A

REPORT ON INDUSTRIAL
TRAINING

SUBMITTED TOWARDS PARTIAL FULFILMENT

FOR THE DEGREE OF

BACHLORS OF PHARMACY
B.PHARM. VI SEMESTER
BY
NISHANT RAI
ROLL No.2002000500065

Maharana Pratap College of Pharmacy, Kanpur

To the
Faculty of Pharmacy

Dr. A.P.J. ABDUL KALAM TECHNICAL UNIVERSITY,

LUCKNOW
 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 like to thank to Dr. Vikram Sahu(Head 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 Mrs.

Priyanka Yadav for the positive attitude she showed for my work, always allowing me to

question her 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

Nishant Rai

MPCP
3 year

2
 CERTIFICATE

Certified that NISHANT RAI has carried out the project work presented in this report
entitled “ A REPORT ON INDUSTRIAL TRAINING” for the award of Bachelor of
Pharmacyfrom Dr APJ Abdul Kalam Technical University, Lucknow under my
supervision. The Project report embodies result of original work and studies carried out by
Student himself and the contents of the Project Report do not form the basis for the award
of any other degree to the candidate or to anybody else.

Head of Department
Dr Vikram Sahu

Internal examiner External Examiner

3
 DECLARATION

I, Nishant Rai hereby declare that the industrial visiting report submitted to Dr. A.P.J
ABDUL KALAM TECHNICAL UNIVERSITY, Lucknow for the award of Bachelor of
Pharmacy.
The industrial training report prepared by myself and the contents of the training report
does not form the basis for the award of other university any degree from this or any other
university

Nishant Rai
MPCP
3 year

4
 INDEX

 Tablet ....................................................................................................................... (6-22)

 Introduction to Tablet.
 Manufacturing process of Tablet.
 Coating of Tablet.
 Equipment
 Packaging and labelling of Tablet.
 Capsule ................................................................................................................. (23-29)
 Introduction to Capsule.
 Preparation of Gelatin.
 Capsule size chart.
 Equipments

 Quality Control .................................................................................................... (30-34)

 Study of GMP requirements ................................................................................ (35-37)
 Study of Batch Production Records..................................................................... (38-39)
 Study of Standard Operating Procedures ............................................................ (40-41)
 Reference ............................................................................................................ (42)

5
 Tablet

Introduction to tablet

Tablet is defined as a compressed solid dosage form containing medicaments with or

without excipients. According to the Indian Pharmacopoeia Pharmaceutical tablets are solid,
flat or biconvex dishes, unit dosage form, prepared by compressing a drugs or a mixture of
drugs, with or without diluents. They vary in shape and differ greatly in size and weight,
depending on amount of medicinal substances and the intended mode of administration. It is
the most popular dosage form and 70% of the total medicines are dispensed in the form of
Tablet. Tablet may be defined as a solid unit dosage form in which one usual dose of the
drug has been accurately place.

Route of administration

a. Orally
b. Sublingual
c. Rectal
d. Vaginal
Advantages

a. Easily swelled by water.

b. Patient acceptance is more when compared to injectable like I.V/ I.M
c. More attractive than the other dose form.
d. Safe and handy to use.
e. Easy to swallowing with least tendency for hang‐up
f. Sustained release product is possible by enteric coating.
g. Objectionable odour and bitter taste can be masked by coating technique.
h. Suitable for large scale production.

Disadvantages

a. Delayed in action than I.V, I.M or S.C

b. Not suitable for to unconscious Patient.
c. To avoid bitter taste encapsulation is done.

6
Ingredients

A. Diluents: lactose USP, mannitol USP, sorbitol, dextrose, microcrystalline cellulose.

b. Binder & adhesive: acacia, cellulose derivative &gluco-gelatin.
c. Disintegrants: starch derivative, cellulose derivative, alginate, PUP clay.
d. Lubricant: stearic acid and its salts.
e. Glidants: silica derivative, talc cornstarch.

7
 Granulation

Granulation is the process of forming grains or granules from a powdery or solid substance,
producing a granular material. It is applied in several technological processes in the chemical and
pharmaceutical industries. Typically, granulation involves agglomeration of fine particles into
larger granules, typically of size range between 0.2 and 4.0 mm depending on their subsequent
use. Less commonly, it involves shredding or grinding solid material into finer granules or
pellets. The manufacturing of granules for tablet compression may follow one or a combination
of three stabilized methods.

Types of Granulation

1. Dry granulation

The drug is sensitive to heat moisture or both aspirin &vitamin formulation is prepared. Hence
precaution has to be taken. the massing of a mix of dry primary powder particles using a
granulating fluid. The fluid contains a solvent that must be covered.This method is basically
applied to materials which cannot be prepared by wet granulation because of moisture
degradation properties or thermo-mobile properties of granules. It is carried out by two steps:

 Slugging:
After weighing and the mixing of ingredients, the powder mixture is slugged or compressed into
large flat tablets about one inch in diameter. Slugs are than broken up hand or mill and passed
through a screen of desired mess for sizing and sometimes lubricant are added and prepared by
compression.

 Roller compaction:
Instead of slugging, powder compactors may be used to increase the density of a powder by
pressing it between rollers at 1 ton to 6 tons of pressure. The compact material is broken up,
sized, and lubricated, and tablets are prepared by compression. Commonly used binding agents
are methyl cellulose or hydroxylmethyl cellulose (6-12%) which produces good hardness and
friability of tablet.

2. Wet Granulation

Wet granulation involves the massing of a mix of dry primary powder particles using a
granulating fluid (the process of adding a liquid solution to powders). The fluid contains a
solvent which must be volatile so that it can be removed by drying, and be non-toxic. Typical
liquids include water, ethanol and isopropanol, either alone or in combination. The granulation
liquid may be used alone or, more usually, as a solvent containing a dissolved adhesive (also
referred to as a binder or binding agent) which is used to ensure particle adhesion once the
granule is dry

8
3. Direct compression

In the direct compression method of tablet production, dry ingredients are thoroughly mixed and
then compressed into tablets.This involves the use of a special feeding device which prevents
segregation and enhances the flow of powders from the hopper into the die cavity of a tablet
press. The use of induced die feeder also reduces air entrapment, making the fill powder more
dense and amenable to compaction.Direct compression technique using induced die feeder is
used when formulation ingredients will compact but will not adequately fill the die cavity.

Fig No.1 Compression machine

Objectives

• To make the taste, odour, or color of the drug.

• To provide physical and chemical protection for drug.
• To control the release of the drug from the tablet.
• To protect the drug from the gastric environment of the stomach.
• To incorporate another drug or formula adjuvant in coating to avoid chemical
incompatibilities or to provide sequential drug release.
• To improve the pharmaceutical elegance by use of special color and contrasting
printing.

9
Types of Tablet Coating
 Film Coating
 Enteric Coating
 Sugar Coating
 Press Coating

1. Film Coating

This is more modern and widely used for tablet coating. Most of newly launched coated products
are film coated rather than sugar coating.

Film coating involves covering of tablet by thin film layer of coating liquid (polymer). Coating
liquid is sprayed in a rotating tablet bed or bed fluidized tablet which contains plasticizer,
polymer, colorant and solvent. The drying condition permits removal of solvent and leaves a thin
layer around each tablet. Sometimes aqueous solution or organic solutions are used to reduce
elimination of volatile organic compound, health and safety and cost reduction purposes. Film
coating polymer should have following properties-

[1] Optimum solubility to facilitate dissolution of final product. High soluble for immediate
release and low soluble for controlled release.

[2] Optimum viscosity to permit and trouble free spraying of solution.

[3] Optimum permeability to optimize shelf life of tablet preparation and some tuned to provide
an effective barrier oxygen and water vapor.

[4] Good mechanical strength to withstand the impact and abrasion encountered in normal
handling which avoids cracks and imperfections.

a. Film Formers

• Hydroxyl propyl methyl cellulose USP

• Methyl hydroxyethyl cellulose
• Ethyl cellulose
• Providence USP
• Acrylate polymer

10
2. Enteric Coating

Coating Material

 Cellulose acetate phthalate

 Acrylate polymer
 Polyvinyl acetate phthalate

3. Sugar coating

It is mainly done for masking the bitter taste of tablet. Before sugarcoating, the
core is coated with a sealing coat of shellac, PVP*-stabilized types of shellac, or other polymeric
materials, such as cellulose acetate phthalate and polyvinyl acetate phthalate.
The next stage is to build up a subcoat that will provide a good bridge between the main coating
and the sealed core, as well as round off any sharp corners. This step is followed by smoothing
or grossing. The finishing stage is accomplished by again applying one or two layers of clear
syrup. The tablets are then left for several hours before being transferred to the polishing pan.
The polish is a dilute wax solution (e.g., carnauba or beeswax in petroleum spirit) applied
sparingly until a high luster is produced.
Sugar coating involves the successive application of sucrose based solutions to tablet cores in
suitable equipment. Some stages in production of sugar coated tablets are-

[1] Sealing of tablet core- provide water proofing core from coating process and shellac,
cellulose acetate phthalate are normally used in sealing process.

[2] Sub coating- it is the actual start of sugar coating which provides necessary build-up to
roundup the tablet edge. Bulking agents such as calcium carbonate or talc added in sucrose
solution with gum.

[3] Smoothing – it increases tablet size to predetermined dimension by syrup solution. This
solution contains pigments, starch, gelatin, acacia or pacifier.

[4] Coloring- dyes or pigments

[5] Polishing- tablets need to be polished to achieve final elegance by waxes like beeswax,
carnubawax or hard paraffin.

[6] Printing

11
 4. Press coating

Press coating involves compaction of granules material around core of tablet with the use of
compressing equipment like ManestyDrycota. Today press coating is used in to separate
incompatible placed core and coating layer. This process requires some care and large or
irregularly sized agglomerate of granules may cause core to tilt in die.

Tablet Coating Pan

• Suitable for coating of tablets & confectionaries (sugar / film coat).

• Models from 36” to 72”.
• Suitable exhaust blower available heaters and blower motor is electrically
interlocked.
• Angle inclination of 450 and can be adjusted as per requirement.
• Drive unit with reduction gearbox provided.
• CGMP Model with documentation as option.
• Option – Buttle, AC drive, spraying system and polishing pan.

12
 EQUIPMENTS OF TABLET

1. Rapid Movement Granulation Machine

• This machine is widely used in Pharmaceutical, Food, Chemical & light industries
etc to blend powdery materials and granules.
• After pouring adhesives the powder material gradually changes into fine, damp
granules turn moist and their shapes begin paddle and inside wall of vessel, powdery
materials turn into loose.

Fig No 2. Rapid Movement Granulation Machine

13
Technical Specification

Model LGH 250 LGH 300

Capacity 70 110

Volume & Hopper 200 320

Power of Motor for Blending 15 18.5

Speed of Blending Paddle 170 140

Weight 1200 1600

Overall Dimension 215x1950x2100 2300x2200x2150

2. Fluidized Bed Dryer

• Dry of filter by 45 minutes 80 + 50C inlet temp. open RBB.

• Tool free dismantling of machine parts.
• In FBD 19 filter bags are found which made by Silicon or nylon.
• Automatic bag shaking, prematic bag & bowl sealing.
• Complete automatic with PLC.
• Model from 2 Kg to 250 Kg.

Fig No.3 Fluidized Bed Dryer

14
3. Sieving machine

• Separation of same size particles.

• Those particles are not sieve it again milling for size reduction.

Fig No.4Sieving Machine

4. Tablet compression Machine

Type of Compression Machine

a. Single Punch Machine

b. Multi Punch
c. Rotary Tablet Machine
d. High – Speed Rotary Tablet Machine
e. Multilayer Rotary Tablet Machine

Fig No.5Tablet Compression Machine

15
 Technical Specification

No. of Station 4

Type of toaling D

Max operating 5 tons

Output Tablets 256 to 480

Precaution During Compression

• Don’t give more presser upon the granules

• Proper lubrication of machine
• Adjust die size
• Proper cleaning

5. Coating Machine

a. Tablet Coating Pan

• Suitable for coating of tablets & confectionaries (sugar / film coat).

• Models from 36” to 72”.
• Suitable exhaust blower available heaters and blower motor is electrically
interlocked.
• Angle inclination of 450 and can be adjusted as per requirement.
• Drive unit with reduction gearbox provided.
• CGMP Model with documentation as option.

Option – Buttle, AC drive, spraying system and polishing pan.

16
 Technical Specification

Model PCP – 36 PCP – 42 PCP – 72

Pan size 36” 42” 72”

Loading capacity (Kgs) 80 100 275

Fig No.6 Tablet Coating Pan

17
b. Auto coater

• Specially designed bottle

• Enhanced clean in place
• Automated control system
• Suitable for film / Sugar coating
• Models available in 12” to 60”.

Fig No.7 Auto coater

18
6. Packaging Machine

• Blister Packing Machine

• Strip Packing Machine

a. Blister Packing Machine

Blister Packing Machine ALU – ALU

Blister Packing Machine ALU + PVC

Blister Packing Machine

“Model : PPC 2530 S (ALU + PVC)”

Features

• Pneumatic – Driven station controlled by full function High Speed PLC.

• Each station of machine is driven independently.
• Auto feeding
• GMP Model with sand Blasting

Machine Speed

• 30 Strokes / min. for Thermo Formed Blister

• 25 Strokes / min. for Cold Formed Blister.

Base Film

• Thermo formable PVC, PVC with PE/PVDC

• Cold Forming Tri-Laminated Aluminium

19
Fig No.8Automatic Blister packing machine

20
 Packaging & Labelling of tablets

Packaging and Labeling of tablets are done in Packaging and Labeling area. In this area
concurrently three actions i.e. visual checking for contaminant or deformity, Labeling
and Packing are taking place. This room is fitted with air-conditioners and a temperature
of about 27◦C is maintained. This area has a inspection table where deformity and
contamination are checked against black and white background.

Types of Packaging

1. Blister Packing

This is useful for packaging of unit dose of pharmaceuticals. This packing mode has
been used extensively for several good reasons. It is a packaging configuration capable
of providing excellent environmental protection, coupled with an aesthetically pleasing
and efficacious appearance. The blister package is formed by heat softening a sheet of
thermoplastic resin and vacuum drawing the softened sheets of plastic into a contoured
mould.

After coming, the sheet is released from the mould and proceeds to the filling station of
the packaging machine. The semi-rigid blister previously formed, is filled with the
product and lidded with a heat sealable backing material. The backing material can be
either a push through or peelable type.
For a push through type of blister, the backing material is usually heat seal coated
aluminum foil.

Fig No. 9Blister Packing

21
2. Strip Packing

The strip packing is done by aluminum foil or glassine poly paper. A strip package is
formed by feeding two webs of a heat sealable flexible film through either a heated
crimping roller or a heated reciprocating platen.

The product is dropped into the pocket formed prior to forming the final set of
seals. A continuous set of packets is formed, generally several packets wide depending
on the packaging machine’s limitations. The strip of packets is cut to the desired number
of packets in length.

The strips formed are usually collected and packed into a folding carton. The product
sealed between the two sheets of film usually has a seal around each tablet, with
perforations usually separating adjacent packets. The packaging of the final product is
done in paper cartons, manually, and is finally sealed

Fig No. 10 Strip Packing

22
 CAPSULE

Introduction of Capsule

Capsule may be defined as solid unit dosage forms of medicament in which the drug is
enclosed in a practically tasteless, hard or soft soluble container or shell made up of a
suitable form of gelatin.

Selecting a capsule type

The most widely used capsules can be classified below. Dry-filled capsules include mainly hard
gelatin and hard hydroxypropyl methylcellulose or hypromellose (HPMC) capsules. Liquid-filled
capsules include hard capsules (gelatin or HPMC) and soft gel gelatin capsules.

The larges size (000) is mainly used in veterinary practice. Fill weights increase with the size of
the capsule as well as with the bulk density of the filled material, which can range from 0.3–1.5
g/cc. Fill weights in the smallest capsules might be 39 mg, for example; the largest may weigh
1425 mg.

The shell of hard gelatin capsules contains 13–16% water. Storage of hard-gelatin capsules at
very low humidity can cause them to turn brittle. Gelatin capsules do not protect hygroscopic
materials from atmospheric water vapor because moisture can diffuse through the gelatin wall. If
stored at high humidity, the capsules become flaccid. In such cases, primary packaging material
such as aluminum strip packing, moisture barrier blister foil (e.g., Aclar), or bottle packs should
be used.

23
Hard gelatin capsules. The gelatin used in the manufacture of most common capsules is
obtained from collagenous material by hydrolysis. Gelatin is a natural, safe, non-allergenic,
clean, and economical ingredient. The two-piece hard gelatin capsule is available in a range of
sizes; from largest to smallest, these sizes are 000, 0, 1, 2, 3, 4, 5.

Soft gelatin capsules (SGC). SGC have soft, globular, gelatin shells somewhat thicker than that
of hard gelatin capsules. The gelation is plasticized by the addition of glycerin, sorbitol, or a
similar polyol. It may contain preservative to prevent the fungal growth. Large-scale production
methods are generally required for the preparation of SGC.

Advantage

• Capsule are tasteless, Odorless and can be easily administered

• Patient acceptance is more When Compared to Injectable like I.V/ I.M
• More attractive than other dosage form (Handy, easy to carry)
• Safe to use and self-medication may done / unit dose

Disadvantage

• The drugs which are hygroscopic are not suitable for filling into capsule.
• Delayed in action than i.v.i.m. or s.c.
• Not suitable for to unconscious Patient
• An accurate amount of medicament even if very small can be incorporated.

Processing of Capsule

CAPSULE LOADING CAPSULE FILLING POLISHING

PACKING

24
Preparation of gelatin

25
Capsule size chart

26
 EQUIPMENTS OF CAPSULE

1. Semi-Automatic Capsule Filling Machine

The Semi-Automatic Capsule filling machine is a user-friendly machine available with

advanced features. These features provide a high degree of automation which, coupled
with sound manufacturing practice, result in higher levels of
• Fill weight accuracy
• Formulation yields
• Maintenance free operation
• Operator ease and safety

Technical Specification

Capsule Size 00 0 1 to 5
No. Of Holes / Loading Ring 360 420 480
Output Per Hour 21,600 25,200 48,960
With ring loading system 42,840 48,960
36,700
Output
Per
Hour
415 V,
3
Output Phase,
Electric 50 Hz
Supply
1.125
Drive kW
Motor (1.5HP)
380mm to 500mm of Hg at 1000 lts/min (15" to 20" of
Vacuum Hg at 35 cfm)
required 5-7 Kg/Sq. cm at 142 lts/min (70-100 psiat
Compressed
Air
5cfm) 525 Kgs.
Weight
Dimensions
Shipping 1650mm x 1130mm x 1530mm (L x W x H)
Dimensions 1400mm x 950mm x 1680mm (L x W x H)

27
2.Automatic Capsule Filling Machine

High Speed Automatic Capsule Filling machines are suitable for filling powders and pellets.
These are versatile machines with several outstanding features both functional and
mechanical. Capsule fillers are used to fill hard gelatin and non-gelatin capsules with pre-
determined quantity of liquids, powders, pellets, tablets. Most machines conform to the GMP
guidelines with various safety features for maximum operator protection. Capsules are
normally fed into the machine, the filler then align, opens and accurately fills each capsule
and recloses.

Output

Model - A 40,000 capsules per hour for powder & 30,000 capsules per
40 hour for pellets.

Model - A 90,000 capsules per hour for powder & 70,000 capsules per
90 hour for pellets.

Fig No. 11 Automatic Capsule Filling Machine

28
3.Capsule Polishing and Sorting Machine

Model HSL-100A capsule polishing and sorting machine is an advanced machine with new
compare it with the traditional ones it has apparent advantage for its function and structure.
The main characters are:

• Small size, good looking, adjustable height and angles. It can be connected to
any types of capsule filling machines. Timely polishing while producing is
realized to raise the polishing quality and efficiency.

• It can automatically sort out capsules with low weight, empty body, scrap and
loose piece to meet GMP standard.

• High quality stainless steel is used inside the medicine-polishing chamber. Quick
connecting parts are also adopted to dismount the equipment more easily and to
clean more thoroughly.
• Quick detachable brush and bearing are used for the main axle. The brush and
bearing can be dismounted easily. The hair of brush will not drop.Different sizes
of brushes can be changed to meet the needs of different medicines.

• A safety device is equipped. The speed of motor is controlled by converter.

The polisher can continue to work for long time and stands moment of force.

Fig No.12Capsule Polishing and Sorting Machine

29
 QUALITY CONTROL

Quality control may be define as the check the quality of Raw material, finished product or
packing material.

Purpose:

• To insure the quality of product

• To know the self-life of product
• To know the potency of sample

Sampling:
Sampling mean to take the small quantity of Raw material or finished material for check
the quality.

Sampling

Raw Material Packing Material Finished Product

Visible Inspection To check the type of For insure the self life or
(Such as Batch No., packing and printing potency of product
Lic. No. or Mfg. upon carton
Date, Ex. date

30
 Equipment for Quality Control of Tablet

1. Dissolution Tester

TDT – O8L, CE
• Complies with USP, IP, EP specifications.
• Ideal for standard and sustain release drug.
• Station with easy snap-fit shafts for paddles and basket.
• Vibration free system.
• Low evaporation vessel lid.
• Magnetically coupled water circulating pump for precise temperature control of
water bath.

Fig No.13 Dissolution Tester

31
2. Disintegration Apparatus

This apparatus principle to provide a disintegration media and specific motion and tablet
are disintegrating a specific time.

The disintegration media - 0.1 N Hcl

Apparatus move - 28 to 30 rpm

Disintegration time

Enteric Coated Tablet - above 45 min.

Film Coated - 30 min.
Uncoated - 15 to 30 min.

• In Disintegration apparatus testing tube 6 tablet.

• Yet 5 tablet pass disintegration but one tablet are failed take 12 repeating
procedure.

Fig No.14Disintegration Apparatus

32
3. Tablet hardness Tester

• Tablet hardness measurement by load cell.

• Hardness measuring range upto 500 Newton.
• Accuracy of + 0.5% of full scale.Tablet scale – 2 mm to 8 mm.

Fig No.15Tablet hardness tester

4. Friability Apparatus

It checks the friabilation in tablet. If it is more than 0.5% friability found in tablet that
mean tablet quality is poor.

Clean an Switch on 2 Tablet filled in

(2 tablet weight )

At 25 rpm it moves
aroun

Again weight To calculate

2 friabilit

33
Weight of 20 tablet Weight of 20 tablet
–
Friability = before friability after friability X 100

Weight of 20 tablet before friability

Fig No.16 Friability Apparatus

5. Leak Detector

• Ideal for checking leakage of packed strip, blister and small sachets.
• Meets USP and package practice specification.
• Programmable vaccum level & hold time.

Fig No.17Leak Detector

34
Good Manufacturing Practices (GMP)

GMP are the part of quality assurance that ensures that drugs are consistently produced
and controlled in such a way to meet the quality standards appropriate to their intended
use, as required by the marketing authorization.

GMP basic requirements are as follows:

1. Manufacturing processes are clearly defined and controlled to ensure consistency and
compliance with approved specifications;

2. Critical steps of manufacturing processes and significant changes to the process are
validated;

3. All necessary key elements for GMP are provided, including the following: -

a. qualified and trained personnel,

b. adequate premises and space,

c. suitable equipment and services,

d. correct materials, containers and labels,

e. approved procedures and instructions,

f. suitable storage and transport.

4. Instructions and procedures are written in clear and unambiguous language; Health
Canada / Health Products and Food Branch Inspectorate Good

Manufacturing Practices (GMP) Guidelines – 2009 Edition, Version 2 (GUI-0001) /

March 4, 2011 Page 8 of 100

5. Operators are trained to carry out and document procedures;

6. Records are made during manufacture that demonstrate that all the steps required by
the defined procedures and instructions were in fact taken and that the quantity and
quality of the drug was as expected. Deviations are investigated and documented;

35
7. Records of fabrication, packaging, labelling, testing, distribution, importation, and
wholesaling that enable the complete history of a lot to be traced are retained in a
comprehensible and accessible form;

8. Control of storage, handling, and transportation of the drugs minimizes any risk to
their quality;

9. A system is available for recalling of drugs from sale;

10. Complaints about drugs are examined, the causes of quality defects are investigated,
and appropriate measures are taken with respect to the defective drugs and to prevent
recurrence.

Purpose

To provide interpretive guidance for Part C, Division 2, of the Food and Drug Regulations.
These guidelines are designed to facilitate compliance by the regulated industry and to
enhance consistency in the application of the regulatory requirements.

36
37
 Batch Production Record (BPR)

Batch production records should be prepared for each intermediate and

API/formulation and should include complete information relating to the
manufacturing and control of each batch.
The batch production record should be checked before issuance to assure that it is the
correct version and a legible accurate reproduction of the appropriate master production
instruction.
Before any processing begins, a check should be performed and recorded to ensure that
the equipment and workstation are clear of previous products, documents, or materials
not required for the planned process and that the equipment is clean and suitable for use.
These records should be numbered with a unique batch or identification number and
dated and signed when issued.

Documentation of completion of each significant step in the BPR should include

• Dates and, when appropriate, times

• Identity of major equipment used (e.g., reactors, driers, mills, etc.)
• Actual results recorded for critical process parameters
• Any sampling performed
• Specific identification of each batch, including weights, measures, and batch
numbers of raw materials, intermediates, or any reprocessed materials used
during manufacturing
• Signatures of the persons performing and directly supervising or checking each
critical step in the operation
• In-process and laboratory test results
• Actual yield at appropriate phases or times
• Description of packaging and label
• Representative label (commercial supply)
• Any deviation noted, its evaluation, and investigation
conducted (if appropriate) or reference to that investigation (if
stored separately).
• A decision for the release or rejection of the batch, with the date and
signature of the person responsible for the decision.
• Results of release testing
• Production and quality control records should be reviewed as part of the
approval process of batch release.

38
 Batch Production Record Attachments

Responsibility
a. Primary: Production Chemist.
b. Secondary: Production Officer.

Following attachments required to be attached to BPR before submitting the

completed BPR to Quality Assurance.

Equipment clean record status label.

 Equipment clean record.

 Raw materials dispensed weighing slip.

 Intermediate raw material sealed.
 Transfer note for finished goods to F.G. store.

 Raw material issue order (P.R).

 IPQC- In Process Test Request cum Report.

 Excess material requisition (S.R.).

 Deviation note if any.

 Certificate of Analysis (COA).

 Finish product dispatch data.

39
 Standard Operating Procedure (SOP)

Introduction of SOP

An SOP is a procedure specific to your operation that describes the activities necessary to
complete tasks in accordance with industry regulations, provincial laws or even just your
own standards for running your business. Any document that is a “how to” falls into the
category of procedures. In a manufacturing environment, the most obvious example of an
SOP is the step by step production line procedures used to make products as well train staff.
An SOP, in fact, defines expected practices in all businesses where quality standards
exist. SOPs play an important role in your small business. SOPs are policies, procedures
and standards you need in the operations, marketing and administration disciplines
within your business to ensure success. These can create:
• efficiencies, and therefore profitability
• consistency and reliability in production and service
• fewer errors in all areas
• a way to resolve conflicts between partners
• a healthy and safe environment
• protection of employers in areas of potential liability and personnel matters
• a roadmap for how to resolve issues – and the removal of emotion from
troubleshooting – allowing needed focus on solving the problem
• a first line of defense in any inspection, whether it be by a regulatory body, a partner
or potential partner, a client, or a firm conducting due diligence for a possible
purchase
• value added to your business should you ever wish to sell it.
Developing an SOP is about systemizing all of your processes and documenting them.
Every business has a unique market, every entrepreneur has his/her own leadership style,
and every industry has its own best practices. No two businesses will have an identical
collection of SOPs. Below is a listing of just a few typical SOPs, which you will want to
consider writing for your own small business.

Production/Operation

a. production line steps.

b. equipment maintenance, inspection procedures.
c. new employee training.

40
Finance and Administration

• accounts receivable – billing and collections process

• accounts payable process – maximizing cash flow while meeting all payment
deadlines.

Marketing, Sales and Customer Service

• approval of external communications: press releases, social media, advert, etc.

• preparation of sales quotes
• service delivery process, including response times
• warranty, guarantee, refund/exchange policies
• acknowledgment/resolution of complaints, customer comments and suggestions.

Employing Staff

• job descriptions
• employee orientation and training
• corrective action and discipline
• performance reviews
• use of Internet and social media for business purposes.

Tips

• establish prior to opening; review at least annually

• develop procedures in the language, style and format best for the establishment
(your industry/operations knowledge is crucial here)
• write SOPs in clear, concise language so that processes and activities occur as they are
supposed to
• the level of detail in SOPs should provide adequate information to keep performance
consistent while keeping the procedures from becoming impractical
• keep written SOPs on-site so that they can be used by supervisors and employees
• drafts should be made and tested before an SOP is released for implementation
• the more decision makers, employees and complexity in the business, the more SOPs
are required.

41
 REFERENCE

 Lachman, L. et al “THE Theory and Practice of Industrial PHARMACY”, Varghese

Publishing House, Third Edition, 1990, Page no. 293-390. 
 Remington’s Pharmaceutical Sciences, Vol.I&Vol.II, Mack Publishing Co., U.S.A. 
 H.C. Ansel, Introduction to Pharmaceutical Dosage Forms, Lea & Fibiger,
Philadelphia, U.S.A.
 Gupta, A.K., Bajaj S.S., “Introduction to Pharmaceutics - II”, CBS Publisher &
Distributor, Fourth Edition, 2000, Page no. 184.
 https://www.brampton.ca/EN/Business/BEC/resources/Documents/What%20is%20a%
20Standard%20Operating%20Procedure(SOP).pdf
 Allen L. V and Ansel H. C. (2014). Ansel’s Pharmaceutical Dosage Forms and Drug
Delivery Systems. Philadelphia: Lipincott Williams and Wilkins.
 Dash, A. K., Singh, S. and Tolman, J. (2014). Pharmaceutics – Basic Principles and
Application to Pharmacy Practice. USA: Academic Press. 
 Ennis, B. J. and Litster, J. D. (1997). Particle enlargement. In R. Perry and D. Greens
(Eds.), Perry’s Chemical Engineer’s Handbook. 7th ed. (pp 20-89). New York:
McGraw Hill.
 Ghosh, T. K. and Jasti, B. R. (2005). Theory and Practice of Contemporary
Pharmaceutics. USA: CRC Press LLC. 

42