: rotary piston pumps.
 Volume: 0.2 to 29 ml

 All types of syringe including glass, plastic can be filled.

 Filling Rate: 300 to 600 syringes in a minute.

3.3.2 Ampoule Washing Machine

Fig. 3.4 Ampoules Washing Machine

Process

 Water is sprayed onto the ampoules.

 Turned to an angle of 180 degree with their mouthdownward to remove water.
 Finally the ampoules are filled with compressed air to remove residual water.

 Certain machines have a high temperature zone meant for killing any bacteria.

Washing cycle
1st wash -Recycled Water (WEI)

2nd wash - Compressed Air

3rd wash - DM Water

4th wash - Compressed Air

5th wash -Water for Injection (WEI)

6thwash - Compressed Air

 Fig. 3.5 Vial Filling Machine

Fill vials and bottles.

 Liquids, viscous material and suspensions and powders.

 Unique patented system for filling liquid products in sterile conditions.

 Global solution: preparation and sterilization ofcomponents, handling, sterile filling,

process control and vial laser etching.
 More than 15 years of proven reliability in sterile filling.

Process

 The machine comprises of an intake section whichloads the vials. Transferred

through an intermittent transportsection.

 Liquid filling section which fill the vials withpredetennined quantity.

 Finally the filled and rubber stoppered vials arereleased and discharged.

Main Advantages

 Vial is closed and protected throughout the process.

 Vial is opened in the final filling stage in a controlled environment with horizontal

laminar flow.

 No need for dry heat tunnel sterilization as it is carried out in an autoclave.

Sterilization and depyrogenation combined with a HWFI washing cycle and an
autoclave cycle. No need for a drug tunnel
SIP System
 For in-line sterilization of various processingequipments.
 Handling various biological solutions and mixtures requires cleaning and sterilizing these
equipments from time to time as they are susceptible to contamination.
 Proper SIP integration with pharmaceutical equipment is very important for the overall
success of the operation.

3.3.3 Types of Stcrilc Filters

Categorization Based on Size of Pores in Membrane

Filter Type Size Range Examples Of What Is Removed by
(microns) this Filter Type

Particle

10 to 200 Pollens
Particles
•
Some bacteria
•
Microfilter 0.1 to 10 • All bacteria
Yeasts
Colloids
Ultrafilter 0.001 to 0.1 Most viruses
Large organic compounds (> 10,000
Daltons
Nanofilter Less than 0.001 Small organic compounds
(Reverse Ions
Osmosis)

Microfilters

 Porosity of microfilters range mum to 10 Pifrom 0. I

 Used to remove all bacteria, yeast & colloidal forms

 Can be integrity tested
 Fig. 3.6 Microfilters
Examples: Millipore Express SHC 0.5 / 0.2 m PES filters
Fig. 3.7 Rotary Pump Aseptic Filler

Fig. 3.8 Peristaltic Filling

 Fig. 3.9 Lyophilization

3.3.4 Plungers for Syringes

3.3.5 Labelling
Labelling means a display of written, printed or graphic matter upon immediate container or the
wrapper of a drug package . The term "labelling" designates all labels and other written, printed, or
graphic matter upon an immediate container of an article or upon, or in, any package or wrapper in
which it is enclosed, except any outer shipping container.
All labels of a drug should conform as per the specifications under the Drugs and Cosmetics
Rules 1945. -- That no person sell or distribute any drug unless it is labeled in accordance with
the Rules (Rule 95 of D&C Act).
It includes information regarding indications, effects, dosage form, frequency and duration of
administration, warnings, hazards, contraindications, side effects, precautions and other relevant
information.
For identification of the product • Provide ingredients • Purpose /use of the product • Child
safety • Other information like maximum retail price(MRP), Batch No., Shelflife etc...
Legal Requirements:
 Proprietary name and established name
 Strength and dosage form.
 Quantity.
 Instructions for the use.
 Precautions & warnings.
 Manufacturing license no.
 Batch number.
 Manufacturing & Expiry date .
 The name and address of pharmaceutical industry for drugs included in the India

Pharmacopoeia.

Labelling machine -- The section has two fully automatic labelling machine manufactured by
Ambica Pharma Lab (2018) and (2010-11).
 Fig. 3.11 Plunger Rod Insertion and Labeling machine
3.3.6
3.3.6 Packing
After sealing, the bottles packed according to the company requirement.
The bottles are packed in Polythene and passed through sealing machine at 150 degree
Celsius and then they packed in the shipper/carton.
4. QUALITY CONTROL DEPARTMENT

4.1 Introduction
Quality control ensures product stability keeping the compliances to GMP going and assures that
the product will remain all their claims till they are consumed. The sample should be inspected
foe impurities, which could affect the performance or stability of the product.

The work of Q.C. people starts right from ware house till the product is delivered, although their
job is not finished after the delivery of the product because they control the sample, till it's shelf
life and it's stability is checked from time to time.

4.2 Functions

 To prepare the detailed instruction for each test and analysis.

 To release or reject.
 Each batch or raw material.
 Semi- finished product.
 Packaging and labelling material
 To evaluate the conditions under which goods are stored
 To evaluate the quality and stability of the product
 To established the revise, control procedure and specifications.
 Checking the details on the laboratory scale:
1) Pharmacopoeia status
2) Manufacture's name
3) Batch no.
4)Manufacturing date
5)Expiry date
6) Quantity
7) Container no.
 Storage conditions
 Others
4.3 Biological & Microbiological tests applied in Q.C.
 Test for potency
 Pyrogenicity
 Sterility
 Antiseptic Activity
 Antimicrobial preservative effectiveness test etc...
Stability study Lab.
Objectives
 For determination of shelf of drug product
 For inspection of physical and chemical change on storage
 For inspection of microbial growth on prolonged storage
 For inspection of therapeutic efficacy of drug
Methods
 Accelerated stability study :-
o Frequency — 1,2,3,6 month
o Temperature — 40+-2 degree Celsius
o RH- 75% +- 5%
 Intermediate stability study :
o Frequency — 3,6,9,12 month
o Temp. — 30+-2 degree Celsius
o RH – 65%+- 5%
 Long term stability :
o Frequency — 3,6,9,12,24,28 month
o Temp. - 25+-2 degree Celsius
o RH- 60%+-5%
 On goingstability :
o Frequency- 3,6,9,12,24,28,34,….month
o Temp. — 30+-2 degree Celsius
o RH – 75%+- 5%
4.4Instruments
 High Performance Liquid Chromatography
 Thin Layer Chromatography
 Gas Chromatography
 U.V. Spectrophotometer Polarimeter
 Potentiometer
 Conductivity meter
 Melting Point Apparatus
 Autoclave
 Incubators
 Humidity control
 Oven
 Titrators
 pH meter
 Digital Balance
 Water Bath
Instruments :-

1) UV spectroscopy
Manufucaturer :- Shimadzu
Model – UV - 1800

Fig; - UV SPECTROMETER
2. FTIR (fourier transform infra red spectrometer)

Manufacturer :- Piketech

Fig. 4.2 FTIR

3. Weighing machine
Manufacture ;- ANM industries

Fig ;- Analytical Weighing machine

[Link] Chromatography
Manufacturer :- Perkin Elmer

Model ;- CLARUS 680

Fig. 4.4 Gas Chromatography

5. HPLC (High Performace liquid chromatography)

Manufacturer :- Alliance
Model ;- waters e2695

Fig. 4.5 HPLC

6. Conductivity meter Manufacturer :-
Manufacturer :- Lab India
Model :- PICO+

Fig. 4.6 Conductivity meter

7. pH meter
Manufacturer :- Manti Lab Solution

Fig. 4.7 pH meter

4.5 Control Unit

Control unit it is the part of the quality control department here the sample which is being

manufactured and added in the market formulation from this one sample is placed as a control

sample as if any defect arises in the marketed sample the industry can easily analysethat defect

with the help of that control sample. The control unit helps in analyzing the problem arising in

the marketed formulation.

 4.6 Batch and Continuous Operations

Batch Operations Continuous Operations

Raw material is fed in one lot Raw material is fed continuously

Apparatus is ideal during charging Apparatus is never ideal during

Id discharging Charging and discharging

Requires more labour Do not requires more labour

Rate of reaction does not remain Rate of reaction remain

Constant Constant

Require more energy Require less energy

Quality control is difficult Quality control is obtained

Less profitable More profitable

 4.7. Quality Assurance
Department

4.7.1 Introduction
Quality Assurance (QA) means that products used by consumers should fulfil the need for which
it was acquired. To achieve this end, a whole gamut of organizations, methods and efforts are
required. The whole process of assuring, that the quality of the product will be as stated or
perceived, consistently, can be called quality assurance.

4.7.2 In-process control

The In-Process Control (IPC) is the checks made during the course of manufacture which
aims to ensure that product will comply with its specifications and when the finished product
 Contains the correct ingredients in the correct proportions.
 Bears the correct label (or is otherwise suitably marked or identified) and
 Is stored and distributed so that its quality is maintained.
Quality of a product can never be inspected into the product. It must be built into the product
during manufacturing

Validation may be defined as a means to prove that an equipment or process actually performs
as per design or requirement. This is achieved by measuring any attribute that is possible to
quantify.

4.7.3 Purpose of Validation

Validation is carried out to have better control of the manufacturing and related operations to

ensure minimum deviations in actual production from the ones required by design. The benefit of

such validation exercises therefore include better system control and maintainance and a high

degree of assurance that a specific process will consistently produce meeting its predetermined

specifications and quality characteristics.

 4.8 Procedure of Quality Control

Steps involved in are-

 Raw material analysis

After receding raw material in store division. Q.C. dept is called for sampling for testing its
quality & purity as per pharmacopoeia. If the raw material stood in its Q.C. passes the raw
material for production for inspections two samples from each of the tablet, capsule, and liquid
section are selected, one is meant for testing and another is for storage.

 In process control

There is a real and significant difference between a finished product and the quality
assurance of the manufacturing process.

There are many equipment used in each section for testing during the in process are-

l. Electronic balance
2. venire calipers
3. Measuring cylinders

Description - Describe physical property of sample as color, odor, and physical state.

Solubility - Maximum amount of solute dissolve in minimum quantity of solvent.

Identification - Conformation about sample.

Color & color of solution - Substances give specific color in presence of reagent specified in

I.P

Limit test - Quantitative and semi qualitative determination of elements present in sample.

Loss on drying - Rare observed water or water of hydration is determined by specified

condition.

Titration -Tetrad and torrent are used in titration in standardization of solution.

Assay - To determine actual quantity of active ingredient present in sample.

Stability data generation and handling

HPLC- In the past few years, stability testing has been revolutionized by too highly technologic
advancement -high pressure liquid chromatography (HPLC) methodology, and the computer for
stability data acquisition, storage, and analysis and repotting.

Method used for checking the quality

1. Electrical method

It is a tetrameter method that can be used for the precise analysis of active ingredients.

2. Solvent extraction method

It is possible to extract acidic, neutral, of basic compounds from organic solvent on the basis
ofpartial behaviors of their ionized and unionized species.

[Link] photometric Method-

This methods is widely used in pharmaceuticals for this material is separated by the solvent and
than it's put in the spectrophotometer and observations taken

[Link] method
Now days TLC is replaced by HPLC and rarely used in Medicament Biotech Ltd.

Test for water This test is done to determined quantity ofmoisture/water present in

Sample. Determined by KARL FISHER titrimetric method.

5. Quality assurance control

The concept of quality control refers to the process of staffing to produce a perfect product by a
series of measures requiring an organized effort at every stage in production. Quality control
ensures product stability keeping the compliance to GMP going and assures that the product will
retain all there claims till they are consumed.
 5. STORAGE AREA
The Store House is mainly divided into 2 sections :-

 Store house for raw materials

 Store house for finished goods
In the raw material store house, there are broadly 3 types of raw materials :-

1. Those raw material used for formulation of the product, is stored in four divided area.
 Storage area for received materials
 Storage area for materials under testing
 Storage area for approved materials
 Storage area for rejected materials
2. Those raw materials used for packing of the product.
3. Stationary
There's a separate area (Quarantine) for temporarily storing the raw materials before the Q.C.
approves them.

Function of the store department :-

To efficiently requisition material and store and to see that the stock of no item is allowed
either to fall below the prescribed minimum level or to go above the fixed maximum quantity

1. To carefully examine all goods and material on receipt and to arrange for a systematic and
efficient storing of the same.
2. To see the accurate and promote distribution of all items to the factory department as
required under issue requisition notes.
3. To maintain efficient quantity records of movelnents of stocks and to account for all
goods that have come in to their charge.

4. To prevent any theft wastage or deterioration of stock.

5. Each container or group of containers is visually checked by store keeper for correct
labelling, damage, broken seals or contamination and verified against the appropriate
purchase order.
 After initial inspection to all container received, 'Under test' labels are affixed by the
receiving clerk.
 These labels contain all information contained in the Receiving record.
 These containers are then place in a segregated area under quarantine.
 These issued the required sample for the test to quality control department.
 If the sample is fail i.e. not as standard than the rejected sample was placed in the rejected
side with rejected label.
 If the sample is pass then placed in the ready to use side with approved label.
 6. PACKAGING
DEPARTMENT

6.1 Introduction
Packaging department is responsible for secure and attractive packing of various formulation.
Packaging is the science, art and technology of enclosing or protecting products for distribution,
storage, sale, and use. Packaging also refers to the process of design, evaluation, and production
of packages. Pharmaceutical packaging can be defined as the economical means of providing
presentation, protection, identification , information, convenience ,compliance , integrity and
stability of the product .

6.2 Functions of Packaging

 Product Identification:- Packaging greatly helps in identification of products.

Product Protection:- Packaging protects the contents of a product from spoilage,
breakage, leakage, etc.
 Facilitating the use of product:- Packaging should be convenience to open, handle
and use for the consumers.
 Product Promotion:- Packaging is also used for promotional and attracting the
attention of the people while purchasing.
6.3 Types of Packaging
4. Primary packaging- is the material that first envelops the product and hold it. This
usually is the smallest unit of distribution or use. Ex. Aerosol spray can, blister packs,
bottle
5. Secondary packaging — Is outside the primary packaging perhaps used to group primary
package together. Ex. Boxes, cartons
6. Tertiary packaging- is used to bulk handling and shipping. Ex. Barrel, container, edge
protector
Package Testing:
 Drop test
 Vibration test
 Shock test
 Inclined impact test
 Revolving drum test
Liquid oral packaging machine :-
 Pharma Lab monoblock filling and sealing machine
 Phama Lab linear filling machine
 Ambica Pharma Fully Automatic Labelling machine

Parenteral (vials and ampoules) packaging machine :

 EL Mach 3015 Blister machine
o Forming— 140-160 degree Celsius
o Sealing— 160-180 degree Celsius
 CONCLUSION
Involving the class at all stages of industrial training motivates the students and helps to take full
advantage of all learning opportunities presented. It also brings dimension to student's education, which
cannot be gained in the class room as well as helping to make connection between the different aspects of
educational experience.

During my training schedule, I have gone through various department of the company and

find that company follow the latest CGMP and also meet the environment norms.

During my industrial training in Axa Parenterals. I learned different things about the pharmaceutical
industry. I came to know about functioning of different instruments used in the pharmaceutical company.

I came to the conclusion that the company is prospering very well and is taking itself to new heights. I
had a nice experience in this company.

On the whole, the company members work like family members and support each other. We are thankful
and wishes the best for the welfare and letter achievement along with every worker of this company.
 REFERENCE
 [Link]
 Cakir, 0., Yardimeden, A., & Ozben, T. (2007). Chemical machining. Archives of Materials
Science and Engineering, 28(8), 499-502.
 Langworthy, M. (1994). Chemical Milling By Nontraditional machining process.

Machining ASM Handbook.

 Tehrani, A. F., & Imanian, E. (2004). A new etchant for the chemical machining of St304.
Journal of materials processing technology, 149(1-3), 404-408.

 Allen L. V and Ansel H. C. (2014). Ansel's Pharmaceutical Dosage Forms and Drug Delivery
Systems. Philadelphia: Lipincott Williams and Wilkins.

 Jones D. (2008). Fasttrack Pharmaceutics Dosage Form and Design. London: Pharmaceutical
Press.

 Lachman, L., Lieberman, H. A., and Kanig, J. L. (1986 ), The Theory and Practice of Industrial
Pharmacy, 3rd ed. , Philadelphia: Lea & Febiger.

 Lockhart, H and Paine, F. (1996). Packaging of Pharmaceuticals and Healthcare Products.

Dordrecht: Springer Science + Business Media.

 Ofoefule, S. I. (2002). Textbook of Pharmaceutical Technology and Industrial

Pharmacy. Nigeria: Samakin (Nig) Enterprise.

 sakr, A. A and Alanazi, F. K (2012). Oral Solid Dosage Form. In L.A Felton (Eds.),
Remington Essentials of Pharmaceutics (pp. 581-610). London: Pharmaceutical Press.

 Shayne C. G. (2008), Pharmaceutical Manufacturing Handbook Production and

Processes. New Jersey: John Wiley & Sons, Inc.

 Allen L. V and Ansel I-I. C. (2014). Ansel's Phamaceutical Dosage Forms and Drug
Delivery Systems. Philadelphia: Lipincott Williams and Wilkins.

 Dash, A. (2014). Solid Dosage Foms. In A. Dash, S. Singh and J. Tolman (Eds),
Pharmaceutics: Basic Principles and Application to Pharmacy. (pp. 161-180 ). USA:
Elsevier Inc.

 Jones D. (2008). Fasttrack Pharmaceutics -- Dosage Fom and Design. London:

Pharmaceutical Press.