A Report File on

―INDUSTRIAL TRAINING‖
In Partial Fulfillment for the award of the
Degree of

BACHELOR OF PHARMACY

Submitted by:

DEEPANSHU BAISLA

Roll No. 2110770500017

Under the Guidance

Of

Mr. Rahul Sharma

Assistant Professor

Lakhmi Chand Patwari College Of Pharmacy

Dr. APJ Abdul Kalam Technical University, Lucknow

Uttar Pradesh

SESSION 2023-24
 Lakhmi Chand Patwari College Of Pharmacy, Khekra

CONTENT

1. Certificate

1.1. 2. Acknowledgement

3. Preface

4. Objective of Industry Training

5. List of Abbreviation

6. Introduction about Industry

7. Company Organization

8. Working of a pharmaceutical industry

9. Quality Control

10. Raw material storage area

11. Production area

12. Declaration

13. Conclusion
CERTIFICATE
It is to Certified that Deepanshu S/O Babli Bansal has carried out the report on
―Industrial Training‖ under the supervision of Mr. RAHUL SHARMA, Assistant
Professor, Axis Institute of Pharmacy, Kanpur. The report embodies result of original work
and studies are carried out by the student himself and the content of report do not form the
basis for the award of any other degree to the candidate or to anybody else from this or any
other University/Institution.

Mr. Rahul Sharma

Assistant professor

Lakhmi Chand Patwari College of Pharmacy, Khekra

 Lakhmi Chand Patwari College of Pharmacy, Khekra

2. ACKNOWLEDGEMENT
Every mature individual in professional life is keenly aware of his sense of ineptness to
many people who have stimulated and influenced his intellectual development. Ordinarily,
this feeling is expressed in customary gesture of acknowledgement. Therefore, it seen as a
right to acknowledge my gratitude with sense of veneration to the Almighty GOD and
various people who helped me during the course of Industrial training. Their valuable
guidance and wise direction have enabled me to complete my practical training. Their
valuable guidance and wise direction have enabled me to complete my practical training in
systematic and smooth manner.
I am also quite thankful to Dr. SHAMIM, HOD, Lakhmi Chand Patwari College of Pharmacy,
Khekra who give opportunity to do training at BADRIVAS BIOTECH Pvt. Ltd.

I am also quite thankful to Mr. Rahul Sharma, Assistant Professor, L.C.P COLLEGE of
Pharmacy who guide me during my training at BADRIVAS BIOTECH Pvt. Ltd.
I am also thankful to me to be a part of training and completing it successfully.
I am also thankful all towards all other technical staff for giving their advice during training.
Thanking you !
Deepanshu Baisla
B.Pharm IIIrd Year
Roll No. 2110770500017
 Lakhmi Chand Patwari College of Pharmacy, Khekra

3. PREFACE

Pharmacy is a profession which is concerned with the art and science of preparing suitable
and convenient material for distribution and use in the treatment and prevention of disease,
so it is a fully technical profession where practical knowledge is much more important along
with theoretical knowledge.

According to curriculum of a Third year (Sixth Semester) integrated degree course of

BACHELOR OF PHARMACY each student has to undergo practical training for a period
of one month in any of the pharmaceutical industry in India.

I was directed to undergo at ―ANG Lifesciences Pvt. Ltd.‖ and this report contains a brief
description of the above pharmaceutical industry which was observed during the training
program.

The report is based on knowledge of topic relevant for the projects and discussions with the
inbound & outbound department in charges, and survey of the company.

The project is divided into five sections to simplify and distinguish the topic from each
other’s.

During the project, I have concluded some analysis which is mentioned after each sub
topics
 4. OBJECTIVES OF INDUSTRIAL TRAINING

The purpose of Industrial Training is to expose students to real work of environment experience and at the same
time, to gain the knowledge through hands on observation and job execution. From the industrial training, the
students will also develop skills in work ethics, communication, management and others. Moreover, this
practical training program allows students to relate theoretical knowledge with its application in the
manufacturing industry.

1. To enable the student to relate the theoretical knowledge acquired in class with the practical skills and
actual work on site.
2. To provide an opportunity to students to incorporate the principals and techniques theoretically learnt
into real life problem solving situations.
3. To identify and solve problems on site.
4. To develop positive attitude towards work.
5. To acquire good technical writing skills.
6. To develop interpersonal and communication skills in associating with staff and people from different
background.
7. To expose students to pharmacy ethics and codes of practice.
8. To enable us acquire supervision skills and control of projects to ensure that the work being done is of
good quality.
9. Students will be able to apply the skill that they have gained throughout their academic years.
10. In addition , they can enhance their knowledge & abilities at the companies that they are attached to.
11. To provide students the opportunity to test their interest in a particular career before permanent
commitments are made.
12. To develop skills in the application of theory to practical work situations.
13. To develop skills and techniques directly application to their careers.
14. Internships will increase a student's sense of responsibility and good work habits.
15. To expose students to real work environment experience gain knowledge in writing report in
technical works/projects.
16. Internships students will have higher levels of academic performance.
17. Internships program will increase student earning potential upon graduation.
18. To build the strength, teamwork spirit and self-confidence in students life.
19. To enhance the ability to improve students creativity skills and sharing idea.
20. To build a good communication skill with group of workers and learn to learn proper .
 8. WORKING OF A PHARMACEUTICAL INDUSTRY
Pharmaceutical Industry : A Pharmaceutical Industry is an industry where life saving drugs is prepared
with excessive care and standards. So it is very different from other industries.
8.1. Cycle of Formulation Unit :
1. Plant Development :
• Plant and Premises
a) Location and Surrounding
b) Water Supply
c) Sewage and Drainage System

 Building and Premises

• a) Walls and floors
• b) Adequate Working Space
• c) Logical Placement of Equipments and Material
• d) Air Handling Unit

• Method and Machine Validation

• a) Process Validation
• b) Performance Qualification
• c) Installation Qualification
• d) Design Qualification
• e) Operational Qualification

• Standard Operating Procedure and Standard Testing Procedure (SOP & STP)
• a) Purpose
• b) Scope in Industry
• c) Area of Operation
• d) Responsibility
• e) Procedure

 Manpower Training and Development

• a) To update with new technology
• b) To minimize the possibility of errors
• c) To minimize the risk of cross contamination
• d) Awareness of Personnel Hygiene
• e) Awareness of cleanliness and sanitation

2. Material Management :
• Vendor Selection and Development
• Purchase System
• Status of the received material
• Assuring Water System

3. Storage and Issue :

• Control over Approval and Release of Materials
• Dispensing of Material

4. Production :
• Manufacturing Process control and record
a) MFR : Master Formula Record
b) BMR : Batch Manufacturing Record
 c) BPR : Batch Process Record
• Release by QC/IPQC
• Environment Monitoring
• Quality Audit of all record before release
• Complete and Satisfactory QC check before release
• Monitoring of finished goods storage condition

5. Sales and Distribution :

• Commercial invoice for Distributors

6. QA Activity :
• Conducting Accelerated and Periodical Stability Studies
• Handling of Complaints, Rejection, Reprocessing and Recall
• Process and System Revival

9. QUALITY CONTROL
The concept of quality control refers to the process starving 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
product will retain all there claim till they are consumed. The sample should be inspected for defects
which could affect the performance or stability of the product.
 Fig 3.1 Quality control cycle

9.1. Quality Assurance & Quality Control in Pharma Industry

QA: It 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.
GMP: Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to
a quality appropriate to their intended use.
QC: Is that 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.

9.2. Quality Assurance (QA) Management Procedure:

 How to write Standard Operating Procedure: 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 your people can follow every day.

 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.

 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.

 Quality Documentation-Control, Tracking and Distribution:

• a. 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.
• b. It also describes the procedure of modification and review of existing document using a documentation
database.
• c. Management of existing and superseded documents is also a part of this procedure.
• d. You will see all the forms referred during the instruction are attached at the end of the procedure

9.3. Sampling of active pharmaceutical ingredients, Excipients, finished

product & packing material etc.
1. Testing of API (Active Pharmaceutical Ingredients).
2. Testing of excipients.
3. Testing of sample process.
4. Testing of finished products.
5. Testing of packing material.
6. Stability studies of finished product.
7. Maintenance and calibration of instruments.
8. Procurement of chemicals and glass ware.
9. Procurement of reference standard.
10. Procurement of maintenance of clusters for microbiological testing
11. To certificate analysis.
12. To study products complaints.
13. To destroy the control sample after six month of the date of expiry.

9.3.1. Quality control sampling section Responsibilities :

• To draw the sample of RM from store.
• To draw the samples of F.G. from production department.
• To keep control sample for reference & for stability studies.
• Final inspection of each batch.

9.3.2. Quality control chemical section Responsibilities :

• Complete analysis of all RM/ process & F.G. sample as per prescribed standard
• To send report to production, store. QC office.
• To carry out stability testing etc.


 Instrument maintenance and calibration
9.3.3. Quality control microbiology section Responsibilities :
• Microbiological analysis of RM/process/FG/sample.
• To send report to production, store, QC office.
• Quality control packaging material test.
• To carry out stability testing.

9.3.4. Quality control office Responsibilities :

• To make certificate of analysis of R.M. & finished products.
• To maintain & keep records of analysis & certificate of analysis.

9.3.5. Functions of quality control are :

• To prepare the detailed instructions for each test and analysis.
• To release or reject

a) Each batch of raw material

b) Semi finished /finished products
c) Packing & labeling material
To evaluate the conditions under goods are store.
To evaluate the quality & stability of product.
To establish and revise control procedure and specifications.

9.4. Procedure for Quality Control :

Step involved are:-
1. Raw Material Analysis: - After recording raw material in store division in store division quality control dept
is called for sampling for testing its quality and purity as per pharmacopoeias. Where the raw material stand in its
quality. The quality control passes the raw material for production.

2. In Process Control: - There is a real and significant difference between a finished product compounding
standard and the manufacturing process.

For quality assurance the sample size usually taken as:

• 40 Tablet (min.)
• 2 Liquid preparation (sealed)
• 2 Sterilized preparation (sealed)
• 40 Capsules
• 2 Powder preparations (packed)

Under in process control the sample is collected from immediately processed bulk. The process of sending
sample to quality control is very burdensome. So in order to case this process, convenient equipment is available
in the mfg. dept. near to the site or activity.
• Electronic balance – for testing weight variation.
• Hardness tester (Tablets)
• Measuring Cylinder – To measure volume of liquid preparation.
• Inspection chamber – To inspect antiforeigner particle or turbidity in solution.
• D.T. Machine
• Friabilator

The immediate recording of result is made in register is made in register with other information e.g. name of the
product, Batch No., Date, time etc.
Method used to check the quality
• Electronic method
• Solvent Extraction Method
 • Spectrophotometer Method
• Chromatographic Method

9.5. Program adopted for observing GMP and to build quality of the
product
There are many tests that are used for quality assurance of various formulations as :
• • For Tablets

From manufacturing batch of tablets 30-40 tablets are sent Q.C. to test them for :
• a) Weight Variation : A tablet must contain the proper amount of drugs. For testing weight variation a
sample of 10 tablets are taken hourly and weighted on electronic or physical balance. The tablets must have
acceptable average weight.

Fig 3.2 Electronic weight balance

b) Friability Testing : This is an internal standard test. This test is essentials for consumer
acceptance. Tablets require certain amount of strength to withstand mechanism shocks on handling packing, and
shipping.
 Fig 3.3 Friability tester

c) Hardness testing : Hardness testing determines the cursing strength of tablets. To check the hardness
the tablet is placed between two finger of tester both horizontally and vertically and force is applied. The
hardness of tablet must not be less than 4 kg, and not more than 6 kg.

d) Disintegration time : This is the time on which breakdown of tablet in GIT occurs. To test D.T. a
disintegration test apparatus is used that is set as per pharmacopeia. There are internal standards for D.T. i.e.
15minutes. If tablet disintegrates within 10 minutes then the batch of tablet is contained otherwise batch is
cancelled.

Fig 3.5 Disintegration Apparatus

e) Dissolution time : As the tablet break down in small particles it should offer a grater surface area to
the dissolved media. Dissolution apparatus is a 8 paddled machine and temperature, speed and time can be
adjusted.
 Fig 3.6 Dissolution apparatus

f) Strip leakage test : To test whether the strips are leak-proof or not.

• • For Capsules

a) Weight Variation : A sample of 10 tablets is hourly taken and average weight is taken. Then each capsule is
weighted individually and compared with average weight.
 Not content less than 300mg ---- 7.5
 Not content more than 300mg ---- 10%


b) Disintegration time : This is the time on which breakdown of tablet in GIT occurs. To test D.T. a
disintegration test apparatus is used that is set as per pharmacopeias. Starch paste is employed as disintegrating
agent who may draw water in to the tablet, causing tablet to swell and burst apart. There are internal standards
for D.T. i.e. 15minutes. If tablet disintegrates within 10 minutes then the batch of tablet is contained otherwise
batch is cancelled.

c) Dissolution time : As the tablet break down in small particles it should offer a grater surface area to
the dissolved media. Dissolution apparatus is a 8 paddled machine and temperature, speed and time can be
adjusted.

 Sterile Preparation
a) Clarity test : Clarity testing is carried out to check the particulate matter in the sample. In this test
transparent particles or white particles observed against the black background and the black or dark particles
observed against the white background.

b) Sterility test : Sterility can be defined as the freedom from the presence of viable microorganisms.

 It is done for detecting the presence of viable forms of bacteria, fungi and yeast in parenteral products.
 The test for Sterility must be carried out under strict aseptic conditions in order to avoid accidental
contamination of the product during test.
  All glassware's required for the test must be Sterile.
 Sterility testing attempts to reveal the presence or absence of viable microorganisms in a sample number
of containers taken from batch of product.
 Based on results obtained from testing the sample a decision is made as to the sterility of the batch.



• Record maintenance in q.c. :
For record maintenance in Q.C. there are separate recording registers, having columns for the name, batch No,
date & result for the product being analyzed e.g.:-
 One register for in process control analysis
 One register for in process control analysis
 One register for finished and packed product analysis

 Daily entry is made to avoid any error.

A part forms this, for incoming of reagent in Q.C. another record is maintained

• Microbiological analysis :
a) Fumigation:.
➢ This is a process to maintain asepsis in Lab.
➢ 500 ml of HCHO is mixed with 170 gm Potassium per magnate and is heated to vaporize.
➢ During fumigation either of both solutions is heated in room after closing it completely for over a
night.
➢ So that intimation of vapors may occur with every corner and instrument.
➢ Excess of HCHO is removed by soaking in Ammonia solution.
➢ After fumigation wipening of instruments and wall in carried out with 70% Isopropyl alcohol,
this maintains asepsis for a long time.
b) Auto-clave :
➢ Autoclave is the apparatus used to sterilize with pressurized steam,
➢ The autoclave is an essential unit of every microbiology laboratory,
➢ An autoclave is usually operated at a pressure of 15 lb in2, at which temperature of pure steam is
121 C.
➢ The length of time depends on the material which is sterilized.

Fig 3.7 Auto clave

c) Laminar flow bench
➢ It is device in which a septic handling, transferring, filling etc. processes are carried out.
➢ Consist of a HEPA Filter (Pole size 0.2μm) through which microbial free air is blown that pre the
contamination of the area from microbes.
➢ Before processing UV-light is set on area is allowed to sterilized than UV-light is set of window
are open (HEPA-filters remain on) and working is started.
➢ Whenever working is stop UV-light again set on to maintain the area sterile.
➢ It is used mostly for aseptic transfer of culture media to the Petri dishes and test tube and also
micro manipulation processes.

Fig 3.8 Laminar air flow

Hot air oven
➢ Hot air ovens are electrical devices used in sterilization.
➢ The oven uses dry heat to sterilize.
➢ They can be operated from 50 to 300 °C (122 to 572 °F).
➢ There is a thermostat controlling the temperature.
➢ The standard settings for a hot air oven are:
✓ 1.5 to 2 hours at 160 °C (320 °F)
✓ 6 to 12 minutes at 190 °C (374 °F)

Fig 3.9 Hot air oven

e) B.O.D. Incubator :
➢ Used to provide suitable climatic condition like Temperature, Oxygen etc. to the growing
microbes in culture mediums in fully controlled way.
➢ Used to incubate the culture for complete growth of microbes to develop.

Fig 3.10 Bod incubator

f) Membrane filter
➢ It is cellulose acetate / phthalate etc. derived circular pad of 100-150 μm thickness, 45 mm
diameter & 0.45 mm pore size.
➢ Fitted in a steel holder supported by a steel strainer and used to check the microbial
contamination in fluids.
➢ Ophthalmic water is passed through filter under Vacuum and the filter disc is divided in 4 parts
aseptically in Laminar Flow Bench. Two of which are transferred to fluid Thioglycolate media and
rests are transferred to casein digest media. (For aerobic and non-aerobic Bacteria) and are
incubated in B.O.D. for 7 days.
➢ Any kind of microbial growth shows microbial contamination of the fluid.

Fig 3.11 Membrane filter

g) Microbial colony counter
➢ Plate counting machine consist of a base plate printed with squares over which magnifying
lenses is present a touch counter electronic pen is used to count the colony that get displayed on
the screen.
 ➢ It is used for counting microbial colonies, Solid Agar Culture Media incubated for the validation
sterile area water containers of ophthalmic section filter membranes & autoclave

.
Fig 3.12 Microbial colony counter
h) Zone Of Inhibition Reader

➢ Consist of a Petridis holder that moves over a plate form below a reflector assembly.
➢ Whenever diameter of Z.O.I is to be measured the Petridis is placed in the holder and a prism is
kept on the Z.O.I. in disc.
➢ Assembly is moved below the reflector in such a way that adjustment makes the Z.O.I. visible
from the front.
➢ The reading on the meter shows the Z.O.I. in mm.
➢ Used to check the efficacy of antibiotics.

Fig 3.13 Digital antibiotic zone reader

10. RAW MATERIAL STORAGE AREA

The store department of raw material storage is divided in two compartments, one for excisable and other for non
excisable goods. The product is sent to the receiver along with one copy of bill which has information related to
Name, Amount, Tax and final cost of the product.
A raw material also known as a feedstock or most correctly unprocessed material, is a basic
material that is used to produce goods, finished products, energy or intermediate materials
which are feed stocks for future finished products. As feedstock, the term connotes these materials are
bottleneck assets and are highly important with regards to producing other products.
 The transporters consignment and a copy of bill are stored in commercial store. Entries of in
coming and outgoing goods are made in the same ledger. There are following auditors assigned for
inspections of records are:

1. Internal auditors - Check the ledger daily.

2. Excise auditors - Time to time check, especially for excisable goods.
3. Statutory auditors - Representatives of state govt., check through year.

10.1. The storage room is divided into following rooms:

1. Cold room : In which aluminum foil, empty capsules, loose drugs and vitamins are stored. Temperature of
this room is 15`c to 20`c.
2. Dispensing Room : Standard Operating Procedure for Dispensing of Raw Material (API-Active
Pharmaceutical Ingredient and Excipient) to the production department for the manufacturing of pharmaceutical
drug products.
3. Drug store Room
4. Excepient Room
5. Under test material store Room
6. Packaging material store Room

10.2. Steps involve in RM store

1. Receiving
2. Sampling
3. Storing
4. Dispensing

1. Receiving
• Raw material is supplied by vendors by placing order.
• After receiving the raw material check he ―Observation on pack‖.
• Segregate the raw material according to batch number.
• Pre entry cleaning of raw material by vacuum cleaner.
• Weighing of the raw material

2. Sampling
• Before sampling get line clearance by QA person.
• QC person test the sample of raw material under LAF by different tests and fill it in ―Observation on
sampling are and pack‖ and ―Certificate of analysis‖.
• Warehouse operators will paste the labels of ―Approved label‖ and ―Sampled label‖.
• Next sent raw material for storing.

3. Storing
• The raw material is stored at 3 different temperature zones –
• Ambient: Not more than 35 C
• Controlled temperature room: 15 – 25 C .
• Cold room: 2 – 8C
4. Dispensing

• Raw material is picked for dispensing according to ―Material pick list for process order‖ and dispensed
according to BMR prepared by QA personnel.
• Selection of raw material is done according to ―First expiry first dispense‖.
• Raw material is dispensed from dispensing booth under LAF to the production area.

11. PRODUCTION SECTION

Production (Manufacturing) Deal with all stages of pharmaceutical product manufacture – from
producing active ingredients, through to completion of finished products and even packaging. Due to this
diversity, work in this area can take many forms and involve the use of specialist machinery.
 Fig
5.1 Production Cycle

11.1 General Instructions and Precautions

• Ensure area and equipment cleanliness before starting the manufacturing operations.
• Production should be performed and supervised by competent people.
• All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling,
dispensing, processing, packaging and distribution should be done in accordance with written procedures or
instructions and, where necessary, recorded.
• All incoming materials should be checked to ensure that the consignment corresponds to the order.
• Containers should be cleaned where necessary and labelled with the prescribed data.
• Damage to containers and any other problem which might adversely affect the quality of a material
should be investigated, recorded and reported to the Quality Control Department.
• Incoming materials and finished products should be physically or administratively quarantined
immediately after receipt or processing, until they have been released for use or distribution.

• Intermediate and bulk products purchased as such should be handled on receipt as though they were starting
materials.
• All materials and products should be stored under the appropriate conditions established by the
manufacturer and in an orderly fashion to permit batch segregation and stock rotation.
• Checks on yields, and reconciliation of quantities, should be carried out as necessary to ensure that there
are no discrepancies outside acceptable limits.
• Operations on different products should not be carried out simultaneously or consecutively in the same
room unless there is no risk of mix-up or cross-contamination.
• At every stage of processing, products and materials should be protected from microbial and other
contamination.
• When working with dry materials and products, special precautions should be taken to prevent the
generation and dissemination of dust.
• This applies particularly to the handling of highly active or sensitising materials.
• At all times during processing, all materials, bulk containers, major items of equipment and where
appropriate rooms used should be labelled or otherwise identified with an indication of the product or material
being processed, its strength (where applicable) and batch number. Where applicable, this indication should also
mention the stage of production.
• Labels applied to containers, equipment or premises should be clear, unambiguous and in the company’s
agreed format.
• It is often helpful in addition to the wording on the labels to use colours to indicate status (for example,
quarantined, accepted, rejected, clean).
• Checks should be carried out to ensure that pipelines and other pieces of equipment used for the
transportation of products from one area to another are connected in a correct manner.
• Any deviation from instructions or procedures should be avoided as far as possible.
• If a deviation occurs, it should be approved in writing by a competent person, with the involvement of
the Quality Control department when appropriate.
• Access to production premises should be restricted to authorized personnel.
• Check and ensure that all manufacturing equipment and other required accessories are clean ready for
use.
• Wear gloves and nose mask during all manufacturing process.
• Counter check the weights of all ingredients before using in the batch.
• Get line clearance from QA for manufacturing.
• Air handling unit (AHU) system should be kept ON throughout the manufacturing process.
• Temperature should be kept between 25 C + 2 C and relative humidity should be kept between 50 +
10%.
• Ensure that QC approval purified water is being used for manufacturing purpose.
• Always transfer solution to the manufacturing vessels through 20 meshes.

11.2 TABLET PRODUCTION SECTION

Standard Screen No. (According to avg. wt.) in BMR :

1. 0.5 mm
2. 0.25 mm
3. 1 mm
4. 1.5 mm
5. 2 mm
6. 2.5 mm
7. 3 mm

11.2.1 Types of Tablet:

IP BP USP
Uncoated Uncoated Compressed/molded
Film Coated Coated Plain Coated
Enteric Coated Gastro Resistent (Enteric Delayed Release
 Coated)
Dispersible Tablet Dispersible Tablet Dispersible Tablet
Modified Release Tablet Modified Release Tablet Exteded Release Tablet
Soluble Tablet Soluble Tablet Soluble Tablet
Effervescent Tablet Effervescent Tablet Effervescent Tablet
For use in mouth (Chewable, For use in mouth (Chewable, Chewable/Buccal,
Lozenges, Sublingual) Lozenges, Sublingual) Sublingual
Orodispersible Orodispersible Orodispersible

11.2.2 Standards for Tablets:

IP BP USP
Content of Active Ingredient Content of Active Ingredient Content of Active Ingredient
Uniformity of weight Uniformity of weight Weight Variation
Uniformity of Content Uniformity of Content Uniformity of Content
DT DT DT
Dissolution Dissolution Dissolution

2) For Capsule :
Friability Test: This test is additional to check crushing strength of tablet by this test one can check Capping
&/or Lamination. USP limit is 0.5 to 1%. Rotation: - 25 rpm or 100 rotations in 4 min.
11.2.4 Uniformity of Content or Content Uniformity :
IP: Active less than 10mg or 10%,
BP: Active less than 2 mg or 2%,
USP: Active less than 25mg or 25%.
• • 10 tabs limit NMT 1 tab deviate 85 – 115% & none outside 75 – 125% of the Avg value/IP/BP/USP
(Relative Standard Deviation less than or equal to 6%),
• • If 2 or 3 individual values are outside the limits 85 – 115% of the Avg value, & none outside 75 –
125% repeat for 20 tabs.
• • Complies when 30 tabs NMT 3 of the individual values are outside the limit 85 – 115% of the Avg
value, and none outside 75 – 125%.

11.2.5 Disintegration Time: Uncoated NMT 15 min, in water with Disc 370C ± 20C
Tablet
Coated Tablet NMT 30 min, In water with Disc for Film
Coated Tab, and NMT 60 min Other than Film
coated tablet
Enteric Coated Tab Intact for 1 hr in 0.1 N HCl & disintegrate
within 2 hr in Mixed 6.8 Phosphate buffer.
According to USP 1 hr in Simulated gastric
fluid, then in Simulated Intestinal Fluid.
Dispersible/Soluble Within 3 min in water at 250C ± 10C (IP) & 15
– 250C (BP)
Orodispersible Within 1 min
Effervescent Tab 5 min in 250 ml water at 20 – 300C (IP) & 5
min in 200 ml water at 15-250C (BP)
Buccal & Sublingual Not Applicable but dissolve within 15 – 30min.
DT Apparatus:- Mesh Apperture:- 2mm (#10), Cycles:- 28 – 32 cycles/min, 50 – 60 mm distance from
bottom & top, Temp of water 370C ± 20C. If 1 or 2 tabs fail, repeat for 12 tabs.

11.3. Bioavailability: The rate and extent to which the active ingredient or active moiety is absorbed from
a drug product and becomes available at the site of action. For drug products that are not intended to be
absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the
rate and extent to which the active ingredient or active moiety becomes available at the site of action.

ANDA - Abbreviated New Drug Application.

IND – Investigational New Drug Application.

NDA – New Drug Application.

According to the BCS, drug substances are classified as follows:

Class I - High Solubility, High Permeability Class II - High Permeability, Low Solubility Class III -High
Solubility, Low Permeability Class IV - , Low Solubility Low Permeability
• • A drug substance is considered HIGHLY SOLUBLE when the highest dose strength is soluble in < 250
ml water over a pH range of 1 to 7.5.
• • A drug substance is considered HIGHLY PERMEABLE when the extent of absorption in humans is
determined to be > 90% of an administered dose, based on mass-balance or in comparison to an intravenous
reference dose.
• • A drug product is considered to be RAPIDLY DISSOLVING when > 85% of the labeled amount of
drug substance dissolves within 30 minutes using USP apparatus I or II in a volume of < 900 ml buffer solutions.

11.3.1 Dissolution Determination

• • USP apparatus I (basket) at 100 rpm or USP apparatus II (paddle) at 50 rpm.
• • Dissolution media (900 ml): 0.1 N HCl or simulated gastric fluid, pH 4.5 buffer, and pH 6.8 buffer or
simulated intestinal fluid.
• • Compare dissolution profiles of test and reference products using a similarity factor (f 2).

11.4. An array of tablet types

Immediate Release Uncoated Tablets: Usually no taste/stability issues. Coated Tablets: For
taste/stability/identification (coated with water-soluble/dispersible polymer–mixture of hydroxypropyl
cellulose/hydroxypropylmethyl cellulose); coating readily ruptures in GI tract. Enteric-Coated Tablets: For
drugs inactivated or destroyed in the stomach or for those causing irritation to the gastric mucosa; tablet passes
through the stomach but disintegrates in the intestines where absorption takes place. Excipients used for enteric
coating include cellulose acetate phthalate, mixtures of fats and fatty acids, etc. Multiple Compressed Tablets:
Multiple-layered tablets manufactured by using more than one compression cycle. Each layer contains a different
drug and each may be colored differently. Controlled Release Tablets: Improved therapy, less toxicity,
improved patient compliance—using polymers such as methacrylates. Sublingual Tablets: Small, flat ovals
such as nitroglycerin. They are ideal tablets for absorption of drugs which are destroyed by gastric juice or
undergo first pass metabolism.

Chewable Tablets: Disintegrate rapidly when chewed for patients with swallowing difficulty (children, elderly)
and when there is no access to water. Most commonly used for multiple vitamins and antacids Effervescent
Tablets: In addition to the active, this product form contains sodium bicarbonate and citric acid. When water is
added the ensuing chemical reaction forms carbon dioxide, which acts as a disintegrant and produces
effervescence that hastens dissolution (antacids).

11.5. INTRODUCTION TO INSTRUMENT

1. Paste kettle (Capacity : 100 litre) : Paste Kettle (starch paste kettle) including tilting paste kettle is
designed for paste preparation. Starch Paste Kettle confirms to cGMP norms and comprises of a jacketed
hemispherical bowl with all necessary steam accessories. Design principle of this kettle is the jacket for
passing steam in order to melt down the product to make paste.

Fig 5.2 Paste kettle

2. Rapid Mixer Granulator (Capacity : 250 kg/600 litre) : Rapid mixer granulator is used for
granulation in pharmaceutical manufacturing. Impellers and choppers are responsible for uniform
mixing and granule formation.
• Impellers: Impellers are fixed at the bottom of the dome-shaped stainless steel bowl. These
impellers are designed in such a way that small blades lift the material and full-length blades push
the material to mix well. These impellers break up the wet mass into small pieces and granules.
• Chopper: These are specially designed small blades located at the bottom of the dome. It
rotates at high speed (1440/2880) RPM to give easy and uniform granulation.
• Discharge Port: A discharge port is located horizontally at bottom of the dome. Granules
are unloaded in the container through the discharge port.
2. Fluidized bed dryer (Capacity : 250 kg) : Fluid or Fluidized bed dryer is a kind of equipment used
extensively in the pharmaceutical industries to reduce the moisture content in raw ingredients like
powder and granules. The working principle of this equipment includes fluidization of the fed materials.
In this process, hot air at a high temperature and pressure is introduced in the system through a perforated
bed of moist solid particulate.

Fig 5.4 Fluidized bed dryer

3. Vibro sifter: Vibro Sifter is a fundamental frill for the degree of materials in numerous research
facilities and modern cycles. It assists with isolating materials dependent on their molecule size.
Preferably, these are roundabout unitary gyratory screens that are likewise alluded to as vibrating sifters,
Vibro strainers, control sifters, or check screen.
 Fig 5.5 Vibro shifter

4. In process container (Capacity : 250 kg) : In Process Container which is used for handling of special
chemical, powders and granules materials. In Process Container is mainly used in the pharmaceutical
industries to avoid containment and cross contamination. This In Process Container is designed to create
a dust-free operation and ensure no human contamination occurs.

Fig 5.6 In process container

6. Hydraulic bin lifting : A hydraulic lift is a device for moving objects using force created by pressure on a
liquid inside a cylinder that moves a piston upward. Incompressible oil is pumped into the cylinder, which forces
the piston upward. When a valve opens to release the oil, the piston lowers by gravitational force.

7. Conta blender (Capacity : 750 litre) : Conta Blending system has replaced completely the conventional
blenders like 'V' shape / Double cone or Ribbon type. It is a latest cGMP concept with an emphasis on the dust
free transfer of powders and granules at different stages from sizing / dispensing to compression / filing of
Tablets or Capsules.
 Fig 5.7 Conta blender

8. Octa blender (Capacity : 1500 liter) : Octa Blender (octagonal mixer) including octagonal shape machine is
suitable for the mixing granular products. The machine offers great flexibility of operations as well as easy
cleaning and maintenance. Simple structure with cGMP-compliant design further enhances the functionality of
the machine. The Octagonal Blender is an efficient and versatile blending machine for mixing and lubrication
process of dry granules homogeneously.

Fig 5.8 Octa blender

9. Compression machine (27 Station) : Punch approx. 129600 tab/ hr.

A tablet compression machine is a mechanical device that compresses powder into tablets of uniform size by
pressing them together with great force to fuse the material together. Tablet compression machine can be used to
manufacture tablets of a wide variety of materials, including pharmaceuticals, cleaning products, and cosmetics.
Fig 5.9 Compression Machine
11.7 PRODUCTION (TABLET) :
11.7.1. BMR Report of Semethicone Tab.
• Batch No. T149301
• Temperature : 25℃
• Humidity : 60%
• Mfg. Date : 01/23
• Exp. Date : 12/24
• One tablet wt. : 1.306 g
• Diameter : 16.28 mm
• Thickness : 4.63 mm
• Hardness : 2.6 kg
• Friability Test: Fail (1.63 %)
• Batch size : 4 Lakh = 520kg (Total batch size 51 lakh)

PRODUCT DETAIL
Label Claim Composition ;
Each uncoated Tablet contains
Simethicone USP………………………125mg
Excipients…………………………..q.s
Product code T149
Mfg.Lic.No/Code No. MNB/05/269 & MB/05/270
Storage Condition Store Protect from light & moisture, at a temp.
not exceeding 30℃
Shelf life 24 months / 2 yrs
Market Export
Description(Uncoated) 16.0 mm, Orange Color, Round Shape, Flat,
Uncoated Chewable Tablet plain on both sides.
Average wt. (Uncoated) 1300.0 mg ± 3%
Uniformity of wt. ± 5% of Average wt.
Assay 90.0% to 110.0% of the label glimepiride IP –
2mg product claim

➢ Composition

• Dry mixing

a. Simethicone 50% powder

b. Microcrystalline cellulose plain

c. Maltodextrin

d. Sorbitol

e. Dextrose anhydrous

f. Sugar

• Paste Preparation

• a. Ethyl cellulose

• b. Isopropyl Alcohol

• • Lubrication

• a. Colloidal silicon dioxide

• b. Stearic acid

• c. Magnesium stearate

• d. Flavour (Strawberry)

• e. Colour (Sunset Yellow lake)

➢ List of Equipment used

• Paste kettle (Capacity : 100 litre)

• Rapid Mixer Granulator (Capacity : 250 kg/600 litre)

✓ Store for 15 min

✓ Impeller rotates with 80(Min.) to 160(Max.) RPM

✓ Chopper rotates with 1440(Slow) to 2880(High) RPM

• Fluidized bed dryer (Capacity: 250 kg)

✓ Store for 40(Min.) min to 60(Max.) min

• Vibro sifter

• In process container (Capacity: 250 kg)

• Hydraulic bin lifting

• Conta blender (Capacity: 750 liters)

✓ Rotates with 7-8 RPM

• Octa blender (Capacity: 1500 liter)

• Compression machine (27 Station) : Punch approx. 129600 tab/ hr.

• Compression machine (37 Station) : Punch approx. 222000 tab/ hr.

➢ Testing of Product Instruments

• Balance

• Vernier Caliper

• Friability Apparatus

• Hardness Tester

• Disintegration Apparatus

• IR Moisture Balance
 Fig 5.10 Simethicone tablet

11.7.2. BMR Report of Nystatin Tab.

• Date of Commencement: 27/01/2023

• Date of Completion: 30/01/2023

• Batch No. T147303

• Mfg. Date: 01/23

• Exp. Date: 12/25

• Batch Size: 3 Lakh

• One tablet wt.: 1.431 g

• Length: 24.55 mm

• Breadth: 10.05 mm

• Thickness: 5.78 mm

• Hardness: 8 kg

• Friability Test: Pass (0.56%)

• Disintegration Time: 4.35 min

• Temperature: 21℃

• Humidity: 53%

PRODUCT DETAIL
Label Claim Composition ;
Each uncoated Tablet contains
Nystatin USP………………………100000 IU
Excipients…………………………..q.s
Product code T147
Mfg.Lic.No/Code No. MNB/05/269 & MB/05/270
Storage Condition Store below 25 ℃, Protect from light &
moisture
Shelf life 36 months
Description(Uncoated) 24.40×10.0mm,Yellow Coloured, Bullet shape
uncoated tablet with both side plain
Average wt. (Uncoated) 1430.00 mg ± 3%
Uniformity of wt. ± 5% of Average wt.
Market Export
% Yield 99.96% (Manufacturing)
99.92% (Compression)

Yield Reconciliation

Step Description Qty Qty

(in kg) (in lakh)
A Theoretical batch size 429.00 300000
with respect to
dispensed material
B Actual Quantity of 428.710 299797
Lubricated Granules
C Sample Quantity 0.120 84
(L.O.D/ In Process
checks)
D Validation Sample - -
E Rejects (If any) 0.110 77
F Total accounted for 428.830 299881
(B+C+D)
G Unaccountable Loss 0.060 42
(A-F)
% Yield = F×100/A = 99.96%

Reconcilation of Compressed Tablets

Step Description Qty Qty
(in kg) (in lakh)
A Theoretical wt. of 428.00 299797
compressed tablets
B Actual Quantity of 428.238 299467
Compressed Tab.
C Sample Quantity (Q.C 0.143 100
/ In process checks)
D Validation Sample - -
E Rejects (If any) - -
F Total accounted for 428.381 299567
(B+C+D)
G Unaccountable Loss 0.329 230
(A-F)
% Yield = F×100/A = 99.92%

Type of Tooling: D Tooling

Specification Dies Upper Punch Lower Punch

Dimension 24.40×10.0mm 24.40×10.0mm 24.40×10.0mm
Shape Bullet Bullet Bullet
Marking ------------ Plain Plain

Standard Parameter

Appearance Yellow colored , uncoated, Initial & Every 30 min

Bullet shaped tablets with
both side plain
Marking / Embossing As per Punch Description Initial & Every 30 min
Wt. of 20 Tablets 28.600gm ±3% (27.742gm to Every 30 min
29.458gm)
Individual wt. of Tablet 1430mg ±3% (1387.1mg to Every 120 min
1472.9mg)
Disintegration Time NMT 15min Every 120 min
Uniformity of wt. ±5% of the avg. wt. found Every 120 min
(Pooled)
Hardness NLT – 8kg/cm2 Every 120 min
Thickness 6.3mm ±0.2mm Every 120 min
Friability NLT 1.0 % Every 120 min

Metal Detector Challenge

Test S.no Test Sample Standard
1. 0.15mm ferrous Should be rejected
2. 0.25mm Non ferrous Should be rejected
3. 0.25mm Stainless Steel Should be rejected
4. Dummy Sample Should be Pass

➢ Composition

• Dry mixing

a. Pregelatinized Starch 1500 USP

b. Lactose Monohydrate

c. Microcrystalline Cellulose

• Binders

a. Purified Water

• Lubrication

a. Nystation (4400IV/MG)

b. Colloidal silicon dioxide

c. Stearic acid

d. Purified Talcum

➢ List of Equipment used

• Paste kettle (Capacity : 100 litre)

• Rapid Mixer Granulator (Capacity : 250 kg/600 litre)

✓ Store for 15 min

✓ Impeller rotates with 80(Min.) to 160(Max.) RPM

✓ Chopper rotates with 1440(Slow) to 2880(High) RPM

• Fluidized bed dryer (Capacity : 250 kg)

✓ Store for 40(Min.) min to 60(Max.) min

 • Vibro sifter

• In process container (Capacity : 250 kg)

• Hydraulic bin lifting

• Conta blender (Capacity : 750 litre)

✓ Rotates with 7-8 RPM

• Octa blender (Capacity : 1500 litre)

• Compression machine (27 Station) : Punch approx. 129600 tab/ hr.

• Compression machine (37 Station) : Punch approx. 222000 tab/ hr.

• Colloidal Mill

• Auto Coater (Capacity : 170 litre each)

➢ Testing of Product Instruments

• Balance

• Vernier Caliper

• Friability Apparatus

• Hardness Tester

• Disintegration Apparatus

• IR Moisture Balance

Fig 5.11 Nystatin Tablets & strip

11.7.3. BMR Report of Memantine Tab. USP 10 mg

• Batch no. : T236301
• Batch size : 20.50 lakh
• Mfg. date : 01/2023
• Exp. Date : 12/2025
• Date of Commencement : 02/02/2023
• Date of Completion : 07/02/2023
•
PRODUCT DETAIL
Label Claim Composition ;
Each Film coated Tablet contains
Memantine HCL
USP………………………10mg
Excipients…………………………..q.s
Product code T236
Mfg.Lic.No/Code No. MNB/05/269 & MB/05/270
Storage Condition Store Protect from light & moisture, at a
temp. not exceeding 25℃
Shelf life 24 months / 2 yrs
Market Export
Description Red Color, Round Shape Tablet having one
side break line & plain on other side.
Average wt. (Uncoated) 100.0 mg ± 5%
Uniformity of wt. ±7.5% of Average wt.
Dissolution NLT 85%
Assay 90.0% to 110.0% of the label memantine USP
– 10mg product claim
% Yield 99.96% (Manufacturing)
99.82% (Compression)

➢ List of Equipment used

• Paste kettle (Capacity : 100 litre)

• Rapid Mixer Granulator (Capacity : 250 kg/600 litre)

✓ Store for 15 min

✓ Impeller rotates with 80(Min.) to 160(Max.) RPM

✓ Chopper rotates with 1440(Slow) to 2880(High) RPM

• Fluidized bed dryer (Capacity : 250 kg)

✓ Store for 40(Min.) min to 60(Max.) min

• Vibro sifter

• In process container (Capacity : 250 kg)

• Hydraulic bin lifting

• Conta blender (Capacity : 750 litre)

✓ Rotates with 7-8 RPM

 • Octa blender (Capacity : 1500 litre)

• Compression machine (27 Station) : Punch approx. 129600 tab/ hr.

• Compression machine (37 Station) : Punch approx. 222000 tab/ hr.

• Colloidal Mill

• Auto Coater (Capacity : 170 litre each)

➢ Testing of Product Instruments

• Balance

• Vernier Caliper

• Friability Apparatus

• Hardness Tester

• Disintegration Apparatus

• IR Moisture Balance

➢ List of Equipment used in Packaging

• Blister Packing Machine (Capacity 90000 tab/hrs)

• Blister Packing Machine BQS (Capacity 54000 tab/hrs)

➢ Testing of Product Instruments (After Packaging)

• Balance (Packing)

• Leak Test Apparatus

➢ Composition
• Dry mixing

a. Memantine HCL *

b. Lactose Monohydrate

c. MCC Plain

d. Maize Starch

• Binders

a. PVPK - 30

b. Isopropyl Alcohol
 • Lubrication

a. Maize Starch * (excess)

b. Sodium Starch Glycollate

c. Sodium Lauryl Sulphate

d. Colloidal Silicon Dioxide

e. Magnesium Stearate

f. Cross Carmellose Sodium

• Film Coating Material

a. Medicoat – White (Non aq.)

b. Color Iron oxide Red

c. IPA (isopropyl alcohol)

d. MDC (methylene dichloride)

e. Purified Talcum (for polishing)

Yield Reconcilation
Step Description Qty Qty
(in kg) (in lakh)
A Theoretical batch size 205.00 2050000
with respect to
dispensed material
B Actual Quantity of 204.90 2049000
Lubricated Granules
C Sample Quantity 0.020 200
(L.O.D/ In Process
checks)
D Validation Sample - -
E Rejects (If any) - -
F Total accounted for 204.920 2049200
(B+C+D)
G Unaccountable Loss 0.080 800
(A-F)
% Yield = F×100/A = 99.96%

Reconciliation of Compressed Tablets

Step Description Qty Qty

(in kg) (in lakh)
A Theoretical wt. of 204.90 2049000
compressed tablets
B Actual Quantity of 204.50 2045000
Compressed Tab.
C Sample Quantity (Q.C 0.05 500
 / In process checks)
D Validation Sample - -
E Rejects (If any) - -
F Total accounted for 204.55 2045500
(B+C+D)
G Unaccountable Loss 0.35 3500
(A-F)
% Yield = F×100/A = 99.82%

Reconciliation of Coated Tablets

Step Description Qty Qty

(in kg) (in lakh)
A Theoretical wt. of 204.50 2045000
compressed tablets
B Actual Quantity of 208.212 2041290
Compressed Tab.
C Sample Quantity (Q.C 0.002 20
/ In process checks)
D Validation Sample - -
E Rejects (If any) 0.184 1800
F Total accounted for 208.214 2041310
(B+C+D)
G Unaccountable Loss 0.193 1890
(A-F)
% Yield = F×100/A = 99.82%

Type of Tooling: B Tooling

Specification Dies Upper Punch Lower Punch
Dimension 6.00 mm 6.00 mm 6.00 mm
Shape Round Round, Concave Round, Concave
Marking ------------ Plain Plain
Parameter Specification Check Frequency
Appearance White, uncoated, round Initial & Every 30 min
tablets
Marking / Embossing As per Punch Description Initial & Every 30 min

Wt. of 20 Tablets 2.00gm ±3% (1.94gm to 2.06gm)

Individual wt. of Tablet 100mg ±5% (95mg to Every 120 min
105mg)
Disintegration Time NMT 15min Every 120 min
Uniformity of wt. ±7.5% of the avg. wt. found Every 120 min
(Pooled)
Hardness NLT – 4.0kg/cm2 Every 120 min
Thickness 3.0mm ±0.2mm Every 120 min
Friability NMT 1.0 % Every 120 min

Metal Detector Challenge Test

S.no Test Sample Standard

1. 0.15mm ferrous Should be rejected
2. 0.25mm Non ferrous Should be rejected
3. 0.25mm Stainless Steel Should be rejected
4. Dummy Sample Should be Pass

Fig 5.12 Memantine Tablets & Strip

 Fig 5.13 Memantine Tablet box

11.8. Production (Syrup)

11.8.1. BMR of Trimethoprim Suplamethoxazole Syrup
• Batch No. : L183001
• Batch size : 40000 bottle
• Quantity : 50ml
• Mfg. . Date : 02/2023
• Exp. Date : 01/2025
• Date of Commencement : 04/02/2023
• Date of Completion : 06/02/2023

Fig 5.14 Trimethoprim oral suspension label

PRODUCT DETAIL
Label Claim Composition ;
Each 5 ml contains
Trimethoprim IP……………………40mg
Sulphamethoxazole IP………………200mg
In a flavored syrupy base
Color : Panceau 4R
Product code L18
Mfg.Lic.No/Code No. MNB/05/269 & MB/05/270
Storage Condition Store Protect from light & moisture, don’t
allow to freeze
Shelf life 24 months / 2 yrs
Market Domestic (Rajasthan Govt. Supply)
Pack size Sale 60 ml (Till volume 50 ml)
Assay 90.0% to 110.0% of the label claim

List of equipment
1. Sugar Syrup Manufacturing Tank (Capacity : 3000 litre)
2. Manufacturing tank (Capacity : 4000 litre)
3. Storage tank (Capacity : 4000 litre)
4. Pre Filter Assembly
5. Bottle filling & sealing machine (capacity : 15000 bottle/hr.)
6. Bottle lifting machine
7. Bottle washing machine : (capacity: 15000bottle/hr.)
8. Carton coding machine : (capacity : 1000per hr.)

List of checking instrument

1. Balance (manufacturing)
2. Balance (dispensing rm)
3. Balance (dispensing packing)
4. Balance (packing)
5. Leak test apparatus

Calculation for trimethoprim IP.

Label claim × Batch size × 100 + overage %
5ml × assay ×1000

40 × 896.961 ×100 / 5 × 9 × 1000 = 7.248

8.891 × 5 × 99.25 × 1000 / 40 × 100 = 1103.039

= 2000 – 1103.039
= 896.961
8.891 + 7.248 = 16.139 + 5%
= 16.946 kg actual qty.
Calculation for Sulphamethoxale IP.

Label claim × Batch size × 100 + overage %

5ml × assay ×1000
= 200 mg×2000×100 / 5 ml×99.61×1000
= 84.329 kg

Composition / Raw Material

1. Sulphamethaoxale BP
2. Colloidal Silicon Dioxide IP/BP/USP
3. Citric acid Anhydrous BP
4. Methyl Paraben Sodium IP/BP/USP
5. Propyl Paraben Sodium IP/BP/USP
6. Bronapol IP/USP
7. Sorbitol 70% IP
8. Glycerin IP/BP
9. Disodium EDTA IP
10. Flavour Mixed Fruit
11. Sodium Saccharin IP
12. Color PONCEAU 4R Supra
13. Xanthan Gum IP Plain
14. Aspartame IP/BP/USP
15. Trimethoprim BP

Yield Reconciliation Record

S.no Details Kg/litre

1 Batch size 2000 L
2 Theoretical yield 1999.9 L
3 Sample Qty. for Analysis 0.100 L
4 Other Sample ----
5 % of yield limit (NLT 99.99 %
99.00 %)

In Process Control (During filling/ Sealing / Labeling)

S.no Parameter Observation

1 Temperature of Room Every 2 hrs.
2 Pressure Differential Every 2 hrs.
3 Wt. of fill Volume Every 1 hrs.
4 Sealing Every 1 hrs.
5 Leak Test Every 2 hrs.
6 Detail of Coding Every 2 hrs.
7 Supervision of Packing Every 2 hrs.
12. DECLARATION
I Ritik Dixit, do hereby solemnly declare that the work in this report was carried out by me as a
result of industrial training done at ANG Lifesciences Pvt. Ltd. The work I have presented does not
breach any existing copyright and no portion of this report is copied or any part thereof has been
submitted anywhere as an industrial training report or otherwise; hence I the author am solely
responsible for any mistakes or errors that may accrue. I also declare that any secondary information
that has been used has been duly acknowledged in this report.
I hereby declare that the industrial project work embodied in this entitled, carried out by me under
the supervision of Mr. Anuj Sood (HR Manager) ANG Lifesciences Pvt. Ltd.
I am indebted to my institutional guide, Ms. Shahnawaz Sir (Project guide) for their step by step
guidance throughout the preparation of Industrial training report.
I further declare this project work or any part of these has not been submitted by me anywhere for the
award of any degree or other similar title before & embodies result of my original work and the
contents of the case study do not from the basis for the award of my other degree.

Name : Ritik Dixit

Roll No : 2011370500046
 13. CONCLUSION
Industrial Training is a good opportunity for student to prepare to experiment the real working
environment in advanced. Student can experience a lot of skills and knowledge that difficult to get
from text book through the training. From the training, the skills that I get to experience have a lot as
I involve in the manufactured of gloves. In the first project, I manage to involve in the data collection
for human resource training process for operation. In the second project, I get to know how to
function the special instruments and study on the real industrial experiment. In the third project, I get
to learn the wiring of panel box, installation of electronic components and conduct the manufacturing
planning.

Beside these skills, I also learn how to communicate with other. As in this industry, there have a lot
of foreign worker that worked in the production line and even the office area.
So, it is a good chance for us to have more confident in communicate with them. With the different
language, I try my best to get what they trying to express and share with me. Beside the foreign
worker, sometimes we also ask to talk with the top management to get some confirmation. Even
there have our project owner followed, but it is important to behave what we said as we are just
trainee and we need to take care of the reputation of our department and university. Other than that, I
also always communicate with the colleague to make a good relationship with them. They also teach
me a lot of extra knowledge so that I can make use during my university tie or after join the society
later.

Through this 45 days industrial training, I get a lot knowledge from all the people that I thanks to. I
experience more than I wish to get. What I get already as a preparation for me to involve in new
environment. I found myself become more independent and mature. I able to handle the problem by
myself without asking other to solve it. I manage to solve the problem with the skill I had learnt and
discuss with the top management. All the way until the 45 days, communication skill is important
than other. If a student can’t manage to talk and communicate with other, industrial training is a good
opportunity to learn how to talk with other before enter society.