INDUSTRIAL TRAINING REPORT

For Partial Fulfilment of B. Pharm 6th Semester

Session 2023-2024

Dr. A.P.J Abdul Kalam Technical University

Rishi Ram Naresh College of Pharmacy Molnapur Dubari Mau

Submitted by: Submitted To:

Abhinav Maddheshiya Harikesh Yadav Sir

Roll no. 2110880500002 Associate Professor
B. Pharm 6th Semester Rishi Ram Naresh College of Pharmacy
Rishi Ram Naresh College of Pharmacy Molnapur Dubari ,Mau

Certificate

This is to certify that Mr. Abhinav Maddheshiya, student of Rishi Ram Naresh
College of Pharmacy Molnapur Dubari Mau. has been completed industrial training in
Alliaance Biotech Baddi. At during the period 1 month and submitted report on production
Department. This work has done originally by student under my supervision.
The industrial training was enriched with the knowledge & working culture of the respective
company.

Mr. Harikesh Yadav Sir

Associate Professor
RISHI RAM NARESH COLLEGE OF

PHARMACY MOLNAPUR DUBARI

MAU
 Declaration

I hereby declare that the industrial project work embodied in this entitled, carried out by me under
the supervision of executive of Alliaance Biotech Baddi.

I am in debated Institutional guide Mr. Harikesh Yadav Sir for their step by step guidance
through out the preparation of Industrial Training Report.

Abhinav Maddheshiya

B.Pharm 3rd year (6 semester)

Roll No. (2110880500002)

Rishi Ram Naresh College of Pharmacy

Molnapur Dubari Mau

 Acknowledgement

I am very thankful to executive Alliaance Biotech Baddi Pharmaceutical Company for giving
me permission for the Training.
I want to give a lot of thanks to executive, who supervised me for my future.
I have clean Information about every instrument and manufacturing procedure and analytical
methods. A special thanks to all staff and worker who cooperate me during the training period.

Thanking You:

Abhinav Maddheshiya
B.Pharm 3rd year (6 semester)
Roll No. (2110880500002)
Rishi Ram Naresh College of Pharmacy
Molnapur Dubari Mau
 Company Profile

Alliaance Biotech founded by Mr. Shiv Kumar Gupta and Mr. Shishir Gupta located in Baddi,
village Katha, Tehsil Nalagarh, District Solan, Himachal Pradesh towards Sai Road Baddi. The
firm built the premises to suit the Schedule-M norms and WHO norms attained the manufacturing
License in accordance with the aforesaid norms. The firm is licensed to manufacture the Drugs
Tablets, Capsules, Liquid, Injections (Dry & liquid), Hormone’s Tablets and injections. Alliaance
Biotech is ISO 9001:2008, head office located at Chandigarh, with activities mainly in the
manufacturing Pharmaceautical finished products.

We are committed to make the world a better place to live in and we strive to achieve this goal
through our educational, environmental and Personal healthcare programs.

Focused on the high-growth healthcare market, Alliaance Biotech has built the industry’s
broadest suite of products and services that help improve quality, safety and efficiency all along
the chain of care. With our unparalleled resources, expertise, we deliver integrated solutions that
are innovative and practical. To our customers, this means we help them focus on what matters
most – improving people’s lives.

Generics have become an absolutely critical component of the health care system as they save
consumers, insurers and other prescription drug buyers billions of rupees every year. Alliaance
Biotech is primarily focused on solid oral dose generic pharmaceutical products.

ADDRESS:

SC0 84, 2nd Floor, Swastik Vihar Sector 5, Mansa Devi Complex Panchkula, Haryana 134109

440/3 Village Katha, Baddi Himachal Pradesh 173205, India

 Contents

1. Tablet Section Page No.

Tablet 1

Types of tablet 2

Ingredients used in formulation 3

Tablet Production 4
Wet Granulation 5

Dry Granulation 6

Instrument used for granulation 7-8

Tablet Punching 9-10

Tablet Coating 11-13

2. Capsule Section Page No.

Capsule 14

Type of capsule 15

Size & Characteristic 16-17

Manufacture of hard gelatin capsule 18-20

Product list 21

3. Oral Liquid Page No.

Oral Liquid 22
Manufacturing of oral liquid 23
Evaluation of Oral Liquid 24
3. Quality control Page No.

Quality Control 25
Quality control work 26-28

4. Packing section 29-32

5.Conclusion 33
 TABLET SECTION
Tablet

A tablet is a mixture of active substances excipients, usually in powder form, pressed or compacted
into a solid. The excipients include binders, Glidants (flow aids) and lubricants to ensure efficient
tabletting, disintegrates to ensure that the tablet breaks up in the digestive tract; sweeteners or flavors
to mask the tasteof bad - tasting active ingredients; and pigments to make uncoated tablets visually
attractive. A coating maybe applied to hide the taste of the tablet's components, to make the tablet
smoother and easier to swallow, and to make it more resistant to the environment, extending its shelf
life.

Advantage
 Production aspect
 Large scale production at lowest cost
 Easiest and cheapest to package and ship
 High stabili
 User aspect (doctor, pharmacist, patien Easy to handling.)
 Lightest and most compact.
 Greatest dose precision & least content variability.

 Coating can mark unpleasant tastes & improve pt. acceptability.

Disadvantages

 Some drugs resist compression into dense compacts.

 Drugs with poor wetting, slow dissolution, intermediate to large dosages may
be difficult or impossible to formulate and manufacture as tablet that provide
adequate or full drug Bioavaila bility.

 Bitter taste drugs, drugs with an objectionable odor, or sensitive to oxygen or

moisture may requireencapsulation or entrapment prior to compression or the
tablets may require coating

1
Types of tablets-

1. Route of administration
a) Oral tablets,
b) Sublingual or buccal tablets,
c) Vaginal tablets,

2. Production process

a) Compressed tablets,

b) Multiple compressed tablets,

 Tablet within a tablets: core and shell, 

 Multilayer tablet Sugar coated tablets

 rotect tablets from moisture,
 Mask odor and flavor,

 Elegance, 

 Film coated tablets,

 Thin film coat,

 Soluble or insoluble polymer film, 

c) Chewable tablets
 Rapid disintegrate,
 Antacid, rapid action,
 Children drug,

d) Effervescent tablets
 Dissolve in the water before drink

Fig. 1 Absorption of Tablet

2
Ingredients used in tablet formulations

1. Drugs. -
 Main Active Pharmaceutical Ingreditents

2. Fillers, diluents, bulking agent -

 To make a reasonably sized tablet.

3. Binders -
 To bind powders together in the wet granulation process.
 To bind granule together during compression.

4. Disintegrates-

 To promote breakup of the tablets.

 To promote rapid release of the drug.

5. Lubricants
 To reduce the friction during tablet ejection between the walls of the tablet and
the walls of the die cavity.

6. Glidants
 Reducing friction between the particles.
 To improve the flow properties of the granulations.
7. Antiadherants
 To prevent adherence of the granules to the punch faces and dies.

8. Dissolution (enhancers and retardants)

9. Wetting agents
10. Antioxidants
11. Preservatives
12. Coloring agents
13. Flavoring agents

3
 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.

• Powder compressibility
The property of forming a stable, intact compact mass when pressure is applied.

Tabletting methods( Granulation )

• Dry methods
a) Direct compression

b) Dry granulation

• Wet methods
a) Wet granulation

1. Direct compression:-
 Drug

 Filler

 Disintegrates

 Binding

 Lubricant

 Glidant
 Compression

E.g.:- Nacl, Nabr, Kcl.

 Tablets are compressed directly from powder blends of the active ingredient and suitable
excipients.

4
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
wettingwill cause the granules to be too soft and friable. Aqueous solutions have the advantage of
being safer todeal with than solvents.

Fig. 2

5
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
Commonlyreferred to as a chilsonator. Dry granulation equipment offers a wide range of pressure
roll types toattain 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.

Fig. 3
E.g.:-Asprin vitamin.

Importance of granulation

1. To impart good flow properties to the material,

2. To increase the apparent density of the powders,

3. To change the particle size distribution,

4. Uniform dispersion of active ingredient.

6
Instrument for granulation

Fig. 4
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.

Fig. 5 Double cone blender

7
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.

Dryer
In the pharmaceutical sector the fallowing dryers are use:

1. Static Oven,

2. Rotary Drier,
3. Fluidized Bed Drier,
4. Vacuum Oven,

5. Microwave Drier,
6. Spray Drier,
7. Rotary Atomizer,

8. I.R Drier.

8
 TABLET PUNCHING

A tablet press is a mechanical device that compresses powder into tablets of uniform size and weight.
A press can be used to manufacture tablets of a wide variety of materials, including pharmaceuticals,
Illicit drugs, cleaning products, and cosmetics. To form a tablet, the granulated material must be
metered into acavity formed by two punches and a die, and then the punches must be pressed together

with great force to fuse the material together.

Tabletting procedure
• Filling,
• Compression,
• Ejection,
Tablet compression machines
• Hopper for holding and feeding granulation to be compressed.
• Dies that define the size and shape of the tablet.
• Punches for compressing the granulation within the dies.
• Cam tracks for guiding the movement of the punches.
• Feeding mechanisms for moving granulation from the hopper into the dies.
Single punch machine
• The compression is applied by the upper punch.
• Stamping press.

Fig. 6

9
 Fig. 7

Fig. 8

Multi-station rotary prosses

Fig. 9

The tablet pressing operation an old Cad mach rotary tablet press

10
 Tablets coating:

The coating in tablets, which is additional step in the manufacturing process.

Objectives:
 To makes the taste, odor, or color of the drug.
 To provide physical and chemical protection for the drug.

 To control the release of the drug from the tablet.

 To protect the drug from the gastric environment of the stomach with an acid resistant enteric
coating.

Coating Material

a) Polymer used in film coating

 Cellulose derivatives.
 Methacrylate amino ester copolymers.

b) Plasticizer used in film coating

 Polyols - Polyethylene glycol 400.
 Organic esters - diethyl phthalate.
 Oils/glycerides - fractional coconut oil.

c) Colorants used in film coating

 Iron oxide pigments.
 Titanium dioxide.
 Aluminium lakes.

Water insoluble pigments are more favourable than water soluble colours for the following reasons:
 Better chemically stability in light.
 Optimised impermeability to water vapour.
 Better opacity.

 Better covering ability. 

3. Press coating
Press coating process involves compaction of coating material around a preformed core. The
Technique differs from sugar and film coating process.

11
4. Functional coatings
Functional coatings are coatings, which perform a pharmaceutical function.
These include;

a) Enteric coating -

The pH status of enteric coated polymers in the stomach

The ideal properties of enteric coated material

b) Controlled release coatin

The ideal properties of enteric coated material

 Permeable to intestinal fluid.
 Compatibility with coating solution and drug.

 Formation of continuous film.

 Nontoxic.
 Cheap and ease of application.

 Ability to be readily printed.

 Resistance to gastric fluids.

Fig. 10

Fig. 11 Coating Machine

12
Polymer Trade name Application

Shellac EmCoat 120 N Enteric Coatings

Taste/Odor Masking
Marcoat 125

Cellulose acetate Aquacoat CPD® Enteric Coatings

Taste masking
Sepifilm™ LP
Sustained release coating
Klucel® Sub coat moisture and
Aquacoat® ECD barrier sealant pellet
coating
Metolose®

Polyvinylacetate phthalate Sureteric® Enteric Coatings

Methacrylate Eudragit® Enteric Coatings

Sustained Release
Coatings
Taste Masking
Moisture protection
Rapidly disintegrating
Films

Table 1

13
 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 gelatin. Depending upon their
formulation, the gelatin capsule shells may be hard or soft.

Characteristics:
1. May be swallowed whole by the patient.
2. May be inserted into the rectum for drug release and absorption from the site.
3. The contents may be removed from the gelatin shell and employed as a pre measured medicinal
powder, the capsule shell being use to contain a dose of the medicinal substance.
4. Elegance.
5. Ease of use.
6. Portability.
7. Tasteless shell to mask the unpleasant taste/odor of the drug.
8. Permits physician to prescribe the exact medication needed by the patient.
9. Conveniently carried.

10. Readily identified.

11. Easily taken.
12. tasteless when swallowed.
13. Commonly embossed or imprinted on their surface the manufacturer’s name and product code readily
identified.

Components of Capsules
1. Gelatin.
2. FD & C and D & C colorant.
3. Sugar.
4. Water - 12 to 16 % but may vary depending on the storage condition.

5. Sulfur dioxide (.15%) - prevent decomposition Du noy ring manufacture.

6. Opaquants/Opacifying agent - titanium dioxide.

Type of capsule
The two main types of capsules are-
1. Soft Gelatin or Soft Gel Capsule
2. Hard Gelatin Capsule

14
1-Soft gel encapsulation

Fig. 12 Cod liver oil soft gel capsules.

In 1834, Mothes and Dublanc were granted a patent for a method to produce a single-piece gelatin capsule
that was sealed with a drop of gelatin 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 molding. This method reduced wastage, and was the first process to yield capsules with highly
repeatable dosage.

1. HARD GELATIN CAPSULES

Fig. 13
Two-part hard gelatin 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 gelatin
capsules.
15
Capsule size

Fig. 14

Empty Hard Gelatin Capsule Physical Specifications

Height or Typical Fill Weights

Size Outer Locked Actual Vol.
(mg) 0.70
Diameter (mm) Length (mL)
(mm) Powder Density

000 9.91 26.14 1.37 960

00 8.53 23.30 0.95 665

0 7.65 21.70 0.68 475

1 6.91 19.40 0.50 350

2 6.35 18.00 0.37 260

3 5.82 15.90 0.30 210

4 5.31 14.30 0.21 145

5 4.91 11.10 0.13 90

Table 2

For human use, empty capsules ranging in size from 000 the largest to 5 the smallest. Generally, hard gelatin
capsule are used to encapsulate between 65 mg to 1 gram.

Characteristic
 Usually use in the extemporaneous compounding of Rx.

o Made of gelatin, sugar, and water.

o Clear, colorless and essentially tasteless.
o Colored with various FD & C and D & C dyes and made opaque by adding agents such as titanium
dioxide.
16
  Combination of colorants and Opaquants to make them distinctive, many with caps and bodies of
different colors.
Plasticizers:-

The amount of plasticizers used to make the capsule to hard or soft.

The plasticizers are used – Glycerin, Sorbitol.
Preservatives:-

If included, is generally a mixture of Methylparaben (4part) and Propylparaben (1part) to the

extent of 0.2%.
Flavors:-

If added, should not exceed 2%.

Generally the flavors are used- Ethyl vanillin or essential oils.
Sugar:-

If included, may be up to 5% to give the gelatin 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.
Gelatin
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.

17
 HGC contain 13 to 16 % of moisture.
Extreme dryness- capsules may become brittle and crumble.

Manufacture of Hard Gelatin 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 gelatin 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 gelatin bath, the peg submerge 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 gelatin dried by a gentleflow 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.

Capsules parameter as per I.P.

Product Dose Conversion (m.g.) Drug Dissolutio

(m.g. content (%) n (%)
)
amoxicillin 250 285 90-110 80

Ampicilline 250 287 92.5-104.5 75

Trihydrate
Cephalexin 250 270 90-110 75
Monohydrat
e
Doxycycline 100 116 90-120 65

Rifampicine 150 165 92.5-107.5 70

Table 3
Filling Hard Capsules Shells
1. Use 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,

18
Process Capsule Filling
1. Milling /Sieving of all Ingredients.
2. Blending Powder Blender / Empty Capsules.

3. Capsule Filler.
4. Capsule cleaner.
5. Capsule injection screen.

6. Capsule check-weighing system/reject.

7. Finished capsules.

Fig. 15 MAKING CAPSULECAP & BODY

Fig. 16. FILLING CAPSULE(MANUAL)

19
ProFill 100 - The ProFill 100 Capsule Filling Machine utilizes an advanced design for fool-proof manual
filling of two-piece capsules. With the ProFill 100 machine, there is no need for expensive capsule filling
equipment and electrical/vacuum connection.

Capsule Filling Machine:-

Fig. 17 Semi-Automatic Capsule Filling Machine

Finishing:-

The filled the sealed capsules necessitate finishing operation before inspection, bowling or packing in strips
and labeling. The following steps are involve in the finishing process-

Pan polishing.
Cloth dusting.
Brushing.
Sealing.
Inspection (ROTOSORT).

20
 Product List Capsules and Powder

Table 4

S.N. Capsules & Powder

1 Amoxycilline Trihydrate capsules IP 250 mg

2 Amoxycilline Trihydrate capsules IP 500 mg

3 Ampicilline Capsules IP 250 mg

4 Ampicilline Capsules IP 500 mg

5 Cephalexin Capsules IP 250 mg

6 Cephalexin Capsules IP 500 mg

7 Doxycycline Hydrochloride capsules IP 100 mg

8 Tetracycline capsules IP 250 mg

9 Tetracycline capsules IP 500 mg

10 Oral Réhydrations Salt citrate 270gm IP

21
 Oral Liquids:
Oral liquids are the homogeneous liquid preparations, usually contains a solution, an emulsion or a suspension or
one or more active ingredients in a suitable liquid base. They are prepared for oral administration rather as such or
after dilution. They may contain other substances such as suitable dispersing. solubilizing, wetting, emulsifying,
stabilizing, and antimicrobial substances for preservation.

They may also contain suitable sweetening agents, flavoring agents and permitted colored agents. If sodium
saccharin or potassium saccharin is used for sweetening. then its concentration in pediatric preparations should not
be more than 5 mg per kg of body weight

Types of Oral Liquids:

1. Syrup

2. Oral Suspension

3. Oral Solution

4. Oral Drops

5. Oral Emulsion 6. Mixture

7. Linctus

8. Elixir

Advantages of Oral Liquids:

1. Immediate available for absorption.

2. Easy administration

3. Bitter drugs can be given by this route

Disadvantages of Oral Liquids:

1. Less stable compare to solid dosage forms.

2. They are bulky and difficult for store and transport.

3. Incompatibility is more.

Methods of Preparing Syrups

Hot Process. This method is used when active constituents are neither volatile nor heat-labile.
Percolation. Sucrose is placed in percolator. ...
Agitation Without Heat. Procedure for heat-labile constituents. ...
Addition of Medicating or Flavouring Liquid to Syrup
22
 Step for manufacturing of oral.
1. Planning of Material Requirement 2. Liquid Preparation

3. Filling

4. Labeling

5. Packaging

6. Sales of Drug Products

The above mentioned steps are usually involved in the manufacturing of the oral liquids formulations in stepwise
manner. Each step has its unique role in the process of manufacturing of the pharmaceutical oral liquid dosage
form.

The most important step in the manufacturing is the planning of material requirement it usually done by the quality
peoples. By the proper planning one can set the benchmark for the manufacturing. Liquid preparation is another
step which is play important role. Here the 75% of work is done of the manufacturing of oral liquid. Then filling
and labeling are also done with the help of

labor assign to the same purpose. After labeling packing is done to ensures the products used for the mankind.
Lastly the most important phase of the oral liquid manufacturing is get performed called sales of the drug products

Automatic Sugar Syrup Manufacturing Process

Step:1 Sugar Grading & sieving Process (Machine – Vibro Sifter)

Step:2 Sugar Transfer in the sugar melting vessel (Machine – Vacuum Transfer System)

Step:3 Sugar Melting Process by Sugar and D.M.water mixed and heated in sugar melting
vessel so sugar is malted (Machine –Sugar Melting Vessel)

Step:4 Melted Sugar to be filtered for removing impurity of solid particles and transfer the
manufacturing vessel (M/c. Basket Filter and Transfer Pump)

Step:5 Syrup manufacturing by adding drugs & ingredient in malted sugar and mixed by
stirrer and high speed homogenizer with heating. Also the material re circulated in the
vessel after that readiness of syrup it will be cooled by cooling system.(Machine –Syrup
Manufacturing Vessel)

Step:6 Cooled syrup will be transfer through inline homogenizer and filter press for
homogenize mixing and filtered up to 5 microns size in storage tank.
(M/c Inline Homogenizer & Filter Press)

Step:7 The syrup is storage in the storage vessel and when transfer to the filling machine
that time mixed by stirrer. (Machine –Storage Tank)

23
 Step:8 Syrup transfer to float tank of filling machine by transfer Pump system
(Machine – Tranfer Pump)

Liquid syrup will be packed in bottle by filling & sealing & packing line
machinery.
Step: 9 Automatic washing of all vessel and Tank by CIP system

List of the equipments used in the manufacturing:

1. Mixing and storage tank

2. Portable mixer

3. Colloid mill

4. Filter press 5. Semi automatic bottle filling machine

6. Water still

7. Labeling Machine

Formulation of Oral Liquids:

1. Drug and range of excipients includes a) The vehicle: purified water and oil

2. Co-solvents Propylene glycol and glycerine

3. Sarfactants: To enhance the surface activity

4. Preservatives Used against microbial contamination

5. Sweetening agents: Glucose, saccharin, aspartame

6. Buffering agents: To regulate the pH of formulation

7. Antioxidants: BHA and BHT

24
 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.

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 Quality Control work (Summary)
Sampling of active pharmaceutical ingredients, Excipients, finished product & packing material etc.

1. Testing of API (Active Pharmaceutical Ingredients).

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

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.

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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.

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:-

VALIDATED SAMPLING SYSTEM

VALIDATED ANALYTICAL INSTRUMENT

ANALYTICAL VALIDATED METHOD

VALIDATED ANALYSIS

SUCCESSFUL ANALYSIS

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S.NO NAME MAKE / MANUFACTURER

1 Tablet disintegration machine Campbell electronics

2 Water bath six hole thermostatic control JSGW

3 pH meter ECIL

4 Magnetic stirrer Reml

5 Friability test apparatus I. Equipment Cors

6 Vacuum pump Tempo

7 Oven SEW

8 B.O.D. JRSC

9 HPLC WATERS (INDIA)

10 Six stage dissolution rate test apparatus Tab machines

11 Melting point apparatus IEC& JSGW

12 Laminar flow Klenzald

13 Flame photometer Systronic

14 Digital balance ATCO

15 Spectrophotometer UV-1601(with CVT) Shaimadzu

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PACKEGING SECTION

Packaging is the science, art and technology of enclosing or protecting products for distrib-

ution, storage,sale, and use. Packaging also refers to the process of design, evaluation,

and production of packages.Package labeling or labeling is any written, electronic, or gra-

phic 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 dies.
Forming heater.
Sealing heater.
Cutter.
Printing registration controller.

Fig. 18 Blister Packaging

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b) Strip packaging:-

The strip package is form by feeding to webs of a heat sealable flexible film through either a heated
crimping roller or a heated reciprocating platen. In this the product is drop into the pocket formed prior to
forming the final set of seals.

Machine:-

• It consist of –
Hopper.
Disc.
Channel (chute).
Two rollers (for Al foil).
Cutter (center cutter).
Conveyer belt.
Thermostat.
Selector.
• When primary (strip & blister) packaging is done. The strips & blisters are subject for secondary
packaging.

Fig. 19 Strip Packaging

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.
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The purposes of packaging and package labels
Packaging and package labeling 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 requires 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-liter-bottles of milk, rather
than having people bring their own bottles to fill themselves.

Packaging machines
A choice of packaging machinery includes, technical capabilities, labor 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.

Fig. 20 PACKAGING

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 High speed conveyor with bar code scanner for sorting transport packages.

Fig. 21
Label printer applicator applying a label to adjacent panels of a corrugated box.
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: labeling, marking, etc.
• Wrapping Machines.

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 CONCLUSION
 We made a limited helped us to imbibe the detailed information about tablet section, liquid section,
Capsule section & packaging section.

 This industrial training provided a valuable learning experience in the carrier exploration process
and gave us unexpected benefit. Now I have evaluated the class room taught facts and ideas and
applied them to thereal life situation. We came to know about many things such as the GMP
(Good Manufacturing Process),
 The Current Good Manufacturing Process (CGMP).the 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

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