“INDUSTRIAL VISIT”

A Project Submitted
In Partial Fulfillment of the Requirement for the degree of
BACHELOR OF PHARMACY
BY
KRISHNA KUMAR VISHWAKARMA
Roll No. 1905540500057
Under the Supervision of
Prof. (DR.) SUCHANDRA GOSWAMI

NARAINA VIDYA PEETH GROUP OF INSTITUTION FACULTY OF

PHARMACY , KANPUR(COLLAGE CODE-554)

DR. A.P.J. ABDUL KALAM TECHNICAL UNIVERSITY

(Formerly Uttar Pradesh Technical University) LUCKNOW
 CERTIFICATE

Certified that KRISHNA KUMAR VISHWAKRMA has carried out industrial

visit for the award of Bachelor of Pharmacy from Dr. A.P.J Abdul Kalam
Technical University, Lucknow under Windlass Biotech. The industrial visit
report prepared by the student himself and the contents of the visit report do not
form the basis for the award of any degree to the candidate or to anybody else from
this or any other university.

Signature Dr. Diptendu Goswami

Director (Pharmacy)
Naraina Vidya Peeth Group of Institutions Faculty of Pharmacy
(Kanpur)

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 DECLARATION

I am KRISHNA KUMAR VISHWAKARMA hereby declare that the industrial training

report submitted to
Dr. A.P.J ABDUL KALAM TECHNICAL UNIVERSITY,
Lucknow for the award of Bachelor of Pharmacy, completed under the Windlas
Pvt. Ltd. The industrial visit report prepared by myself and the contents of the
industry visit report does not form the basis for the award of any degree from this
or any other university.

KRISHNA KUMAR
VISHWAKARMA
(1905540500057)

3
 ACKNOWLEDGEMENT
It is always a pleasure to remind the fine people in the Pharmacy program for their sincere
guidance. I received to uphold my practice as well as theoretical skill in pharmacy.

Firstly, I would to thank Dr. Diptendu Goswami (Director of Pharmacy) for

meticulously planning academic curriculum in such a way that students are not only
academically sound but ready for training pattern.

I would also like to acknowledge my immense pleasure and deep sense of gratitude
to Prof. (Dr.) SUCHNADRA GOSWAMI for the positive attitude he showed for
my work, always allowing me to question him and giving prompt replies for my
uncertainties in all field including educational, social and managerial work.

Finally, I would also like to thank faculty members of pharmacy for giving me
this opportunity and guiding me during the course of the training.

DATE: KRISHNA KUMAR VISHWAKARMA

1905540500057

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 CONTENTS
I. Certificate .................................................................................... (I)
II. Declaration................................................................................... (ii)
III. Endorsement by guide ................................................................ (iii)
IV. Endorsement by principal ........................................................... (iv)
V. Acknowledgement ...................................................................... (v)
VI. Table of contents ........................................................................(vi)

S. No. Title Page No.

1 Introduction 1-2
2 Manufacturing Section 3-9

3 Packaging Section 10-12

4 Testing Section 13-16
5 GMP Requirements 17-20
6 SOPs 21-25
7 Batch Manufacturing Record (BMR) 26-33
8 Analysis Record 34
9 Conclusion 35
10 Reference 36
 1) INTRODUCTION
Founded in the year 2001, Windlas provides
pharmaceutical development services, large-scale
manufacturing services and authentic yet
affordable products to its customers and
consumers around the world with a promise of
quality products and impeccable customer
service. We offer tie-up for third-party
manufacturing, franchisee marketing, loan
licensing, tender supply, export, and development
of new products through reverse engineering.

The Unit has already been audited and approved by MNC’s like Alkem LaboratoriesLtd. and IND
SWIFT, and Comed Chemicals Ltd., etc. It is equipped with ultra- modern machinery (as per GMP
norms laid down in Schedule M (revised) of the Drugs and Cosmetics Act), in-house well-
equipped laboratory ensuring stringent quality checks at each level of production, and an absolute
pollution free environment.

The unit also boasts its position as the only company in the region to have installedstate of the art
granulation machinery offering us a competitive advantage. Besides GMP certification, the
company is ISO 9001-2008 certified and is at par withWHO certification. The company is in the
process of receiving WHO certification.

Besides a state-of-the-art manufacturing facility, we offer management by industry professionals

with long technical experience from all across the country.

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 VISION AND MISSION

Service provider for end-to-end formulation development, licensing and commercial manufacturing of
generic/branded generics including complex formulations in compliance with current GMP & regulatory
requirements.

Service provider for Product Registration to Distribution in ROW/Semi regulated/selective regulated markets.

Strong Product Portfolio of First to launch in India products with DCGI clearance.

Approved for handling of Controlled substances/narcotics.

Associated partner for more than 100 leading Domestic Pharmaceuticals/MNCs

Strong presence for anti-diabetic, cardiovascular, neuropsychiatry, respiratory health and nutraceuticals;
gastroenterology, vitamins, minerals and supplements (“VMS”), analgesic, dermatological, cough/ cold etc.

24×7 B2B support for formulation development, inventory & supply chain management, commercial
manufacturing & distribution.

We are amongst the top five players in the domestic pharmaceutical formulations contract development and
manufacturing organization (“CDMO”) industry in India in terms of revenue. With over two decades of
experience in manufacturing both solid and liquid pharmaceutical dosage forms and significant experience in
providing specialized capabilities, including, high potency, controlled substances and low-solubility.

we provide a comprehensive range of CDMO services ranging from product discovery, product development,
licensing and commercial manufacturing of generic products, including complex generics, in compliance with
current Good Manufacturing Practices (“GMP”) with a focus on improved safety, efficacy and cost. In Fiscal
2020, our market share was approximately 1.5% in terms of revenue in the domestic formulations CDMO
industry. In addition to providing services and products in the CDMO market, we also sell our own branded
products in the trade generics and OTC markets as well as export generic products to several countries.

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The prevalence of chronic diseases in India has been increasing in the last few years, specifically in certain key
therapeutic categories, such as, anti-diabetic, cardiovascular, neuropsychiatry and respiratory therapies, that are
treated with ‘multi-drug therapy’ by physicians, i.e. the specific use of two or more drugs for single or multiple
chronic conditions in an individual. Moreover, multi-drug therapy has gained importance over the past few years
in the healthcare sector and is expected to aid the growth of pharmaceutical consumption. We have significant
experience in developing and manufacturing generic fixed dose combinations. Our focus has currently been on
launching new complex generic products in the chronic therapeutic category linked to lifestyle related disorders.

PRODUCTS MANUFACTURED

We provide third-party manufacturing facility for pharmaceutical industrialists and manufacturers. With strong
& well-developed Quality Control & Quality Assurance systems, we manufacture an extensive spectrum of
branded pharmaceutical formulations in any form. Our large-scale production capacities & highly skilled quality
control staff combine to give a perfect environment for outsourcing contract-manufacturing products. Our
services include products for:

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MANUFACTURING SECTION

Pharmaceutical manufacturing is the process of industrial scale synthesis of pharmaceutical drug

by pharmaceutical companies. The process can be broken downintoa series of unit operations such
as milling, drying, compression, and coating.

The primary goals of manufacturing section include: -

i. To formulate tablets that are strong and hard to withstand mechanical shockencountered
during manufacturing, packing, shipping, dispensing and use.
ii. To formulate tablets that are uniform in weight and in drug content.
iii. To formulate tablets that are bioavailable according to indication requirements.
iv. To formulate tablets that are chemically and physically stable over a long period of
time.
v. To formulate tablets that have elegant product identity which is free from any tablet
defects.
The manufacturing section have different sub division and these are as describedbelow:
a. Granulation Section
b. Blending Section
c. Compression Section
d. Coating Section

e. Granulation Section
Granulation is a process of collecting particles together by creating bonds between them and these
bonds are formed by compression or by using a binding agent. A process whereby small particles
gathered into large, permanent masses in which the original particles can still be identified.
Granulation process will improve flow and compression, characteristics, reduce segregation,
improve content uniformity, and eliminate excessive amounts of fine particles. The results will be
improved yields, reduced tablet defects, increased productivity, and reduced down time.
The equipment’s used in the process of Granulation are: -
i) Mass Mixer Tray Dryer
ii) FBD (Fluidized Bed Drier)
iii) Multi-mill
iv) Roll Compactor

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i) Mass Mixer
Mass Mixer is designed to perform smooth operations for thorough mixing equipped with safety
transparent dust cover & specially designed self-adjusting sealing arrangement, which ensures the
restriction of black particles enter the mixing drum. Mass Mixer is Ideal for dry & wet uniform
mixing of materials. Mass Mixer is available in sizes ranging from 5 Kg to 300 Kg as per GMP &
cGMP models.

Fig 5: - Mass Mixer

ii) Tray Dryer

A dryer used for drying of the wet products like crude drugs, chemicals, powders orthe granules,
etc. is known as Tray dryer.

The material which we want to dry is dispersed on the tiers of the trays. The tray, which is used in
this process must have perforated, solid or wire mesh bottoms. For the circulation of the air across
the drying materials, we lined the screen trays with paper. A limited amount of heat is provided to
every shelf at that time when the

10
wind passes over it to provide the latent heat of vaporization. This kind of dryers provides proper
control of humidity and temperature.

Fig 6: -Tray Dryer

iii) FBD (Fluidized Bed Dryer)

Fluidized (fluid) bed dryers are used extensively in the pharmaceutical industries to reduce
moisture content of pharmaceutical powder and granules. They have also found use in the drying
of suspension, slurries, solutions, dilute paste or sludges.

A typical fluidized bed dryer consists of the following components.

• Air preparatory unit.
• Product container.
• Exhaust filter.
• Exhaust blower.
• Control panel.
• Air distribution plate.
• Spray nozzle.
• Solution deliver.

In fluidized bed dryer, hot air is passed at high pressure through a perforated bottom of the
container containing the wet solids. The wet solids are lifted from the

bottom and suspended in a stream of air (fluidized state). The hot air then surroundsevery granule. Heat
transfer is accomplished by direct contact between the wet solidand hot gases. The vaporized liquid is
carried away.

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 Fig 7: - Fluidized Bed Dryer

iv) Multi-mill

Multi Mill is used in different functions involving wet & dry granulation, pulverization etc. of
Pharmaceutical, Chemical, Bulk drug, Cosmetic, Colors Food products etc. The Industrial Multi

Mill consists of stainless-steel hopper, processing chamber with beater assembly, Motor, DOL
stater, three speed pulley, and screen and study body.

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v) Roll Compactor
Roller Compactors are used to force fine powders between two counter rotating rolls and presses
the raw materials into a solid compact (flakes, sheets, strips). Roll Compacters are also called dry
granulators.

Principle: -
A roller compactor generally consists of three major units.
1) A feeding system, which converts the powder to the compaction area betweenthe rolls.
2) A compaction unit, where powder is compacted between two counter rotating rolls to a
ribbon by applying a force.
3) A size reduction unit, for milling the ribbons to the desired particle size.

The most important parameter in the dry granulation process is the force applied on the powder
compacted between two rolls. The applied force is expressed in kN/cm, being the force per cm roll
width.

Fig 9: - Roll Compactor

f. Blending Section

Blending is a process which mixes the API and excipients to ensure there is a homogeneous
mixture of the all ingredients for each manufacturing process. Blending is a process that can be
carried out numerous times within a manufacturingprocess when new excipients need to be added.

13
Blending is carried out by the help of Blender.

14
 Fig 10: - Blender
g. Compression Section

Tablet compression machine makes the tablets by pressing the granules in die with lower and upper
punch.

Different innovations to tablet compression machines are being done to improve the production
rates and now it is possible to produce more than 500,000 tabletsper hour. A tablet formation takes
place by the combined pressing action of two punches and a die.

Fig 11 - Single Rotary Compression Machine

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The basic principle behind the tablet compression machine is hydraulic pressure. This pressure is
transmitted unreduced through the static fluid. Any externally applied pressure is transmitted via
static fluid to all the directions in the same proportion. It also makes it possible to multiply the
force as needed.

The tablet compression procedure that is used in different pharmaceutical companiesis divided into
four distinct stages. These are: -

i) Filling

ii) Metering

iii) Compression

iv) Ejection

h. Coating Section
Coating is a process by which an essentially dry, outer layer of coating material is applied to the
surface of a dosage form in order to confer specific benefits over uncoated variety.

Coating may be applied to a wide range of oral solid dosage form, such as particles, powders,
granules, crystals, pellets and tablets. When coating composition is applied to a batch of tablets in
a coating pan, the tablet surfaces become covered with a tacky polymeric film.

Coating Machine

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 3) PACKAGING SECTION

Packaging is defined as the collection of different components which surround the pharmaceutical
product from the time of production until its use.

Importance of packaging

• Protect against all adverse external influences that can alter the properties of theproduct.
• Protect against biological contamination.
• Protect against physical damage.
• Carry the correct information and identification of the product.
• Tamper evident / Child resistance / Anti-counterfeiting.

There are mostly three types of packaging are used and these are as follows:
1- ALU- ALU P ackaging
2-Blister Packaging
3- Strip Packaging

a. ALU-ALU Packing
Ideal for products that need packaging between two sheets of aluminum foil, such as candies,
foodstuff, tablets and pills. The equipment is able to operate without light,and therefore meets the
requirement for sensitive products that are cannot tolerate exposure to light.

 Can also be used for plastic to plastic sealing

 Ideal for aluminum to aluminum foil heat sealed packaging of products
 The machine automatically completes functions such as cutting margin scrap,broken piece
filtering, and material feeding. Batch number printing can be automated, and even
transverse impressing.
 It is fully programmable via a programmable logic controller (PLC).
 Cutting speed and travel range are fully adjustable
 Gives accurate feeding, full purpose, ease of operation, tight sealing, stableperformance
 Can enhance the presentation of the product item and extend its durability

17
 Ideal for pharmaceutical companies.

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 Fig 13: - ALU-ALU Packing Machine
b. Blister Packing

This machine is ideal for packaging pharmaceutical materials in blister packs thatuse materials
such as polyvinyl chloride, polystyrene and polypropylene.

 The vibration feeder and crisp remover can remove the powder and crisps inside
medicine effectively.

 Horizontal perforation.
 Auto-counting slitting waster-side cutting.
 Automatically prints batch number.
 The diameter of the heat pressing cam can be modify from 110 to 140mm.

Fig 14: - Blister Packing Machine

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c. Strip Packing
A high-speed machine that is ideal for different products such as tablets or capsules.Machines are
robust and well-constructed and generally provide high quality by using accurate temperature
control, and the ability to exert variable pressure on the sealing rollers.
A strip packaging machine is ideal for coating heat sealable films such as polymer- coated
aluminum foil, and polymer-coated paper.
Important features of the machine are:
 Availability of Standard interchangeable parts
 Cutting arrangement are adjustable
 Quick and easy change of parts for application with different product types
 Precise knurling (sealing rollers)
 Smooth, silent operation
 Compact – minimal floor space

Fig 15: -Automatic Strip Packing Machine

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 4) TESTING SECTION
Tablets should be subjected to a number of tests before they are deemed fit for marketing and
consumption.
The tests that are performed during manufacturing process are as follow: -
a. Shape and Size of Tablets
b. Weight Variation Test
c. Friability Test
d. Hardness Test
e. Disintegration Test
f. Dissolution Test

a. Shape and Size of Tablets

It can be dimensionally described monitoring and checked visually the tablet shape is Round,
Elongated, Triangular, Oval, etc.
Tablet diameter and thickness can be measured by Vernier Calipers. Tablet
thickness should be controlled within a range of ± 5%.
b. Weight Variation Test
Weigh individually 20 units selected at random and calculate the average weight.
Not more than two of the individual weights deviates from the average weight by more than the
percentage given in the pharmacopeia and none deviates by more thantwice that percentage.

Table 1: - Weight Variation Limit according to IP, BP & USP

IP/BP Limit USP

80 mg or less ± 10% 130mg or less

More than 80mg or Less ± 7.5% 130mg to 324mg

than 250mg

250mg or more ± 5% More than

324mg

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c. Friability Test
Friability testing is a method, which is employed to determine physical strength of uncoated tablets
upon exposure to mechanical shock and attrition.

In this test 20 tablets are used; the rotation is 25 RPM per minutes and is done for 4minutes.

The tablets fall down from 6 inches height. The % weight loss should not be morethan 1%.
Percentage Friability = W1 – W2/W1 × 100 Where, W1
= weight of tablets before testing
W2 = weight of tablets after testing.

Fig 16: - Friability Test Apparatus

d. Hardness Test

Tablet hardness testing is a kind of laboratory technique, which is employed to test breaking point
of a tablet. For pharmaceutical units this process is an important part of medicine production that
ensures tablets must be hard enough to withstand mechanical stress during various conditions such
as storage and packaging, transportation and handling by the consumer etc.
There are two types of Hardness Tester: -
i) Monsanto Hardness Tester
ii) Pfizer Hardness Tester

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Fig 17: -Monsanto Hardness Tester Fig 18: - Pfizer Hardness Tester

e. Disintegration Test
Disintegration test is performed to find out that in how much time the tablet disintegrates. Sieves
size used in Disintegration test apparatus is 10 no. And up & down rotation is 28-32 cycles per
minutes at a height of 5-6 cm. The temperatureof liquid medium is 37°C.
Disintegration Time for tablets as per IP, BP and USP

Disintegration Time: -
i) Uncoated Tablet
NMT 15 min, in water with Disc 370C ± 20C

ii) Coated Tablet

NMT 30 min, in water with Disc for Film Coated Tab, and NMT 60 min Otherthan Film coated
tablet

iii) Enteric Coated Tab

Intact for 2 hr. in 0.1 N HCl & disintegrate within 1 hr. in Mixed 6.8 Phosphatebuffer.
According to USP 1 hr. in Simulated gastric fluid, then in Simulated IntestinalFluid.

iv) Dispersible/Soluble
Within 3 min in water at 250C ± 10C

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 Fig 19: - Disintegration Test Apparatus
f. Dissolution Test

A dissolution test is a means of identifying and proving the availability of active pharmaceutical
ingredient (API) in their delivered form. A dissolution test reflects the availability of active
substance and allows the prediction of the time for complete release of the material from the dosage
form.
There are many kinds of dosage forms of course and all of them have a dissolution rate. The
dissolution time can range from seconds to hours or even days for implantsaccording to IP, BP &
USP to the specified drugs.

Fig 20: - Tablet Dissolution Test Apparatus

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 5) GMP REQUIREMENTS
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently
produced and controlled according to quality standards.
It is designed to minimize the risks involved in any pharmaceutical production that cannot be
eliminated through testing the final product.
A product that conforms to GMP guidelines is considered to be of high quality andwill pose no
risk to consumers or the general public.

a. PRODUCTION
Principle
Production operations must follow clearly defined procedures; they must comply with the
principles of Good Manufacturing Practice in order to obtain products of the requisite quality and
be in accordance with the relevant manufacturing and marketing authorizations.
General
1) Production should be performed and supervised by competent people.
2) All handling of materials and products, such as receipt and quarantine, sampling, storage,
labeling, dispensing, processing, packaging and distribution should be done in accordance with
written procedures or instructions and should berecorded.
3) 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.
4) Damage to containers and any other problem which might adversely affect the quality
5) 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.

b. QUALITY CONTROL
Principle
Quality Control is concerned with sampling, specifications and testing as well as theorganization,
documentation and release procedures which ensure that the necessary and relevant tests are
carried out, and that materials are not released for

25
use, nor products released for sale or supply, until their quality has been judged satisfactory.
Quality Control is not confined to laboratory operations, but must be involved in all decisions
which may concern the quality of the product. The independence of Quality Control from
Production is considered fundamental to thesatisfactory operation of Quality Control.
General
1) Each holder of a manufacturing authorization should have a Quality Control Department. This
department should be independent from other departments, and under the authority of a person
with appropriate qualifications and experience, who has one or several control laboratories at
his disposal.
2) The Quality Control Department as a whole will also have other duties, such as to establish,
validate and implement all quality control procedures.
3) Finished product assessment should embrace all relevant factors, including production
conditions, results of in-process testing, a review of manufacturing (including packaging)
documentation, compliance with Finished Product Specification and examination of the final
finished pack.
4) Quality Control personnel should have access to production areas for sampling and
investigation as appropriate
5) Control Laboratory premises and equipment should meet the general and specificrequirements
for Quality Control areas.
6) The personnel, premises, and equipment in the laboratories should be appropriate to the tasks
imposed by the nature and the scale of the manufacturing operations. The use of outside
laboratories, in conformity with the principles detailed under Contract Analysis, can be
accepted for particular reasons, but this should be stated in the Quality Control records.

c. PACKAGING INSTRUCTIONS

There should be formally authorized Packaging Instructions for each product for pack size and
type. These should normally include, or have a reference to, the following:

1) Name of the product.

2) Description of its pharmaceutical form, and strength where applicable.

3) The pack size expressed in terms of the number, weight or volume of the productin the final
container.

26
4) A complete list of all the packaging materials required for a standard batch size, including
quantities, sizes and types, with the code or reference number relatingto the specifications of
each packaging material.

5) Where appropriate, an example or reproduction of the relevant printed packagingmaterials, and

specimens indicating where to apply batch number references, andshelf-life of the product.

6) Special precautions to be observed, including a careful examination of the area and equipment
in order to ascertain the line clearance before operations begin.

7) A description of the packaging operation, including any significant subsidiary operations, and
equipment to be used.

8) Details of in-process controls with instructions for sampling and acceptance limits.

d. STERILE PHARMACEUTICAL MANUFACTURING

Maintenance of sterile area is a critical task because of air, as well as the personnel working in the
sterile classified area, are the main source of the contamination. Following are some good
manufacturing practice points those shall help in the maintenance of sterile area.

1) Precautions to minimize contamination should be taken during all processing stages,

including the stages of sterilization.

2) Preparations containing live microorganisms should not be made or containers filled in areas
used for the processing of other pharmaceutical products; however, vaccines consisting of
dead organisms or of bacterial extracts may be dispensed into containers, after validated
inactivation and validated cleaning procedures, in the same premises as other sterile
pharmaceutical products.

3) The validation of aseptic processing should include simulating the process using a nutrient
medium. The form of the nutrient medium used should generally be equivalent to the dosage
form of the product. The process- simulation test should imitate as closely as possible the
routine aseptic manufacturing process and include all the critical subsequent manufacturing
steps.

4) Care should be taken to ensure that any validation does not compromise the processes.

27
5) Activities in clean areas, especially when aseptic operations are in progress, should be kept to
a minimum, and the movement of personnel should be controlled and methodical, so as to
avoid excessive shedding of particles and organisms due to over-vigorous activity. The
ambient temperature and humidityshould not be uncomfortably high because of the nature of
the garments worn.

6) The presence of containers and materials liable to generate fibers should be minimized in
clean areas and avoided completely when aseptic work is in progress.

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 6). SOPs (STANDARD OPERATING PROCEDURE)

A Standard Operating Procedure (SOP) is a set of written instructions that documenta routine or
repetitive activity which is followed by employees in an organization. The development and use
of SOPs are an integral part of a successful quality system. It provides information to perform a
job properly, and consistently in order to achieve pre-determined specification and quality end-
result.

a. SOPs for Compression Machine

• SETTING PROCEDURE FOR ROUND PUNCHES

1) Examine machine for cleanliness including rinse water results, dust-extraction unit and area.
Check punches and dies cleanliness.

2) Rotate hand wheel and check that turret rotates freely.

3) Check that pressure wheels are free and pressure is released.

4) Check that sockets of upper / lower punches and dies are properly cleaned.

5) Fit dies using die rod. Ensure that die is fitted in turret, tighten die holding screws.

6) Fit lower punches using thin coat of Food Grade Oil on punch barrel. Ensurethat punches are
‘freely moving’ by pushing the punch tips through die and allowing the punches to drop back
freely on its own weight. Tighten lower punches with plugs using anti turning strip.

7) Rotate hand wheel and check that all lower punches move freely.

8) Fit upper punches.

9) Close lower punch guard covers and fit the feed frame and check the clearance with turret.

10)Fix hopper in such way, so as to give 3-5 mm clearance from turret for free flow of
granules to the feed frame.

11)Rotate hand-wheel and check that machine is free.

12)Fit the acrylic guard. Check the condition of oil cups for any spillage of oil,which may
contaminate the product. Clean if necessary.

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13)Check tablet and granules containers, and polyethene bags, etc. for cleanliness.

14)Affix the Status label with Product Name, Batch Details to equipment, area and get the
clearance from Q.A.

15)Load granules in hopper, Rotate machine by hand to fill feed-frame and dies.

16)Apply pressure just to form tablet. Check weight of the tablet. Further increase the pressure to
produce required thickness of the tablet.

17)Put “ON” electric supply and press the green button of machine and check for required
Physical Appearance, Thickness, Hardness, Average Weight, Weight Variation, disintegration
time, friability and record in the BMR.

18)After setting all parameters, pharmacist should counter check the same.
• TABLET PARAMETER CHECKING

1) After the setting is complete. Put “ON” the mains. start the machine and check for following
parameters at specified frequency.

2) For Physical Appearance check the surface of all tablets obtained in one rotation for the
elegance and absence of defects such as sticking, picking and correctness of embossing.
Appearance to be checked after every two hours and after every break.

3) Weight Variation of 20 tablets after every 15 min.

4) Individual weight of tablets (weight variation) initially & after every 2 hours of one full rotation.

5) Thickness of tablets in one full rotation at the beginning of the batch and thenfor not less than
3 tablets afterwards every half an hour.

6) Hardness for not less than 3 tablets every half an hour.

7) Friability for tablets at start and afterwards every two hours.

8) Disintegration time for 6 tablets at start and afterwards every two hours.

9) After the compression is complete. Put “OFF” the mains.

10)Affix “To be Cleaned” label. & Fill the “Equipment Log Book”.

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b. SOPs for Blister Packing Machine

• PROCEDURE: MACHINE STARTING

1) Production person shall ensure the cleanliness of the Blister Pack Machine, its part & area and
‘CLEANED’ label on it.

2) Before starting the operation production person get the line clearance from Q.A person by
writing the status label with Product Name, Batch Det to equipment &area as per BMR.

3) Compressed air supply – “ON”.

4) Cooling unit – “ON”.

5) Mains – “ON” then control unit “ON”, PLC screen show. Press the main (F4), then select
Manual / Auto mode.

6) Vacuum “ON”, then Contact Heaters “ON” and Set temperature.

7) Sealing Heaters – “ON”.

8) Set knob to starting speed.

9) Lubricates Punch unit and web transport plate.

10) On attaining operating temperature.

• Engage Blister Sealing Roller.

• Start Machine for fresh blister web.

• Stop machine and insert Al Foil for sealing. 10.4 Insert sealed web in punching unit (Open
position) and check web tension behind ratchet.

• Start machine and adjust Idler roller of Batch code printing unit to get even over- printing.

• After satisfactory batch printing, engage tablet feeding unit and open gate for filling tablets
after 2 revolutions (approx.) of blister forming rolls record it in format.

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c. SOPs for Disintegration Test Apparatus

• Precautions:

1) Do not switch on the mains if water in the tank is not up to the mark.

2) While placing and removing the basket assembly do not apply excessive force.

3) Do not use abrasive materials to clean the instrument.

4) Do not bend the heater while cleaning the water bath.

• Operating instructions:

1) Ensure the cleanliness of area and the instrument.

2) Ensure that clean purified water is filled in the beakers till the desired level.

3) Switch ‘ON’ the Main supply & the instrument ‘On/Off’ switch on the rear side.

4) Switch ‘ON’ the heater by pressing ‘Temp’ key.

5) Press ‘Set’ &’Temp.’ key to set the temperature to 37°C.

6) Press ‘Set’ & ‘Timer’ key to set the desired test time.

7) Place one tablet / capsules to be tested in each of the six cylinders of basket rackassembly.

8) Place the disks if mentioned in the monograph.

9) Press ‘Start/Stop’ key once to start the test.

10)Watch the complete disintegration of the tablet / capsule and note down thetime.

11)Press ‘Start/Stop’ key to stop the test.

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d. SOPs for Friability Test Apparatus

• PROCEDURE: Operation

1) Weigh the specified number of tablets for the test.

2) Remove the acrylic cover of the drum and place the tablets inside the drum.
3) Replace the cover and tighten with the help of plastic knob taking care not totighten the
knob excessively as the drum and threading may get damaged.

4) Switch on the Main power supply; the display shall show "VEEGO
FRIABILITY TEST APPARATUS" for few seconds.

5) Then the display shall show “ENTER-START PROGRAM, INC-PROGRAM"

6) Then press the "START" key, display shall show both Set and Actual rotations.
7) When the actual rotations reach the Set rotations, the drum shall stop rotatingalong with a
beep sound.

8) Take out the tablets from the drum by removing the cover.
9) Weigh the tablets again and determine the loss in weight, calculate thepercentage.
• Procedure to Set Rotations:
1) Follow above procedure till step 5.
2) Then press "INC" switch.
3) Display shall show "SET ROTATIONS 0000", and the last digit shall beblinking.
4) Press "INC" switch till the last digit reaches desired figure.
5) Then press the "ENTER" key.
6) The third digit shall start blinking.
7) Continue as per steps 4 and 5 till value is set for each digit.
8) The display shall return to “ENTER-START TEST, INC-PROGRAM”.

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 7) BATCH MANUFACTURING RECORD (BMR)

Batch manufacturing record is a written document of the batch, prepared during pharmaceutical
manufacturing process. It contains actual data and step by step process for manufacturing each
batch.

This ensures that proper ingredients are added and each processing step is completedaccording to
the SOP and also ensures uniformity in finished product in each batch.

A good batch manufacturing record format should include following parts: -

a. Batch records

Batch records include master production and control records (MPCR) and batch production and
control records (BPCR). MPCR includes name of the product, name and codes of API, batch
formula, batch or code no., identification of equipment, line and location used, start and finishing
date with processing and packaging.

b. Bill of Material
Complete list of raw materials needed for manufacturing the finished product with required
quantity and weight.

c. General instruction for manufacturing

Clear instructions related to safety and health of operators, should be followed during the
manufacturing process.

d. Equipment cleaning record

Checklist for the cleaning of all equipment used in the manufacturing of the batch with the previous
product, batch and date of cleaning.

e. Yield
Yield of the batch should be calculated at the end of every stage to calculate the process loss. Final
yield should be calculated at the end of the manufacturing that should not be less than 99.00%.

f. Abbreviations
List of the abbreviations used in the batch manufacturing records (BMR) should be made to
understand easily.

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ANALYSIS RECORD

• ASSAY OF PARACETAMOL TABLETS

Paracetamol is a para-aminophenol derivative with analgesic and antipyretic properties. It is widely

used in several formulations and pharmaceutical presentationsthat are intended to optimize the use
of the medication by good absorption and reduction of secondary effects.

The test formulation allows a more rapid dissolution of the active principal ingredient
(paracetamol), which is intended to lead to a more rapid absorption.

• Procedure: -

1) Weigh and powder 20 tablets.

2) Take a quantity of the powder equivalent to 0.15 g of paracetamol 20 tablets * 0.5g

paracetamol wt. 0.15 g paracetamol X

3) Place in a volumetric flask (200ml)

4) Add 50 ml 0.1 M NaOH (using a burette)

5) Dilute with 100 ml of water, shake for 15 minutes, and add sufficient water toproduce 200
ml. Mix, and filter

6) Dilute 10 ml of the filtrate to 100 ml with water (in a volumetric flask 100ml).

7) Add 10ml of the resulting solution to 10 ml of 0.1 M NaOH, dilute to 100 mlwith water
(in a volumetric flask 100ml)

8) Measure the absorbance of the resulting solution at max = 257 nm taking 0.715as the value
of E1%

Blank:

Take 20 ml of 0.1 M NaOH and complete to 100 ml with waterLimit:

Content: 95-105% of the prescribed (labeled) amount.
35
 9) CONCLUSION

During Industrial training period, a lot of experience, knowledge and exposure that I have gained.
All disclosures were awakened in a boost of self- confidence toface life more challenging now.
Practical is a complement to the science or theory learned. This is clearly the concept of science
and charity, where they have learned without practice will be lost and will not give anything.

During my industrial training, there are many changes from the point of learning environments and
discussion among colleagues. It can directly increase the dedication and rational attitude toward
myself.

However, there are still some weaknesses that can be improved in the future. Therefore, I conclude
that the industrial training program has provided many benefitsto students even if there are minor
flaws that are somewhat disfiguring condition, so that this weakness can be rectified in the future.

I can conclude that this industry is through training I received a lot of exposure in the Pharmacy
world. I would like to thank all student for find their own experience with having Industrial
Training like this.

36
 10) REFERENCE

• Mehta R.M. ‘Pharmaceutics’ 2nd edition Vallabh Prakashan, Page no: -246-252

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

• Allen L. V and Ansel H. C. (2014). Ansel’s Pharmaceutical Dosage Forms and Drug Delivery
Systems. Philadelphia: Lippincott Williams and Wilkins.

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

• Debjit, B., Duraivel, S., Rajalakshmi, A. and Sampath K. (2014). Tablet

manufacturing process and defects of tablets. Elixir Pharmacy

• Jones D. (2008). Fasttrack Pharmaceutics – Dosage Form and Design. London:

Pharmaceutical Press.

• 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.

• Lachman, L., Lieberman, H. A., and Kanig, J. L. (1986), The Theory and Practiceof Industrial
Pharmacy, 3rd ed., Phila delphia: Lea & Febiger Page no: -1-74

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