RAHUL CHAUDHARY INDUSTRIAL TRAINING REPORT.docx

1 | P a g e R V I N S T I T U T E O F P H A R M A C Y , B I J N O R
INDUSTRIAL TRAINING REPORT
A
Report
In Partial Fulfillment
of
BACHELOR OF PHARMACY
By
RAHUL VERMA
ROLL NO. 2011690500044
Under the supervision of
Dr. Hitesh Kumar
Director
To the
R V INSTITUTE OF PHARMACY, BIJNOR
(Sudheshana Education Charitable Society, Bijnor
Moradabad Road, Bijnor UP-246728)
May, 2023

CERTIFICATE
This is to certify that Mr.Rahul Verma, Student of R V Institute of Pharmacy,
Bijnor has been completed industrial training in Evaron Pharmaceuticals,
Address: Plot No.F3.Industrial Area. Bahadrabad (U.K). At during the period,
01 Feb 2023 To 03 Mar 2023.
This work is done originally by students under my Supervision.
The industrial training was enriched with the knowledge & working culture of the
respective company.
SUPERVISOR
DR. HITESH KUMAR
Director
R V Institute of Pharmacy
………………………………………………
EXTERNAL EXAMINER

ACKNOWLEDGEMENT
I am very thankful to Mr. Vishvjeet Yadav Plant Head of Evaron
Pharmaceuticals (U.K). Pharmaceutical Company for giving me permission and
providing all the essential facilities which were required for the training.
I want to give a thanks to HOD of Quality Assurance Mr. Lokesh singh, HOD of
Raw Material Mrs. Yashoda Rawat, HOD of Quality Control Mrs. Deepika
Rana and HOD of production Mr. Madhusudan Sharma who supervised me for
training work.
A special thanks to all staff members who co-operate me during the training
period.
I have clean information about every instrument, manufacturing procedure and
analytical methods.
Thank you
Rahul Verma
B. Pharm. (IIIrd
Year)
Roll no. 2011690500044

CONTENT
Sr. No. Content Page No.
1. Introduction 1-2
2. Industrial Training Certificate 3
3. Quality Assurance 4-5
4. Raw Material 6-8
5. Quality Control 9-10
6. Tablet Section 11-13
7. Granulation 14-19
8. Compression 20
9. Coating 21-22
10. Capsule Section 23
11. Packaging Section 24-25
12. Conclusion 26

INTRODUCTION
Evaron Pharmaceuticals
Address: Plot No.F3.Industrial Area. Bahadrabad (U.K).
Evaron Pharmaceuticals is a fully integrated developer, manufacturer and marketer
of broad range of soft gelatin formulations with a strong regulatory and
infrastructure back end to support its r&d and growth strategy in global markets.
Evaron Pharmaceuticals exclusively develops and deals only with soft gelatin
formulations over the last 4 decades and currently operates 3 state-of-the-art
manufacturing sites in India with approvals ranging from who GMP to US FDA
and ISO certification for quality, environment and occupational health and safety.
Evaron Pharmaceuticals also stands approved by the cu health and sanitary
authority for exports to eu and allied nations.
Evaron Pharmaceuticals is the ideal of source of soft gelatin formulations from
India the world due to flexibilities with olive's business model manufacturing
capabilities in terms of low volume and high volume requirements with strong
technical support alongside the competitive edge that it inherits by virtue of its
sourcing and procurement strength for global markets.

VISION AND MISSION
Vision: "To be a global pharmaceutical company with increasing focus on
innovative research and developed markets."
Mission: "A Reliable source of Quality Healthcare products that safeguard Life
and Health over the world." The business is focused around the delivery of three
strategic priorities which aim to increase growth, reduce risk and improve our
long-term financial performance. These priorities are: grow a balanced global
business, deliver more products of value, and simplify the operating model.
To fulfill this goal, we seek to achieve excellence in:
 Dedicated Research and Development in the field of soft gels.
 Manufacturing expertise alongside a state-of-the-art facility.
 Maintenance of globally benchmarked quality and regulatory standards.
 Customer satisfaction through delivery of products and services with an
organized approach.
 Creating and sustaining a professional environment conducive to learning
and human resource development.

CERTIFICATE OF INDUSTRIAL TRAINING

QUALITY ASSURANCE
There are some points for quality assurance:-
 Quality Assurance is the sum total of the organized arrangements with the
objective of ensuring that products will be of the quality required for their
intended use.
 Quality management in pharmaceutical industry is important because identity,
purity, safety and quality of product strongly essential in pharmaceutical field.
 Good Manufacturing Practices (GMP) is that part of quality assurance aimed at
ensuring that products are consistently manufactured to a quality appropriate to
their intended use.
 Quality Assurance skills are useful in any role because they help you provide a
high-quality product or service.
 It is a critical task in any work place, quality assurance refers to the method by
which the company ensures the integrity of its product or service.
 Its check the workflow process, where every employee is responsible for
ensuring the quality of the product.
 QA department maintain the all types of documents related to the industry like-
product sample, Batch Manufacturing Record (BMR), Batch Product Record
(BPR) etc.
 QA check it all the departments document.
1. How to write Standard Operating Procedure (SOP):-
 SOP describes standard SOP format that you can use immediately for your
quality procedure.
 SOP has instructions on how to write a formal operating procedure for your
systems which you can follow every day.
2. Quality Documentation Management and Change Control:-
 This SOP describes how to generate new quality documents or change control
of existing documents, review of quality documents, satellite file management,

and role of document author, approver, document control officer and satellite
file administrator.
3. Documentation Rule for GMP Documents:-
 This SOP describes the principles to be followed in GMP documents, entry of
data and information, signature requirements and correction technique of
incorrectly entered data or information.
4. Quality Documentation-Control, Tracking and Distribution:-
 In this SOP you will find mainly the role of document control officer during the
initiation, creation, circulation and approval of new quality related documents.
 Management of existing and superseded documents is also a part of this
procedure.
 It also describes the procedure of modification and review of existing document
using a documentation database.
 You will see all the forms referred during the instruction are attached at the end
of the procedure.
5. Shelf Life of Product:-
 This simple SOP describes the meaning of shelf life and provides on how to
interpret shelf life and storage conditions for your raw materials from the
Certificate of Analysis, determining expiry date for your finished products by
use of raw material date of manufacturing and their shelf life.

RAW MATERIAL
Raw Material (RM) is defined as the starting material used in manufacturing of
finished product.
Purchase specification for raw material:-
Regarding purchasing of raw materials following points should be considered:
 Cost of raw material.
 Quantity, purity and quality of raw material.
 Vendor selection: Materials should be purchased and sourced only from
approved suppliers and manufacturers. Choice of vendor should be primarily
based on quality consideration and Supplier/Manufacturer of the material
should have his name listed in companies approved vendors list.
 All raw materials should be checked for following things:
 Name of the manufacturer/ supplier.
 Name of the product/material.
 Batch numbers.
 Date of manufacture and date of expiry.
 Quantity received and number of containers or packages.
 Condition of containers and materials.
Maintenance of store for raw material:-
 There should be a sufficient area/ Capacity for the storage of raw materials.
 The area used for storage of raw materials should be clean, dry and maintained
within acceptable limits of environmental conditions.
 There should be a well equipped and appropriately designed reception area for
receipt of raw materials.
 There should be a Separate area for sampling.
 There should be separate areas for storage of rejected, returned material.
 There should be a separate Safe and secure area for storage of narcotics,
psychotropic, hormones, steroids, highly active and dangerous material.
 There should be a separate area for in-process materials.
Storage condition:-

The raw materials in the store should be stored according to its storage conditions
required: For example:
 For general product:- Room temperature should be 30◦C and Relative
humidity should be 60%.
 Products requiring storage in air conditioning (Temperature should be 25± 2◦C
& Relative humidity should be 45 to 55%).
 Products requiring Low temperature storage (Temperature should be 2 to 8◦C).
 Separate area for sterile product storage in AC under sterile conditions.
 Light sensitive material in amber color container.
Labelling of raw material:-
 Designated name of product and code
 Batch no. given by supplier
 Name of supplier and manufacturer
 Quantity of product
 Mfg. date and Exp. Date
 Type of product
Completed after all process take the sample by QC in presence of QA for testing
of raw material.
Type pharmaceutical raw materials:-
Generally, Pharmaceutical raw materials can be categorized into three categories:-
(a) Active Pharmaceutical Ingredients (APIs)
(b)Inactive Ingredients or Excipients
(c) Packaging Raw Materials
(a) Active Pharmaceutical Ingredients (APIs):-
API is one of the main parts of the pharma drug which is pharmaceutically active
and is responsible for the drug action. Accuracy and Precision with the raw
materials are two main must aspects for while making API.
Strengths of APIs:- There are certain standards to determine APIs strength in each
drug. Manufacturers are required by the FDA to approve their products potency in
labs as well as in real life through patients.

(b) Inactive Ingredients or Excipients:-
Excipients also called as inactive ingredients or drug carriers. Pharma raw
materials used as excipients consist of solvents and other such carriers. Excipients
bring bulkiness and stability in the drug formulation, along with facilitating
absorption and preventing denaturation of drugs.
(c) Packaging Raw Materials:-
Packaging in the pharmaceutical industry also need to be perfect and precise. Raw
materials used for packaging in the pharmaceutical industry includes plastics,
polymer, glass, aluminum foil, paper and more. Packaging is made a separate
category for the pharma because of the use of diversified raw materials.

QUALITY CONTROL
Quality Control (QC) is the part of GMP concerned with sampling, specification &
testing, documentation & release procedures which ensure that the necessary &
relevant tests are performed & the product is released for use only after
ascertaining its quality.
1. Quality control sampling section:-
 To draw the sample of Raw Material (RM) from store.
 To draw the samples of Finish Product from production department.
 To keep control sample for reference & for stability studies.
 Final inspection of each batch.
2. Quality control chemical section:-
 Complete analysis of all RM/ process & FP sample as per prescribed standard.
 To send report to production, store, QC office.
 To carry out stability testing etc.
 Instrument maintenance and calibration.
4. Quality control office:-
 To make certificate of analysis of R.M. &finished products.
 To maintain & keep records of analysis & certificate of analysis.
Some Instruments name used in the QC:-
1. Digital weighing balance
2. Moisture analyser
3. Tablet friability test apparatus
4. Digital PH meter
5. Desiccator (for working standard)
6. Vaccum oven
7. Tablet dissolution test apparatus (USP standard)
8. Digital tablet disintegration test apparatus
9. Magnet stirrer

10.Sonicator
11.Muffle furnace
12.Hot air oven
13.Tablet hardness Tester (Fizer hardness tester)
14.UV spectroscopy
15.HPLC chromatography
Digital weighing balance Tablet friability test apparatus
Tablet dissolution test apparatus

TABLET SECTION
Tablet:-
A tablet is a pharmaceutical oral dosage form or solid unit dosage form. Tablets
may be defined as the solid unit dosage form of medication with suitable
excipients. It comprises a mixture of active substances and excipients, usually in
powder form, that are pressed or compacted into a solid dose.
Advantage:-
 Production aspect
 Large scale production at lowest cost
 Easiest and cheapest to package and ship
 High stability
 User aspect (doctor, pharmacist, patient)
 Easy to handling
 Lightest and most compact
 Greatest dose precision & least content variability
 Coating can mark unpleasant tastes & improve pt. acceptability
Disadvantages:-
 Some drugs resist compression into dense compacts.
 Drugs with poor wetting, slow dissolution, intermediate to large dosages may
be difficult or impossible to formulate and manufacture as a tablet that provide
adequate or full drug bioavailability.
 Bitter taste drugs, drugs with an objectionable odor, or sensitive to oxygen or
moisture may require encapsulation or entrapment prior to compression or the
tablets may require coming.

Classification of tablets:-
There are many types of tablets according to their uses route of administration and
manufacturing process-
 Tablet ingested orally:-
 Compressed tablet
 Multiple compressed tablet
 Enteric coated tablet
 Sugar coated tablet
 Film coated tablet
 Chewable tablet
 Tablet used in oral cavity:-
 Buccal cavity tablet
 Sublingual tablet
 Lozenges
 Dental cone
 Tablet by their route of administration:-
 Implantation tablet
 Vaginal tablet
 Tablets used to prepare solution:-
 Hypodermine tablet
 Disperiable tablet
 Effervescent tablet
 Tablet triturator

Evaluation of tablets:-
 Appearance
 Content of active ingredient in the tablets
 Uniformity of weight
 Size and shape
 Organoleptic properties
 Hardness and friability test
 Disintegration test
 Dissolution.
Tablets

GRANULATION
Granulation, a technique of particle enlargement by agglomeration, is one of the
most significant unit operations in the production of pharmaceutical dosage forms,
mostly tablets and capsules. During the granulation process, small fine or coarse
particles are converted into large agglomerates called granules.
Ingredients used in formulations of tablet:-
1. Drugs (APIs)
2. Fillers, diluents, bulking agent
 To make a reasonably increases size of tablet.
Examples:- Starch, Anhydrous lactose, Microcrystalline cellulose
3. Binders
 To bind powders together in the wet granulation process.
 To bind granule together during compression.
Example:- Gum acacia, Tragacanth
4. Lubricants
 To reduce the during friction tablet ejection between the walls of the tablet and
the walls of the die cavity.
Example:- Stearic acid, Magnesium stearate, Mineral oil
5. Disintegrates
 To promote breakup of the tablets.
 To promote rapid release of the drug.
Example:- Explotab
6. Glidants
 Reducing friction between the particles.
 To improve the flow properties of the particles.

Examples:- Silica, Magnesium stearate
7. Antiadherents
 To prevent adherence of the granules to the punch faces and dies.
Examples:- Silicon dioxide, Calcium silicate
8. Antioxidants
 Its used for the safe to microbes.
Examples:- Carotenoids, Selenium, Vitamins C and E
9. Preservatives
 Its used for the preserve to long time.
Examples:- Methylparaben (methylhydroxybenzoate), Potassium sorbate, Sodium
benzoate
10. Flavoring agents
Its used for maintain the taste and smell.
Example:-
Methods of granulation:-
There are three method of granulation:-
(a) Direct compression
(b) Dry granulation
(c) Wet granulation
(a) Direct compression:-
 Tablets are compressed directly from powder blends of the active ingredient
and suitable excipients.
 Takes and add the all ingredients and mix through the blinder and compress by
the compression machine to powder and make the tablets.
 No pretreatment of the powder blends by wet or dry granulation procedures is
necessary.

(b)Dry granulation:-
This process is used when the product needed to be granulated may be sensitive to
moisture and heat. Dry granulation can be conducted on a press using slugging
tooling or on a roller compactor commonly refered to as a chilsonator. Dry
granulation equipment offers a wide range of pressure and roll types to attain
proper densification. However, the process may require repeated compaction steps
to attain the proper granule end point.

(c)Wet granulation:-
Wet granulation is a process of using a liquid binder or adhesive to the powder
mixture. The amount of liquid can be properly managed, and over wetting will
cause the granules to be too hard and under wetting will cause the granules to be
too soft and friable. Aqueous solutions have the advantage of being safer to deal
with than solvents.

Blender:-
 Powders to be used for encapsulation or to be granulated must be well blended
to ensure good drug distribution.
 Inadequate blending at this stage could result in discrete portion of the batch
being either high or low in potency.
 Steps should also be taken to ensure that all the ingredients are free of lumps
and agglomerates.
 For these reasons, screening and/or milling of the ingredients usually makes the
process more reliable and reproducible.
Cone blender

Sieving:-
Separation of a mixture of various-sized particles, either dry or suspended in a
liquid, into two or more portions, by passing through screens of specified mesh
sizes.
Dryer:-
Dryer used in the pharmaceutical industry for the dry of wet granules to the
powder.
Fluid bed dryer

COMPRESSION
 The powder filled in the hopper.
 The powder transfered through the hopper into the die.
 Dies produce the sufficient weight, size and shape of the tablet.
 Powder flow can be improved mechanically by the use of vibrators, incorporate
the Glidants.
 The property of forming a stable, intact compact mass when pressure is applied.
 Punches for compressing the granulation within the dies.
 Cam tracks for guiding the movement of the punches.
 Feeding mechanisms for moving granulation from the hopper into the dies.
20 Compression 27 Compression

COATING
Objectives:-
 To makes the taste, odor, or color of the drug.
 To provide physical and chemical protection for the drug.
 To control the release of the drug from the tablet.
 To protect the drug from the gastric environment of the stomach with an
acid resistant enteric coating.
Type of coating:-
1. Film coating
2. Sugar coating
3 Enteric coating
Pan coater

Coating Material:-
(a) Polymer used in film coating:-
 Cellulose derivatives.
 Methacrylate amino ester copolymers.
(b) Plasticizer used in film coating:-
 Polyols Polyethylene glycol 400.
 Organic esters - diethyl phthalate.
 Oils/glycerides - fractional coconut oil.
(c) Colorants used in film coating Iron oxide pigments:-
 Titanium dioxide.
 Aluminium lakes.
Water insoluble pigments are more favourable than water soluble colours for
the following reasons:-
 Better chemically stability in light.
 Optimised impermeability to water vapour.
 Better opacity
 Better covering ability.
Coating Problems:-
1. Picking /chipping.
2. Roughness.
3. Sticking
4. Film cracking/peeling.
5. Mottling:

CAPSULE SECTION
Capsule:-
Capsule is solid dosage forms which is patient takes the oral routes
Filling Hard Capsules Shells:-
 With empty capsule in the loader tray, the tray placed on top of the filler unit.
 The loader inserts the capsules into the filling unit and is removed, and the top
plate is lifted to separate the caps from the bodies.
 The powder is placed on the unit and the capsule bodies filled.
 The top plate is returned to the unit and the caps placed on filled capsule bodies.
Process Capsule Filling:-
1. Milling /Sieving of all Ingredients.
2. Blending Powder Blender/Empty Capsules.
3. Capsule Filler.
4. Capsule cleaner.
5. Capsule injection screen.
6. Capsule check-weighing system/reject.
7. Finished capsules.
Capsule section

PACKAGING SECTION
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. Package labeling or labeling is any
written, electronic, or graphic communications on the packaging or on a separate
but associated label.
Types of packaging:-
There are two types of packaging:-
1. Primary packaging.
2. Secondary packaging.
1. Primary packaging:-
It is the packing which is in contact with medicament (capsule or tablet).
(a) Blister packaging:-
 In this PVC and Al Foil is used for packaging
 Sometimes Al foil is used wholly for packaging
 The blister package is formed by heat- softening a sheet of thermoplastic resin
and vacuum drawing the softened sheet of plastic into a contoured mold.
Blister packaging machine consist of-
 Feeder (vibrator).
 A guide track.
 A forming dies.
 Forming heater
 Sealing heater.
 Printing registration controller
 Cutter
(b) Strip packaging:-

The strip package is form by feeding to webs of a heat sealable flexible film
through either a heated crimping roller or a heated reciprocating platen. In this the
product is drop into the pocket formed prior to forming the final set of seals.
2-Secondary Packaging:-
It is the packaging which is in contact with the primary packaging.
It involved-
 Cartoons (printed)
 Corrugated boxes (CB)
 White board box
 Ceeper
Packaging

CONCLUSION
Evaron Pharmaceuticals helped me to imbibe the detailed information about
Tablet section, Capsule section & Packaging section.
This industrial training provided a valuable learning experience in the carrier
exploration process and gave us unexpected benefit. Now I have evaluated the
class room taught facts and ideas and applied them to the real life situation. We
came to know about many things such as the GMP (Good Manufacturing
Practices). The Current Good Manufacturing Practices (cGMP) the basic
laboratory requirement for product validation. The variety of machine used in the
large scale industries of medicine etc.
These are many other factors which enhance my knowledge and have created a
lifelong interest to learning through an exposure to new educational experience.
…. A Report By
Rahul Verma
B.Pharm IIIrd
Year
Roll No- 2011690500044

THANK YOU

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