Industrial training report for pharmacy student.

1. Page | 1
INDUSTRIAL TRAINING REPORT
ON
“TABLET, CAPSULE, ORAL LIQUIDES PACKAGING AND QUALITY CONTROL”
AT
GLUCONATE HEALTH LIMITED
Submitted in partial fulfilment of the requirements
For the award of degree of
Bachelor of Pharmacy
Submitted To: - Mrs. Koyel Kar Submitted By: - Sandeep Jana
Roll- 20101918033
B.C.D.A College of Pharmacy & Technology
Hridaypur, Barasat, Kolkata, 700127
Affiliated To
Maulana Abul Kalam Azad University of Technology

2. Page | 2
DECLARATION
I hereby declare that the industrial project work embodied in this entitled, carried out by me
under the supervision of work manager of Gluconate Health limited.
I am indebted to my institutional guide, Mrs. Koyel Kar, for their step-by-step guidance
throughout the preparation of Industrial training report.
Date: 9th
March 2021
Sandeep Jana

3. Page | 3
ACKNOWLEDGEMENT
I am very thankful to production manager of Gluconate Health Limited Pharmaceutical
Company for giving me permission for the training.
I want to give a lot of thanks to Production manager, Quality control manager, and all the
chemist and workers of GHL for their generous co-operation.
I am greatly thankful to Dr. N. N. Bala (Principal of BCDACPT) and Mrs. Koyel Kar
(assistant professor of BCDACPT) for giving me a chance to perform the industrial training.
Thanking you
Sandeep Jana
B. Pharm (3rd
year)
Roll- 20101918033
B.C.D.A College of Pharmacy & Technology
Hridaypur

4. Page | 4
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 four-year integrated degree course of BACHELOR OF
PHARMACY each student has to undergo practical training for a period of few days in
various pharmaceuticals companies in India. As it is to be done completing B. Pharm course.
I was directed to undergo the 3rd year training at GLUCONATE HEALTH LIMITED. and
this report contains a brief description of the above pharmaceutical industry which was
observed during the training program.

5. Page | 5
CONTAINTS
Page no.
company profile 6
1. Tablet section
i. Tablet 10
ii. Ingredients used in tablet 11
iii. Tablet production method 12
iv. Instruments used in tablet production 16
v. G.H.L product list 19
2. Capsule section
i. Capsule 21
ii. Type of capsule 21
iii. Additives 23
iv. Manufacturing of Hard Gelatine Capsule 24
v. Filling of Hard Gelatine Capsule 24
vi. G.H.L product list 25
3. Oral liquid section
i. Oral liquid 27
ii. Components of oral liquid 27
iii. Manufacturing process of oral liquid 28
iv. Instruments used in oral liquid formulation 29
v. G.H.L product list 31
4. Quality control
i. Quality assurance & Quality control in pharma industry 33
ii. Quality control work (summary) 34
iii. Quality control department 34
iv. Chemical section 36
v. Instrumental section 37
vi. Micro- biological section 42
5. Packaging
i. Packaging and its type 45
ii. Purpose of packaging and package label 46

6. Page | 6
COMPANY PROFILE
Gluconate Health Limited is situated in Dumdum Cantonment, Health Institute Road and the
registered head office is at 2, Durga Charan Doctor Lane, Kolkata- 700014, West Bengal.
The first chief Minister of West Bengal and the great visionary Dr. Bidhan Chandra Roy’s
effort discover anti- malarial drug from ‘Chhatim’ tree (Astonia scolaris), culminated to the
foundation of the pharmaceutical manufacturing company Gluconate India Limited in 1933.
Following this in 1936 some young ambitious medical practitioner formed Indian Health
Institute Limited, to manufacture Vaccine, Tablet, Capsules, and Liquids. Gluconate India
Limited and Indian Health Institute Limited were merged and in 1990 and Gluconate Health
Limited were formed on the principle of ‘having best of both’.
Since 1987 both these companies have been nationalised and presently Gluconate Health
Limited is wholly owned enterprise under Government of west Bengal, which contrary to the
popular belief about government run companies are likely to be unhealthy, Gluconate Health
Limited stands out proudly and have shown steady growth and profit with promise to grow
high in coming years. We have always extended our active effort to ensure the success of any
healthcare programme taken by the Government at any level and our community towards this
are always on priority. We are a major player in the country in supplying essential medicines
at most affordable price to various Government bodies. We have achieved commendable
success by suppling our high-quality medicines to ensure the success of “women and child
development programme” under UNDP.
We supply a large number of our products in high-quality to Government of West Bengal,
Bihar, Jharkhand, Chhattisgarh, Tripura, Andhra Pradesh, PGI Chandigarh, ICDS, various
Government of India Health Care programme and many more reputed institutions.

7. Page | 7
GENERAL INDUSTRY RULE
Protective procedure: including-
• Tying long hair back, wearing personal protective equipment’s (eye protection, coats,
closed shoes; glasses may be preferred to contact lenses), and using such equipment’s
in appropriate conditions.
• Always using appropriate pipetting devices and understanding that mouth pipetting is
forbidden.
Machine operation:
• Never use any machine unless you have been trained on its operation by a lab stuff
member and are aware of its safe use.
• If you have any question do not hesitate to ask any stuff member.
• Report any malfunctioning equipment to lab stuff. Do not use any equipment that is
not working properly. Notify others by placing an out of order sign at the machine.
Other Guidelines:
• Read and fully comprehend the lab procedure as set fourth in the lab manual before
you begin any experiment. If you do not understand the procedure, see your
instructor/TA.
• Never eat or drink in the laboratory.
• Washing hands prior to and following laboratories and at any time contamination is
suspected.
• Never use compressed air to clean machinery, skin or clothing.
• Students are required to clean up using vacuums, brooms, and dust pan.
• Clean up any spilled liquids. If it is a potentially hazardous or oily liquid, then contact
lab stuff so that they may respond with appropriate measures.
Emergency Guidelines:
Have the following information ready when speaking to the public safety dispatcher:
• Nature of emergency
• Location (building and room number)
• Number of people involved / injured
Fire alarm
• All building occupants must exit the building when the fire alarm is activated. (do not
use elevators).

8. Page | 8

9. Page | 9
TABLET SECTION

10. Page | 10
TABLET SECTION
TABLET:
Tablet is a unit solid oral dosage form containing one or more active ingredients with or
without suitable excipients.
Advantages:
• Production aspects:
▪ Large scale production at low cost.
▪ Easiest and cheapest to package and ship
▪ Highly stable
• User aspect:
▪ Easy to handling
▪ Light and compact
▪ Great dose precision and least content variability
▪ Coating can mask unpleasant teste and odour and improve pharmaceutical
elegance
Disadvantage:
▪ Some drug resist compression into dense compacts.
▪ Drugs with poor wetting, slow dissolution, intermediate to large dosages may be
difficult or impossible to formulate and manufacture as a tablet that provide adequate
or full drug bioavailability.
▪ Bitter taste drugs, drugs with an objectionable odour, or sensitive to oxygen or
moisture may require encapsulation or entrapment prior to compression or the tablets
may require coating.
Types of tablets:
1. Route of administration:
▪ Oral tablet
▪ Sublingual or buccal tablet
▪ Vaginal tablet
2. Production process
▪ Compressed tablet
▪ Multiple compressed tablet
➢ Tablet with in a tablet: core and shell
➢ Protect tablet from moisture, mask odour and taste.
▪ Chewable tablet
➢ rapidly disintegrates, and provide fast action.
▪ Effervescent tablet

11. Page | 11
Ingredients Use in Tablet Formulation:
1. Drug of active pharmaceutical ingredient
2. Diluents or bulking agent
✓ To make reasonably sized tablet, i.e., increase tablet mass.
3. Binders
✓ To bind powders in wet granulation process.
✓ To bind granules during compression.
4. Disintegrates
✓ To promote breakup and rapid release of drug from tablet.
5. Lubricants
✓ To improve the flow property of the powders.
✓ To reduce the friction during tablet ejection between the wall of the tablet and
the wall of the die cavity.
6. Glidants
• Reduce friction between the particles, and improve the flow property of the
granules.
7. Antiadherants
• To prevent adherence of the granules to the punch face and dies.
8. Dissolution (enhancer & retardants)
9. Wetting agents
10. Antioxidants
11. Preservatives
12. Colouring agents
13. Flavouring agents
Direct compression diluents:
Common materials that have been modified in the chemical manufacturing process to
improve fluidity and compressibility.
1. soluble diluents:
a. Lactose
• Spray dried lactose
• Fast-Flo lactose
• Tabetose: agglomerate form of lactose
• Anhydrous lactose: free flowing crystalline lactose

12. Page | 12
b. Sucrose
• Di-Pac: co-crystallization of 97% sucrose and 3% modified dextrin
• Nutab: 95.8% sucrose and 4.2% converted sugar
c. Dextrose
• Emdex: spray crystalized
d. Sorbitol
e. Mannitol
f. Maltodextrin
• Maltrin
2. Insoluble diluents:
a. Starch
• Starch 1500
• Era-Tab: spray dried rice starch
b. Cellulose
• Microcrystalline cellulose
c. Inorganic calcium salt
• Dicalcium phosphate (Di-Tab)
• Tricalcium phosphate (Tri-Tab)
Essential Properties of Tablet
• Accurate dosage of medicament, uniform in weight, appearance and diameter.
• Have the strength to withstand the rigors of mechanical shocks encountered in its
production, packaging, shipping and dispensing.
• Release the medicinal agents in the body in a predictable and reproducible manner
• Elegant product, acceptable size and shape.
• Chemical and physical stabilities
Tablet production
Powders intended for compression into tablets must possess two essential properties-
• Powder fluidity:
▪ The material can be transported through the hopper into the die.
▪ To produce tablets of a consistent weight.
▪ Powder flow can be improved mechanically by the use of vibrators,
incorporate the Glidants.

13. Page | 13
• Powder compressibility:
▪ The property of forming a stable, intact compact mass when pressure is applied.
Tabletting methods
▪ Dry method
• Direct compression
• Dry granulation
▪ Wet method
• Wet granulation
1. Direct compression
• Tablets are compressed directly from powder blends of the active
ingredient and suitable excipients.
• No pre-treatment of the powder blends by wet or dry granulation
procedures is necessary
Drug
Diluents
Disintegrates Blending Compression
Lubricant
Glidants
Example: ibuprofen, chewable antacid tablet
Advantages:
• Machine: fewer manufacturing steps and pieces of equipment.
• Labour: reduce labour costs.
• Less process validation. Lower consumption of power.
• Each primary drug particle is liberated from the tablet mass and is available for
dissolution.
• Disintegrate rapidly to the primary particle state.
• Fewer chemical stability problems would be encountered as compared to those
made by the wet granulation process.

14. Page | 14
Disadvantage:
• Problems in the uniform distribution of the low dose drugs.
• High dose drugs have high bulk volume, poor compressibility and poor
flowability are not suitable for direct compression.
• The choice of excipients are extremely critical. Direct compression diluents and
binders must posses both good compressibility and flowability.
• Many active ingredients are not compressible either in crystalline or in amorphous
form.
• Direct compression blending may lead to un even blending due to difference in
particle size and density.
• Direct compression equipment are expensive.
2. Wet Granulation:
Wet granulation is a process of using a liquid binder or adhesive to the powder
mixture. The amount of liquid can be properly managed, and over wetting will cause
the granules to be too hard and under wetting will cause the granules to be too soft
and friable. Aqueous solutions have the advantage of being safer to deal with than
solvents.
Drug
Blending
Diluents
Adhesive
Wetting
Water
Granulation
Drying
Lubricants
Glidants Sizing
Disintegrants
Blending
Compression

15. Page | 15
Advantages:
• Uniform mixing and better content uniformity
• More binding in less quantity of binder
• Suitable for very low to very high drug content
• Reduce sticking of blend to compression tool
Disadvantage:
• Not suitable for moisture sensitive product
• Time consuming because of involvement of additional unit operation of drying
3. Dry Granulation:
This process is used when the product needed to be granulated may be sensitive to
moisture and heat. Dry granulation can be conducted on a press using slugging tooling
or on a roller compactor commonly referred to as a chilsonator. Dry granulation
equipment offers a wide range of pressure and roll types to attain proper densification.
However, the process may require repeated compaction steps to attain the proper
granule end point. Also called as “Pre-compression” or “Slugging” method.
Drug
Diluents Blending
Lubricants
Pre-compression
Comminution
Glidants
Lubricants sizing
Disintegrants
Blending
Compression
Example: Aspirin, vitamins etc.

16. Page | 16
Advantages:
• Suitable for moisture and temperature sensitive API
• Suitable for low to high drug content
• Time and cost effective, as unit operation of drying not involved
Disadvantages:
• High force involve in compaction, may result in hardening of tablet.
• Greater chances of generation of dust and environmental contamination
Importance of granulation:
• To impart good flow properties to the material
• To increase the apparent density of the powders
• To change the particle size distribution
• Uniform dispersion of active ingredient.
Instrument for Granulation
Blending:
Powders to be used for encapsulation or to be granulated must be well blended to
ensure good drug distribution. Inadequate blending at this stage could result in
discrete portion of the batch being either high or low in potency. Steps should also be
taken to ensure that all the ingredients are free of lumps and agglomerates. For these
reasons, screening and/or milling of the ingredients usually makes the process more
reliable and reproducible.
Equipment used for blending:
• V-blender.
• Double cone blender.
• Ribbon blender.
• Slant cone blender.
• Octagonal blender.

17. Page | 17
Sieving:
Separation of a mixture of various-sized particles, either dry or suspended in a liquid,
into two or more portions, by passing through screens of specified mesh sizes.
Importance of sieving
• The sieving process gives three fractions of granules:
• Very coarse granules, which return back to the milling process.
• Very fine fraction, which return back to the compaction.
• Fraction with optimal dimensions for following manufacturing steps.
Equipment used for sieving
• Industrial Sifter and Sieving Machine
Dryer:
In the pharmaceutical sector the fallowing dryers are use:
• Rotary Drier,
• Fluidized Bed Drier,
• Vacuum Oven,
• Spray Drier,

18. Page | 18
Other instruments used in tablet manufacturing are as follows:

19. Page | 19
Evaluation of tablets: -
• Appearance,
• Content of active ingredient in the tablets,
• Uniformity of weight,
• Size and shape,
• Organoleptic properties,
• Uniformity content,
• Hardness and friability test,
• Disintegration test,
• Dissolution,
List of Tablet manufactured:
SL.NO NAME OF PRODUCTS PKG DISCRIPTION
1 Azithromycin 500mg 10*10’s Antibiotic
2 Norfloxacin 400mg 10*10’s Antimicrobial
3 Paracetamol 500mg/ 650mg 10*10’s Antipyretic
4 Ibuprofen 200mg/ 400mg 10*10’s Analgesic
5 Metronidazole 200mg/ 400mg 10*10’s Anti-amoebic
6 Ranitidine 150mg 10*10’s Anti-ulcer

20. Page | 20
Capsule section

21. Page | 21
Capsule section
Capsule:
Capsule is solid dosage forms in which one or more medicinal and or inert substances
are enclosed within a small shell or container generally prepared from a suitable form
of gelatine. Depending upon their formulation, the gelatine capsule shells may be hard
or soft.
Characteristics:
• May be inserted into the rectum for drug release and absorption from the site.
• The contents may be removed from the gelatine shell and employed as a pre
measured medicinal powder, the capsule shell being use to contain a dose of the
medicinal substance.
• Elegance.
• Ease of use.
• Portability.
• Tasteless shell to mask the unpleasant taste/odour of the drug.
• Permits physician to prescribe the exact medication needed by the patient.
• Easily taken.
• tasteless when swallowed.
• Commonly embossed or imprinted on their surface the manufacturer’s name and
product code readily identified.
Components of Capsules:
• Gelatine.
• FD & C and D & C colorant.
• Sugar.
• Water - 12 to 16 % but may vary depending on the storage condition.
• Sulfur dioxide (.15%) - prevent decomposition during manufacture.
• Opaquants/Opacifying agent - titanium dioxide.
Types of Capsule:
Two main types of capsules are-
1. Soft gelatine capsule:
In 1834, Mothes and Dublanc were granted a patent for a method to produce a
single-piece gelatine capsule that was sealed with a drop of gelatine solution.
They used individual iron moulds for their process, filling the capsules
individually with a medicine dropper. Later on, methods were developed that
used sets of plates with pockets to form the capsules. Although some
companies still use this method, the equipment is not produced commercially
any more. All modern soft-gel encapsulation uses variations of a process
developed by R.P. Scherer in 1933. His innovation was to use a rotary die to
produce the capsules, with the filling taking place by blow moulding. This
method reduced wastage, and was the first process to yield capsules with
highly repeatable dosage.

22. Page | 22
Cod liver oil soft gelatine capsule
2. Hard Gelatine Capsule:
Two-part hard gelatine capsule. Also referred to as “DFC” Dry Filled Capsule.
Manufactured into two sections, the capsule body and a shorter cap. A recent
innovation in capsule shell design is the Snap-Fit, Coni-Snap, and Coni Snap Supro
hard gelatine capsules.
Capsule size:
For human use, empty capsules ranging in size from 000 the largest to 5 the smallest.
Generally, hard gelatine capsule are used to encapsulate between 65 mg to 1 gram.
Characteristic:
• Usually use in the extemporaneous compounding of Rx.
• Made of gelatine, sugar, and water.
• Clear, colourless and essentially tasteless.
• Coloured with various FD & C and D & C dyes and made opaque by adding
agents such as titanium dioxide.
Combination of colorants and Opaquants to make them distinctive, many with caps
and bodies of different colours.

23. Page | 23
Plasticizers: -
• The amount of plasticizers used to make the capsule to hard or soft.
• The plasticizers are used – Glycerine, Sorbitol.
Preservatives: -
• If included, is generally a mixture of Methylparaben (4part) and
Propylparaben (1part) to the extent of 0.2%.
Flavours:
• If added, should not exceed 2%.
• Generally, the flavours are used- Ethyl vanillin or essential oils.
Sugar: -
• If included, may be up to 5% to give the gelatine shell desirable chewable
characteristics.
Additives: -
a) Diluents: -
• The diluents have to be added to bring the medicament up to a desired
bulk.
• The quantities of diluents are related to the dose of the medicament and the
capsule size.
b) Protective sorbents: -
• Sometimes some inert materials are included to prevent the absorption of
moisture by hygroscopic substances.
• Materials like – oxides and carbonates of Mg or Ca.
c) Glidants: -
• Glidants become essential when the powders are filled by automated
machinery requiring their regular flow in the capsule bodies.
• Glidants like- Talc, Stearates.
d) Anti-dusting compounds: -
• These are the compounds which prevent the flow of dust particle of the
drug in the air to causes health hazards.
• Anti-dusting compounds like- inert edible oils.
Gelatine:
• It is obtained by the partial hydrolysis of collagen obtained from skin,
white connective tissue and bones of animals.
• Available in the form of a fine powder, a coarse powder, shreds, flakes, or
sheets.
• Stable in air when dry but when become moist - subject to microbial
decomposition.
• Extreme dryness- capsules may become brittle and crumble.

24. Page | 24
Manufacturing of Hard Gelatine Capsule:
• Manufactured into 2 sections, the capsule body and the shorter cap.
• The 2 parts overlap when joined, with the cap fitting snugly over the open end of the
capsule body.
• Shells are produced by chemical dipping of pins or pegs of the desired shape and
diameter into a temperature-controlled reservoir of melted gelatine mixture.
• The pegs made of manganese bronze, are affixed to plates, each capable of holding up
to about 500 pegs.
• Each plate is mechanically lowered to the gelatine bath, the peg sub-merge to the
desired depth and maintained for the desired period to achieve the proper length and
thickness of coating.
• The plate and the pegs are slowly lifted from the bath and the gelatine dried by a
gentle flow of temperature-and humidity-controlled air.
• When dried, each capsule part is trimmed mechanically to the proper length and
removed from the pegs, the capsule bodies and caps are joined.
Filling Hard Capsules Shells:
1. Punch Method
• Powder is placed on a sheet of a clean paper or porcelain plate.
• Using spatula - formed into a cake having a depth of approximately one-fourth to
one third the length of the capsule body.
• Then empty capsule body is held between the thumb and forefinger and punched
vertically into the powder cake repeatedly until filled.
2. Feton capsule filling
• With empty capsule in the loader tray, the tray placed on top of the filler unit.
• The loader inserts the capsules into the filling unit and is removed, and the top
plate is lifted to separate the caps from the bodies.
• The powder is placed on the unit and the capsule bodies filled.
• The top plate is returned to the unit and the caps placed on filled capsule bodies.
Semi-automatic capsule filling machine

25. Page | 25
Evaluation of capsules: -
• Uniformity of weight.
• Content of active ingredients in capsules.
• Disintegration.
• Dissolution.
List of Capsules manufactured:
SL.NO. NAME OF THE PRODUCTS PKG DESCRIPTION
1 Amoxycillin 250mg 10*10’s Antibiotic
2 Ciprofloxacin 250mg/ 500mg 10*10’s Anti-microbial
3 Ampicillin + Cloxacillin 250mg 10*10’s Antibiotic
4 Rifampicin 450mg 10*10’s Anti-T.B.

26. Page | 26
Oral liquids section

27. Page | 27
Oral Liquid Section
Oral Liquid:
Oral liquid is a liquid preparation that contains one or more soluble active pharmaceutical
ingredient’s in a specific solvent.
Advantages:
• Immediately available for absorption.
• Easy to administration.
• Easy to colour, flavour, sweeten.
• Easy to change the dose.
Disadvantages:
• Bulky than tablet or capsules, so difficult to carry.
• Less stable.
• Better incompatibility than solid dosage forms.
• Less accuracy in dose.
• Accident breakage of container.
Classification of oral liquid dosage form:
1. Monophasic: - simple syrup, drops, elixirs.
2. Biphasic: -
• Suspension
• Emulsion
Components of liquid oral solution’s:
• Vehicle(solvent): – purified water, oil.
• Co-solvent: – e.g., Propylene glycol, Glycerol, Ethanol.
• Surface-active agents: - to enhance the solubility of API in solvent.
• Preservatives: - to inhibit microbial growth.
• Sweetening agents: - e.g., Glucose, saccharin, aspartame.
• Viscosity modifier: - e.g., cellulose derivatives.
• Antioxidants: - e.g., butylated hydroxytoluene
• Colouring and flavouring agents
• Buffering agents: - to maintain the pH of the formulation.

28. Page | 28
Manufacturing process of liquid orals

29. Page | 29
Instruments used in oral liquid preparation:

30. Page | 30

31. Page | 31
Evaluation of Oral liquids:
• Uniformity of volume
• Content of active ingredient in oral liquid
• pH of the oral liquid
• stability of the formulation.
List of Oral liquids manufactured
SL.NO. NAME OF THE PRODUCT PKG DISCRIPTION
1 Metronidazole suspension 60ml Amoebicidal
2 Paracetamol syrup 60ml Antipyretic
3 Syrup Molar sodium lactate 450ml Oxidant
4 Gention violet 100ml Dermatological agent
5 Erythromycin suspension 60ml Anti-microbial agent
6 Alkacitron 100ml Urinary infection
7 Glucorex 100ml Expectorant
8 Zymoton 100ml Digestive enzyme
9 B com T 200ml Vit B

32. Page | 32
Quality control section

33. Page | 33
Quality control
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.
Quality Assurance (QA) Management Procedure:
1. 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.
2. Quality Documentation Management and Change Control:
• This SOP describes how to generate new quality documents or change control of
existing documents, review of quality documents, satellite file management, and
role of document author, approver, document control officer and satellite file
administrator.
3. Documentation Rule for GMP Documents:
• This SOP describes the principles to be followed in GMP documents, entry of data
and information, signature requirements and correction technique of incorrectly
entered data or information.
4. Quality Documentation-Control, Tracking and Distribution:
• In this SOP you will find mainly the role of document control officer during the
initiation, creation, circulation and approval of new quality related documents.
• It also describes the procedure of modification and review of existing document
using a documentation database.
• Management of existing and superseded documents is also a part of this
procedure.
• You will see all the forms referred during the instruction are attached at the end of
the procedure.
5. Shelf Life of Product:
• This simple SOP describes the meaning of shelf life and provides on how to
interpret shelf lives and storage conditions for your raw materials from the
Certificate of Analysis, determining expiry date for your finished products by use
of raw material date of manufacturing and their shelf lives.

34. Page | 34
Quality Control work (Summary)
Sampling of active pharmaceutical ingredients, Excipients, finished product & packing
material etc.
• Testing of API (Active Pharmaceutical Ingredients).
• Testing of excipients.
• Testing of sample process.
• Testing of finished products.
• Testing of packing material.
• Stability studies of finished product.
• Maintenance and calibration of instruments.
• Procurement of chemicals and glass ware.
• Procurement of reference standard.
• Procurement of maintenance of clusters for microbiological testing.
• To certificate analysis.
• To study products complaints.
• To destroy the control sample after six month of the date of expiry.
Quality control department:
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.
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, Q C office.
• To carry out stability testing etc.
• Instrument maintenance and calibration.
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.

35. Page | 35
4. Quality control office:
Responsibilities: -
• To make certificate of analysis of R.M. &finished products.
• To maintain & keep records of analysis & certificate of analysis.
Working of Quality control:
Introduction:
This the section essential for the quantitative & qualitative evolution of the raw
material provided by supplier, mixture material during processing & finished product
evaluation supplied by chief manufacturing chemist. Here also sample of finished
batches are regularly checked for their validation. It consists of 3 sections-
1. Chemical section.
2. Instrumental section.
3. Micro-biological section.

36. Page | 36
1. Chemical section: -
In this section evaluation of drug, elemental analysis, mineral analysis, extraction,
ignition, loss on dying, melting point recording processing are carried out by
following instruments-
a) Test tubes, Boiling tubes, Pipette, Funnel, Beaker, Burette, Separating funnel
• These are made up of borosilicate glass.
• Pipettes are available from 1.50 ml.
• Ammonia distillation test apparatus, boiling point apparatus are also
available.
• Separating funnels are from 250-500 ml.
(A) Burette. (B) Pipette (C) Separating funnel
b. Kipp’s apparatus: -
Used ferrous sulphide with sulphuric acid to prepare hydrogen sulphide used
for elemental analysis.
Kipp’s apparatus
C. Melting point detector: -
Reads up to 500 C and is automatic electric heater melting is observed through
a lens.

37. Page | 37
Other instrument’s that are used are as follows:
Magnetic stirrer Water bath
Muffle Furness Vacuum Oven
Reagent used in analysis – acid, base.
• Acids. e.g. - Sulphuric acid, HCl, Nitric acid etc.
• Bases. e.g. - NaOH, KOH etc.
• Others e.g. – Distilled water, alcohol, Chloroform, Acetone, carbon
tetrachloride, Benzene Pyridine etc.
• Salts e.g. – Ammonium chloride, Na EDTA, Sodium acetate, calcium chloride
etc.
• Gases. e.g. – Hydrogen Sulphide
2. Instrumental section: -
In this section quantitative analysis of drugs, drug release extent specific
rotation moisture content determination, TLC spot study, colony counting,
bone of inhabitation determination etc. processes are carried out with
following instrument
a. Electronic Balance
• For the weight variation testing of solid dosage form we randomly collect
10-20 tablets and weighting it and determine average weight of each
tablets. It should not be less than 90% of the required weight and not more
than 110%.
• Weighing range is 1-100 mg.
• It is used to weighing accurately the drug in small amount.

38. Page | 38
Electrical Balance
b. Friability tester:
• This test is done for the knowing the amount of tablet is loss during the
transportation by the friction with the packing or during the manufacturing
process. The friability for tablet is not more or less than 10% of the actual
weight.
Friability tester
c. Hardness tester:
• Hardness is the main factor which effects the disintegration & dissolution
time.
• For the hardness testing generally hardness tester is used.
Tablet hardness tester: Pfizer type

39. Page | 39
d. UV-Spectrophotometer:
Infrared spectroscopy is one of the most powerful techniques of chemical
identification. The infrared region of the electromagnetic spectrum may be
divided into three main sections: -
a) Newer infrared
b) Middle infrared
c) Far infrared
The main region of interest for analytical purposes is from 2.5 to 25 um i.e.
4000 to 400cm-1 I.R. spectra originate from the different modes of variation
and rotation of a molecules at wave length bellow 25 um the radiation has
sufficient energy to caves changes in the variation energy level of the
molecules and these are accompanied by change rotational energy level.
Spectrophotometer
e. Digital pH meter:
• It is a device that consists of a glass electrode with very sensitive glass
membrane that changes the potential rapidly with variation in H+ ion
concentration in the dipping solution.
• This change in the potential recorded by recorder and is transformed in the
form of pH.
• The instrument is calibrated at pH=4 (Potassium hydrogen phthalate
buffer), pH=7 (Citro phosphate buffer), pH-9.2 (Borax buffer). It has a
tolerance limit of +0.05 (pH).
Digital pH Meter

40. Page | 40
f. Dissolution test apparatus:
• Drugs released from the capsules are sometimes suspension in dissolution
media is estimated with this instrument.
• At least 70% of the drugs should be released in 45 min.
• Example- Amoxicillin (water medium), Piroxicam (Dissolution media of
pH- 6.5 Phosphate Buffer).
Dissolution Test Apparatus
g. Disintegration apparatus:
• For the drugs like sionate capsule (B-complex), Amiclox (Ampicillin &
Cloxacillin), cephalic (folic acid & ferrous sulphate), follifer (Ferrous
fumarate & folic acid, vitamin – B12) etc.
• Dissolution test are not specified in standard book hence disintegration test
is carried out.
• Water is used only as dissolution media.
• To pass this test sample must dissolved within 15 min. without leaving any
clot in the tube.
Disintegration Apparatus
h. Polarimeter: -
• It is used for determine the purity, concentration and qualitative evaluation
of drugs by determining the specific rotation of the drug.
• The drugs evaluated by this instrument are Chlorpheniramine, Ampicillin,
and Amoxicillin etc.

41. Page | 41
i. High Pressure Liquid Chromatography:
High Performance Liquid Chromatography
Apparatus: - A liquid chromatography consists of a reservoir containing the mobile
phase a pump of force the mobile phase throw the system at high pressure and injector
to introduce the sample into the mobile phase, chromatography column, detector, a
data collection device.
Pumping system: - HPLC pumping system deliver major amount of mobile phase
from the solvent reservoirs to the column through the high-pressure tubing and fitting.
Injector: - After dissolution in mobile phase is other suitable solution compounds to
be chromatographer are injected into the mobile phase either manually by syringe.
Columns: -For the most pharmaceuticals analysis separation is achieved by the
partition of compounds in the test solution between the mobile phase and stationary
phase.
Detectors: - HPLC method requires the use of detectors such as consist of a flow
through sale mounted at the end of the column.
Data collection device: - Modern data station received and store detector output and
print variables.
j. UV-Light box: -
• It is close box with door and a UV protective glass window fitted with an
UV lamp & Visual lamp. In this TLC chromatogram are observed in visual
light range, upper UV range and lower UV range while switching
corresponding buttons respectively.
UV Light Box

42. Page | 42
3. Micro-biological section: -
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 vapours 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.
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 prevents 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 windows 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 in micro manipulation processes.
Auto Clave Laminar flow bench

43. Page | 43
d. 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 & autoclaves.
e. 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.
Microbial Colony Counter Digital Antibiotic Zone Reader

44. Page | 44
Packaging section

45. Page | 45
Packaging Section
Packaging is the science, art and technology of enclosing or protecting products for
distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation,
and production of packages. Package labelling or labelling is any written, electronic, or
graphic communications on the packaging or on a separate but associated label.
Types of packaging:
There are two types of packaging-
1. Primary packaging.
2. Secondary packaging.
1. PRIMARY PACKAGING: -
It is the packing which is in contact with medicament (capsule or tablet).
a) Blister packaging: -
• In this PVC and Al Foil is used for packaging.
• Sometimes Al foil is used wholly for packaging-
✓ Thickness of Al foil = 0.025mm ± 10%.
✓ Thickness of PVC = 0.25 mm ±10%.
• The blister package is formed by heat- softening a sheet of thermoplastic
resin and vacuum drawing the softened sheet of plastic into a contoured
mold.
Blister packaging machine consist of-
➢ Feeder (vibrator).
➢ A guide track.
➢ A forming die.
➢ Forming heater.
➢ Sealing heater.
➢ Cutter.
➢ Printing registration controller.
Blister Packaging
TEMPRATURE: -
▪ Forming heater = 140º-170º C.
▪ Sealing heater = 170º-200º C.

46. Page | 46
2. SECONDARY PACKAGING: -
It is the packaging which is in contact with the primary packaging.
It involved –
• Cartoons (printed).
• Corrugated boxes (CB).
• White board box.
• Corrugated boxes consist of 3 ply or 5 ply or 7 ply as per requirement.
• When secondary packaging is complete a BOPP tape (Bio Oriented Poly
Propylene Tape) is use for sticking.
The purposes of packaging and package labels:
Packaging and package labelling have several objectives:
Physical protection - The objects enclosed in the package may require protection from,
among other things, shock, vibration, compression, temperature, etc.
Barrier protection - A barrier from oxygen, water vapor, dust, etc., is often required.
Permeation is a critical factor in design. Some packages contain desiccants or Oxygen
absorbers to help extend shelf life. Modified atmospheres or controlled atmospheres are also
maintained in some food packages. Keeping the contents clean, fresh, and safe for the
intended shelf life is a primary function.
Containment or agglomeration - Small objects are typically grouped together in one
package for reasons of efficiency. For example, a single box of 1000 pencils require less
physical handling than 1000 single pencils. Liquids, powders, and granules need
containment.
Information transmission - Packages and labels communicate how to use, transport,
recycle, or dispose of the package or product. With pharmaceuticals, food, medical, and
chemical products, some types of information are required by governments.
Marketing - The packaging and labels can be used by marketers to encourage potential
buyers to purchase the product. Package design has been an important and constantly
evolving phenomenon for several decades. Marketing communications and graphic design
are applied to the surface of the package and (in many cases) the point-of-sale display.
Convenience - Packages can have features which add convenience in distribution,
handling, stacking, display, sale, opening, reclosing, use, and reuse.
Portion control - Single serving or single dosage packaging has a precise amount of
contents to control usage. Bulk commodities (such as salt) can be divided into packages that
are a more suitable size for individual households. It is also aids the control of inventory:
selling sealed one-litter-bottles of milk, rather than having people bring their own bottles to
fill themselves.

47. Page | 47
Packaging machines:
A choice of packaging machinery includes, technical capabilities, labour requirements,
worker safety, maintainability, serviceability, reliability, ability to integrate into the
packaging line, capital cost, flexibility (change-over, materials, etc.), energy usage, quality of
outgoing packages, qualifications (for food, pharmaceuticals, etc.), throughput, efficiency,
productivity.
Packaging machines may be of the following general types:
➢ Blister packs, skin packs and Vacuum Packaging Machines.
➢ Bottle caps equipment, Over-Capping, Lidding, Closing, Seaming and Sealing
Machines.
➢ Cartooning Machines.
➢ Box, Case and Tray Forming, Packing, Unpacking, Closing and Sealing Machines.
➢ Cleaning, Sterilizing, Cooling and Drying Machines.
➢ Conveyors, Accumulating and Related Machines.
➢ Feeding, Orienting, Placing and Related Machines.
➢ Filling Machines: handling liquid and powdered products.
➢ Package Filling and Closing Machines.
➢ Form, Fill and Seal Machines.
➢ Inspecting, Detecting and Checkweigher Machines.
➢ Palletizing, Depalletizing, Unit load assembly.
➢ Product Identification: labelling, marking, etc.
➢ Wrapping Machines.
High speed conveyor with bar code scanner for sorting transport packages
Label printer applicator applying a label to adjacent panels of a corrugated box.

48. Page | 48
Conclusion
Gluconate Health Limited helped me to imbibe the detailed information about tablet section,
liquid section, capsule section, oral liquid section & packaging section.
This industrial training provided a valuable learning experience in the carrier exploration
process and gave us unexpected benefit. Now I have evaluated the class room taught facts
and ideas and applied them to the real-life situation. We came to know about many things
such as the GMP (Good Manufacturing Process), the Current Good Manufacturing Process
(CGMP), basic laboratory requirement for product validation, the variety of machine used
in the large-scale industries of medicine etc.
These and many other factors cause the enhance of my knowledge and have created a
lifelong interest to learning through an exposure to new educational experience.

49. Page | 49
References
1. Tablet-
❖ Pharmaceutics. The science of dosage forms design. (M.E. Aulton)
❖ The theory and practice of industrial pharmacy.
❖ Pharmaceutical dosage forms: Tablets. Volume 2.
❖ Pharmaceutical dosage forms and drug delivery systems.
❖ Pharmaceutical Manufacturing Handbook Production and Processes.
2. Capsule-
❖ L. Lachman, H.A. Lieberman, J.L. Kanig (1986). The Theory and Practice of
Industrial Pharmacy (Third Ed.). Lea & Fibiger, Philadelphia.
❖ http://www.wikipedia.org.
3. oral liquid-
❖ L. Lachman, H.A. Lieberman, J.L. Kanig (1986). The Theory and Practice of
Industrial Pharmacy (Third Ed.). Lea & Fibiger, Philadelphia.
❖ Pharmaceutical Manufacturing Handbook Production and Processes.
4. Quality control-
❖ Ashutosh kar, Pharmaceutical analysis, theory, methodology and drug assay,
volume 2.
❖ www.ich.org
❖ www.fda.gov