B.Pharm Training report by Uttam Borah

INDUSTRIAL TRAINNING REPORT (ASSAM CHEMICAL & PHARMACEUTICAL PVT. LTD.)

Date of Submission- 4/30/2016

Name-UTTAM BORAH

Roll No- 1405511005

Reg. No- 097805514

6th Semester, Bachelor of pharmacy

INDUSTRIAL

TRAINING REPORT

Name of the Company- Assam Chemical &

Pharmaceutical Pvt. Ltd.

Submitted in partial fulfillment of the requirement for the Degree of

Bachelor of pharmacy of Assam Science and Technology University.


GIRIJANANDA CHOWDHURY INSTITUTE

OF PHARMACEUTICAL SCIENCE (GIPS) (A Unit of Shrimanta Shankar Academy)

N.H. 37, Hatkhowapara, Azara, Guwahati-17

Reg. No.- 097805514 of 2014-

15 Session

CERTIFIED to be bonafiede record of the work in INDUTRIAL TRAINNING

By UTTAM BORAH (Roll No-1405511005) of

B.Pharm. 6th Semester during the academic Session

2016(January-June) at Girijanada Chowdhury Institute of Pharmaceutical

Science (GIPS)

PRINCIPAL TEACHER-IN-CHARGE

Submitted to the Assam Science and Technology University for End Term Examination held in

June/December at Girijanada Chowdhury Institute of Pharmaceutical Science, N.H. 37, Hatkhowapara,

Azara, Guwahati-17

Date:

External Examiner Internal Examiner


CONTENTS

Sl No Subjects Page No

1. Certificate from Assam Chemical & Pharmaceutical

Pvt. Ltd. 3

2. Acknowledgement 4

3. Preface 5

4. A little word about Assam Chemical & Pharmaceutical

Pvt. Ltd. 6

5. Introduction of the industry & its products

6. Demonstration of Supply Chain Management System

7. Demineralized Water Plant

8. Demonstration of Production Area (Liquid Section)

9. Preparation & Filling of ‘AMBUSH-S’

10. Preparation & Filling of ‘PENCOLIN’

11. Demonstration of Production Area (Solid Section)

12. Preparation & Filling of ‘ACIZYME-P’ and Sealing

of ‘SEAFAX’ capsule

13. Demonstration of Production Area (Semi –Solid Section)

14. Demonstration of Quality Control Department

15. Preparation & Filling of ‘ACICOD’ & “TONSILINA”

16. Preparation & Filling of ‘HEPATONE’

17. Attendance Sheet

18. Daily activity report

19. Conclusion


ACKNOWLEDGEMENT

I consider it a great privilege & honor to have had the opportunity to undergo the industrial

training work in Assam Chemical & Pharmaceutical Pvt. Ltd. Hence, I would like to offer my

heartiest thanks to Mr. Bimal Sarma sir, Managing Director of Assam Chemical &

Pharmaceutical Pvt. Ltd.

I am greatly indebted to Prof. (Dr.) Suvakanta Dash sir; Principal GIPS, Dr Biswajit Dash

sir, Training and Placement office cum Associate Professor, Dept. of Pharmaceutics, Girijanada

Chowdhury Institute of Pharmaceutical Science, Guwahati for enabling us to have the chance of industrial

training and arranging such a nice arrangement.

I convey my heartiest thanks to Mr. R N Rajbanshi sir; Factory Manager, Mr. S Sadhu sir; Quality

Control Manager, Chemists & the workers for their most valuable suggestions, constant encouragement,

and affectionate guidance during the training period.

At last, I am greatly thankful to all my seniors and colleagues in Assam Chemical &

Pharmaceutical Pvt. Ltd. For extending their constant cooperation which went a long way towards the

completion of this Training and Report.

Uttam Borah

6th semester, Bachelor of pharmacy

Girijanada Chowdhury Institute of

Pharmaceutical Science, Guwahati-17


PREFACE

Pharmacy is a profession which is concerned with the art and science of 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 PHARMCY

each student has to undergo practical training in various pharmaceutical industries in India. I was directed

to do training at “Assam Chemical & Pharmaceutical Pvt. Ltd., A.K. Azad Road, Guwahati-16” and this

report contains a brief description of above pharmaceutical industry which was observed during the

practical training program.

Uttam Borah

6th semester, Bachelor of pharmacy

Girijanada Chowdhury Institute of

Pharmaceutical Science, Guwahati-17


A FEW WORD ABOUT THE INDUSTRY

Assam Chemical and Pharmaceutical Pvt. Ltd. is one of the oldest pharma industry

of India. It is a Private Company incorporated before independence on 13 March 1946

with a keen desire and aspiration to serve humanity through the finest quality medicaments.

This pioneer leadership in healthcare of North East is situated in front of “B. Boruah

Cancer Hospital”, Birubari, A.K. Azad Road, Guwahati-16. Assam Chemical and

Pharmaceutical Pvt. Ltd is a name of trust, excellence and quality in the pharmaceutical

industry of North East. They strive to serve the humanity in the best possible way by

providing them a wide range of innovative and quality medicines. At Assam Chemical and

Pharmaceutical Pvt. Ltd cGMP (current good manufacturing practice) are strictly

followed at all levels of manufacturing process. This industry has all the essential Sections

of Medicine. They have a layout according to the international standard. It is centrally air

conditioned and have latest machinery.

This company presently dealing with more than twenty formulation including

Capsules, Dry syrups, Syrup, Suspensions, Emulsions, Solutions, Linctus, Ointment, lotion and

many more.

The Managing Authority of Assam Chemical and Pharmaceutical Pvt. Ltd. consist of-

1. Managing Director- Mr. Bimal Sarma

2. Factory in-charge- Mr. R.N. Rajbanshi

3. Chemist- Mr. P. Boruah, Mr. U. Saikia and Mr. Arup Barman

4. Quality Control Department- Mr. S. Sadhu and Miss Tamasha Sarma

5. Public Relation Officer- Mr. Anup Deka

6. Sales Executive- Mr. Madhab Das

Day-1 April 8, 2016


FIRST DAY ACTIVITY

At the Day-1 Factory manager introduced us to the various departments and

marketed products of Assam Chemical and Pharmaceutical Pvt. Ltd. The Various

departments are mentioned bellow-

Production area

Quality assurance department

Supply chain management department.

Technical service department.

He also demonstrated us about their products. The various products manufactured

by Assam Chemical and Pharmaceutical Pvt. Ltd are-

Sl No. Brand Name Composition Uses

LIQUID DOSAGE FORM

1

Vinex-P Syrup

(100ml)

Each 5ml contains--------

Vitamin-A 500IU

Vitamin B1 0.74mg

Vitamin B2 0.75mg

Niacinamide 7.50mg

D-Panthenol 1.25mg

Vitamin B6 0.5mg

Vitamin B12 0.5mg

Vitamin D3 100IU

Zinc Sulphate 22.20mg

Health

Tonic

(Pediatric

use only)

2

Vinex Syrup

(200ml)

Each 5ml contains--------

Vitamin B1 1.8mg

Vitamin B2 1mg

Vitamin B6 0.5mg

Vitamin B12 0.5mg

Niacinamide 20mg

Protein Hydrolase 300mg

L-Lysine Monohydrochloride 20mg

Iron Choline Citrate 20mg

Alcohol 5%v/v

Calcium Lactate 10mg

Health

Tonic

(Adult

Use only)

Day-1 April 8, 2016


Sl

No.

Brand Name Composition Uses

3

Acicod

(400ml)

Each 5ml contains-----

Vitamin A 1000IU

Vitamin D 100IU

Vitamin B1 1mg

Vitamin B2 1mcg

Niacinamide 8mg

Calcium Hypophophite 40mg

Potassium Guaiacol Sulphonate

250mg

Cresol 2mg

Alcohol 2%v/v

Colour-Caramel

Lung Tonic

4

Varmitone

Suspension

(10ml)


Albendazole 200mg

Alcohol 1%v/v

Antihelminics

5

Pencolin

Linctus

(50ml)


Potassium Guaiacol Sulphonate 7.5mg

Aluminium Chloride 50mg

Chlorpheniramine Maleate 2.5mg

Vasaka 100mg

Manthol 0.25mg

Camphor 0.5mg

Alcohol 5%v/v

Antitussive

Soothing

Anti-allergic

Anti-spasmodic

Decongestant

6

Gasmag Gel

(200ml)


Activated Dimethicone 50mg

Magnesium Hydroxide 250mg

Dried Aluminum Hydroxide 250mg

Antacid Gel

7

Hepatone

(200ml)


Tricholine Citrate 0.55gm

Sorbitol Solution (70%) 7.15gm

Alcohol 0.5%v/v

Liver Tonic

8

Acicitron

(100ml)


Disodium Hydrogen Citrate 7.5mg

Alcohol 2%v/v

Systemic alkaliser

9

Tonsilina

(15ml)


Resorcinol 4%w/v

Carbolic Acid 1%w/v

Menthol 0.5%w/v

Camphor 0.5%w/v

Acne

Seborrheic dermatitis

Eczema

Psoriasis

10

Acifate

(200ml)


Sucralfate USP 1.0gm

Ulcer Healing Agent

Day-1 April 8, 2016


Sl

No.


11

Ringsol

(12ml)


Acetic Acid 2%w/v

Salicylic Acid 5%w/v

Carbolic Acid 2%w/v

Benzyl Benzoate 2.5%w/v

Early remission

induction

Lesions regression

Psoriasis

12

Acizyme

(200ml)


Alpha amylase 100mg

Cinnamon oil 0.4mg

Caraway oil 0.4mg

Cardamom oil 0.4mg

Alcohol 1%v/v

Carminative

(Adult Use only)

13

Acizyme – P

(50ml)


Fungal Diastase 20mg

Cinnamon oil 400mcg

Caraway oil 400mcg

Cardamom oil 400mcg

Carminative

(Pediatric use only)

14

Ambush Plus

(100ml)


Ambroxol Hydrochloride 15mg

Guaiphenesin 50mg

Terbutaline Sulphate 105mg

Chlorpheniramine Maleate 2mg

Menthol 1mg

Alcohol 1%v/v

Expectorant and anti-

allergic

15

Ambush-S

(100ml)


Ambroxol Hydrochloride 15mg

Salbutamol Sulfate 1mg

Alcohol 1%v/v

Expectorant (Non-

Allergic)

16 Axime Dry Syrup Cefixime trihydrate Antibiotics

17 Seafax Dry Syrup Cephalaxine trihydrate Antibiotics

18 Amox Dry Syrup Amoxycillin trihydrate Antibiotics

SOLID DOSAGE FORM

Sl

No.


1 Axime Capsule Cefixime trihydrate 100/200mg Antibiotics

2 Seafax Capsule Cephalaxine trihydrate 250/500mg Antibiotics

3 Amox Capsule Amoxycillin trihydrate 250/500mg Antibiotics

SEMI-SOLID DOSAGE FORM

1

Aspoline

Subarnavarna 0.2%, Garden Marigold 0.2%,

Yasada Bhasma 3%, Tankana Bhasma 1%,

Aloe Vera Oil Extract 1%, Surasar 1% v/w

Antiseptics and

other minor skin

disease

Day-1 April 8, 2016


Then Managing Director of Assam Chemical and Pharmaceutical Pvt. Ltd.

Respected Mr. Bimal Sarma sir told us about the rules and regulation of Assam Chemical

and Pharmaceutical Pvt. Ltd. These are-

1. The timing of the company is 10.00am to 5.00pm. The lunch break is 1.00pm to

2.00pm. So we were told to maintain the time accordingly.

2. Each trainee must come every working day.

3. No camera or photography not allowed inside the company premises.

4. As the company premise is tobacco free zone so tobacco products are not allowed.

5. He also advised us to maintain proper discipline inside the company premises.

Signature………………………….

(Managing Director/ Factory in-charge)

Day-2 April 9, 2016


SUPPLY CHAIN MANAGEMENT DEPARTMENT

At the Day-2 Factory manager demonstrated us about Supply chain management

of Assam Chemical and Pharmaceutical Pvt. Ltd.

Day-2 April 9, 2016


In short functions are:

1. Purchase materials according to requirement.

2. Maintain proper inventory of both raw materials and finished goods.

3. Maintain inventory of tool manufacturer.

WAREHOUSING

According to him Ware house is a store room to store raw materials, packaging

materials and finished goods.

The main functions of ware house are given below:

Receiving in-voice and purchase order from material management.

Receiving materials.

Cleaning of received materials.

Weighing of received materials and compare with purchase order.

Dispensing of materials according to DOS for production.

Receiving of finished goods from production.

Inventory of tool manufacture also maintain by ware house.

Documentation.

Arrangement of ware house:

According to materials:

Finished goods Packaging materials Raw materials

For export. For export products. Same raw materials

used for the product

of both export and local market.

For local market. For local marker.

According to Q.C. release:

I. Q.C. released materials (green marked).

II. Quarantine materials (not yet released by Q.C. department ,yellow

marked).

Day-2 April 9, 2016


PREMISES:

It is was well situated, well laid out, tidy, clean and well secured enabling

good preservation of raw material, packaging material and finished

products.

Temperature was maintained between 15-30 °C.

Humidity was set between 35-60%.

Checking physical stocks regularly.

Preparing Daily & Weekly Stocks Reports.

In Assam Chemical and Pharmaceutical Pvt. Ltd. ware house was separated into:

Raw material store.

Packing material store.

Finish good store.

RAW MATERIAL STORE:

Here we have seen many active ingredients along with pharmaceutical excipients.

Some of them are enumerated bellow-

Active Ingredients- Vitamin A, B1, B2, B6, B12, D3, Zinc Sulphate, Cresol,

Potassium Guaiacol Sulphonate, Niacinamide, Albendazole, Alcohol, Aluminium

chloride, Chlorphenaramine maleate, Vasaka, Menthol, Camphor, Dimethicone,

Magnesium hydroxide, Aluminium hydroxide, Cinnamon oil, Caraway oil,

Cardamom oil, Sucralfate, Disodium Hydrogen Citrate, Resorcinol, Carbolic Acid,

Camphor, Ambroxol, Terbutaline, Salbulamol, Tricholine, Iron choline citrate,

Acetic Acid, Salicylic Acid, Carbolic Acid, Benzyl Benzoate, Amoxycillin etc.

Pharmaceutical Excipients- Glycerine, Invert Sugar, Ethyl Acetate, Sodium

propyl parabean, Propylene glycol, sorbitol solution, Tartazine, Caramel,

Erythrosine, Gums, Sunset Yellow, Brilliant Blue, Quinoline Yellow, Strawberry

flavour, vanilla flavour, pineapple flavour, Phenol, sodium metabisulphite,

aloevera gel, disulfiram, olium lini, absolute alcohol,grape seed extract,isopropyl

alcohol,maize starch,propyl paraben,magnesium stearate,etc.

Day-2 April 9, 2016


PACKAGING MATERIAL STORE: Containers, Closers, Labels, Gums,

Dropper, Cap, Dispenser, Leaflets, Cartrons, Collapsible Tubes, Aluminum Foil,

Blister Pack, Alu alu pack, Corrugated Box, Product label, Transparent self-

adhesive tap etc.

FINISHED GOOD STORE: Here all the finished products are stored. We have

seen Pencolin, Ambrox Plus, Ambrox-S, Amox Capsule, Acizyme-P, Vinex and

many more marketed products there.

ISSUANCE OF RAW MATERIAL:

The weighing of raw materials is carried out in the presence of pharmacist.

Production Pharmacist checks all the Raw Material by weight/volume on the weighing

balance according to manufacturing order. After weighing, the raw material is transferred

in the relevant section of production department. The copy of the manufacturing order is

kept by the Assistant Store Manager for record and another copy is given to production

pharmacist.

DOCUMENTATION:

Following documentations were done in ware house at different stages:

Temperature/humidity chart.

Dispensing log book.

Raw material requisition.

Raw material analysis report.

Request for retest.

Certificate of analysis.

Issuance of slips (Pink slip: material identification, Yellow slip:

sampled at QC, Green slip: passed from QC).

Signature…………………………………..

(Factory in- charge)

Day-3 April 12, 2016


DEMINERALISED WATER PLANT

At Day-3 we were demonstrated about Demineralized water i.e. distilled water. According

to WHO-GMP guidelines Deionized water can only be used as vehicle in various

pharmaceutical formulation and cleaning of containers, closures or any other purpose

where water required. Demineralization is the process of removing mineral salts from water

by using the ion exchange process. Demineralized water is water completely free (or

almost) of dissolved minerals as a result of one of the following processes -

Distillation

Deionization

Membrane filtration (reverse osmosis or nanofiltration)

Electrodyalisis

Or other technologies.

Demineralized water also known as Deionized water, water that has had its mineral

ions removed. Mineral ions such as cations of sodium, calcium, iron, copper, etc. and

anions such as chloride, sulphate, nitrate, etc. are common ions present in water.

Deionization is a physical process which uses specially-manufactured ion exchange resins

which provides ion exchange site for the replacement of the mineral salts in water with

water forming H+ and OH- ions. Because the majority of water impurities are dissolved

salts, deionization produces a high purity water that is generally similar to distilled water,

and this process is quick and without scale buildup.

Principle :

Raw water is passed via two small polystyrene bead filled (ion exchange resins)

beds. While the cations get exchanged with hydrogen ions in first bed, the anions are

exchanged with hydroxyl ions, in the second one.

Process :

In the context of water purification, ion-exchange is a rapid and reversible process

in which impurity ions present in the water are replaced by ions released by an ion-

exchange resin. The impurity ions are taken up by the resin, which must be periodically

regenerated to restore it to the original ionic form. (An ion is an atom or group of atoms

with an electric charge. Positively-charged ions are called cations and are usually metals;

negatively-charged ions are called anions and are usually non-metals).



The following ions are widely found in raw waters :

Cations Anions

Calcium (Ca2+) Chloride ( Cl-)

Magnesium (Mg2+) Bicarbonate (HCO3-)

Sodium (Na+) Nitrate (NO3-)

Potassium (K+) Carbonate (CO32-)

Ion Exchange Resins:

There are two basic types of resin - cation-exchange and anion-exchange resins.

Cation exchange resins will release Hydrogen (H+) ions or other positively charged ions

in exchange for impurity cations present in the water. Anion exchange resins will release

hydroxyl (OH-) ions or other negatively charged ions in exchange for impurity anions

present in the water.

The application of ion-exchange to water treatment and purification. There are

three ways in which ion-exchange technology can be used in water treatment and

purification

1. Cation-exchange resins alone can be employed to soften water by base

exchange;

2. Anion-exchange resins alone can be used for organic scavenging or nitrate

removal;

3. Combinations of cation-exchange and anion-exchange resins can be used to

remove virtually all the ionic impurities present in the feed water, a process

known as deionization. Water deionizers purification process results in water of

exceptionally high quality.



Stored In Stainless stell Vessel

UV Treatment

DM Water

Mixed Bed

Anion Exchange Resin

Cation Exchange Resin

Tape WaterAt Assam Chemical & Pharmaceutical

Pvt. Ltd. we have seen two DM water

Plant one of whom has 2000L capacity

And another one 800L. These DM

Water is treated under Ultra Violet Ray

Of 350nm which can efficiently killed

The pathogens or viable organism.

This Demineralized water is used to

Prepare various dosage forms.

Fig- Flow Chart of Demineralized Water

Plant at Assam Chemical & Pharmaceutical

Pvt. Ltd

Signature…………………………………

(Factory in-charge)



DEMONSTRATION OF PRODUCTION AREA(LIQUID-SECTION)

We were demonstrated about the production area (Liquid Section), its layout and

different equipment’s used to prepare a pharmaceutical formulation.

Role of production department:

Whole pharmaceutical stands on this department.

Manufacturing of different pharmaceutical products are controlled by this

department.

This department produce tablets capsules oral liquid preparation in industry and

other pharmaceutical dosages.

Role of production department in industry is to make quality medicine

Procedure of manufacturing in production area:

In production area following sequences is followed for proper manufacturing of

medicine

Generation of M.O (manufacturing order) under instruction of business

development department that pass buyers order of medicine to production

department.

M.O is checked by Q.C department API(Active Pharmaceutical Ingredients)

quantity is checked and signed by Q.C if quantity is within reign otherwise it will

be rejected.

M.O is sent to raw material store and dispensed according to cGMP.

Dispensed material is shifted into production area for further processing and

manufacturing of medicines.

Oral liquid preparation procedure is different capsules. All these will be discussed

later

Personnel in Production department:

These are following personnel in production department.

Factory manager

Chemist

Packing pharmacist

Workers



Fig-Layout of the liquid section of production area

The various area of the liquid section of production area is as follows-

Preparation Area

Bottle Washing Area

Empty Bottle Checking Area

Bottle Filling Area

Capping Area

Filled Bottle Checking Area

Labelling Area

Label Checking Area

Packaging Area

Assam Chemical & Pharmaceutical Pvt. Ltd.

formulated many liquid dosage form such as -

Solution – RINGSOL, HEPATONE & TONSILINA etc.

Suspension- GASMAG GEL, ACIFATE & VARMITONE etc.

Emulsion- VINEX, VINEX-P, ACIZYME, ACIZYME-P etc.

Syrup- AMBUSH-S, AMBUSH-PLUS, ACICITRON, & ACICOD etc.

Linctus- PENCOLIN

Packaging Area

Label Checking Area

Labelling Area

Filled Bottle Checking Area

Capping Area

Bottle Filling Area

Empty Bottle Checking Area

Bottle Washing Area

Preparation Area



EQUIPMENTS AVAILABLE AT LIQUID SECTION

At Assam Chemical & Pharmaceutical Pvt. Ltd. there are lots of equipment’s available for

formulating liquid dosage form. Their name and uses are enlisted below-

SL NO

NAME OF THE EQUIPMENTS

DESCRIPTION/USES

1

Emulsifier

1. To make emulsion.

2. As stir for mixing different ingredients.

2

Pressure filter

Use for filtration purposes during

manufacturing or finished product.

3

Formulation Vat/ Charge Vat

Here product is formulated by adding

ingredients in pharmaceutical order.

4

Storage Vat

Finish product which is waiting for filling is

stored.

5

Bottle Washing Assembly

Bottles are washed here by distilled water and

then send for filling of product.

6

Empty Bottle Checking Assembly

Before filling empty bottles are checked using

light for any dirt/insect inside the bottles.

7

Volumetric Filling Machine with 6

nozzles (50-400ml Capacity)

Used to insert product in the bottles. It can fill

six bottles at a time.

8

Cap Sealing Machine

This machine seal the cap at bottles.

9

Fill Product Checking Assembly

Filled bottle were checked here whether they

are fill properly or not.

10

Labelling Assembly

Labels are attached at the bottle by this

machine and then send for packaging.

11

Belt Conveyers

They carry materials from one place to another

systematically & automatically.

Signature…………………………………..




PREPARATION & FILLING OF AMBUSH-S (2000L)

At this day we prepared an expectorant named as AMBUSH-S and also did the filling,

labelling & packing at the bottle.

Batch Size- 2000L

File Size- 100ml

Equipment’s Used- Electric Stir, Stainless still pot, Charging Vat, Pressure filter, bottle

washing unit, volumetric filling machine, cap sealing machine, labelling & packaging unit

etc.

Active Ingredients- Salbutamol & Ambroxol.

Pharmaceutical Aid- Sorbitol, Sodium Benzoate, Sodium Saccharin, Glycerin, Alcohol,

Raspberry, Citric acid, Brilliant blue and Quinoline yellow.

Procedure:

1. First we calculated out how much quantity of each ingredient required and weighed

them and keep separately.

2. Sorbitol and Glycerin was transfer to main vat.

3. Sodium Benzoate Sodium Saccharin were dissolved in demineralized water and

was added to main vat.

4. Salbutamol Sulphate was dissolved in demineralized water and was added to main

vat. Then check the ph of the mixture and adjust the pH in between 4.5-5.2 using

citric acid.

5. Propylene glycol and ambroxol hydrochloride was mixed with the aid a stir and

transfer to main vat and being mixed thoroughly. Raspberry (Flavoring agent),

Brilliant blue and Quinoline yellow as color and alcohol was added to the above

preparation. Again adjust the pH between 4.5-5.2 and was filtered.

6. Then it’s quality was checked by quality control department. If QC department

permitted then only it was filled in container, labelled & packed and stored in

warehouse.

Signature…………………………………..




PREPARATION & FILLING OF PENCOLIN (2000L)

At this day we prepared an antitussive named as Pencolin and also did the filling,


Batch Size- 2000L

File Size- 50ml



etc.

Active Ingredients- Potassium Guaicol, ammonium Chloride, Chlorpheniramine, Vasaka,

Menthol.

Pharmaceutical Aid- Invert sugar, Sorbitol, Sodium Benzoate, Sodium methyl paraben,

Glycerin, Alcohol, Propyl paraben, Citric acid & Raspberry.

Procedure:



2. Invert sugar, Sorbitol and Glycerin was transfer to main vat.

3. Sodium Benzoate, Sodium methyl paraben were dissolved in distilled water and


4. Potassium Guaicol was dissolved in boiled water & ammonium Chloride was added

in demineralized water and was transferred to charge vat. Similarly,

Chlorpheniramine was also added.

5. Vasaka was dissolved in hot demineralized water and was filtered and transferred

to main vat.

6. Alcohol, Propyl paraben, menthol & Raspberry (Flavoring agent) was mixed with

the aid a stir and transfer to main vat and being mixed thoroughly. Coloring agent

was added to the above preparation. Adjust the pH between 4.8-5.2 and was filtered.



warehouse.

Signature…………………………………..




Finished Capsule

Cleaning of Capsules

Capsule Closing

Powder Filling

Orientation and Separation of Capsule

Mixing of Active Ingredients & Exipients

Approved Raw Material

DEMONSTRATION OF PRODUCTION AREA (SOLID SECTION)

We were demonstrated about the solid section of production area, its layout and different

equipment’s used to prepare a pharmaceutical formulation.

CAPSULE PREPARATION UNIT

STEPS INVOLVED IN CAPSULE MANUFACTURING:

DISPENSING OF RAW MATERIAL:

Capsulation process starts with dispensing of active

ingredients. Weigh and dispense system begins with

a pharmacist getting a bill of materials for ingredients

that make up a recipe for a batch to be manufactured.

Each material must be gathered from a warehouse.

Then it is verified as the proper material, carefully

weighed, checked again, and finally readed for

mixing in the recipe.

MIXING & FILLING:

The active ingredients along with excipients were

mixed in a double cone blender. The mixture is filled

in empty capsule. Assam Chemical & Pharmaceutical

Pvt. Ltd, presents an exclusive array of capsule filling

machinery. This capsule section machinery is semi-

automatic or manual and it is simple to operate.

CAPSULE POLISHING:

After capsule filling capsules were polishes manually

by hand using cloth.

LABELING & PACKING:

Capsules are packaged into strip & blister packaging

and then finally in big boxes.



Equipment’s Available in Capsule Section:

At Assam Chemical & Pharmaceutical Pvt. Ltd. there are lots of equipment’s

available for formulating liquid dosage form. Their name and uses are enlisted below-

SL NO


DESCRIPTION & USES

1

Semi-Automatic Capsule Filling

Machine

Used to fill power mixture inside the body of the

capsule and to place & Seal the capsule cap.

Used when large amount of capsule is

manufactured. It is semi-automated process.

2

Manual Capsule Filling Machine

Used to fill power mixture inside the body of the

capsule and to place & Seal the capsule cap.

Used when small amount of capsule is

manufactured. Operated by hand.

3

Cone (Double) Blender Used to mixed excipients with active

pharmaceutical ingredients.

4

Blister Packaging Machine

Used to pack the capsules inside the blister and

to labelled them. It is a semi-automated process.

5

Air flow & Handling Unit

It provide fresh air inside the production area

6

Dispensing Balance

Used to take weight of different ingredients.

7

Humidity Control Assembly

Provide uniform humidity inside capsule filling

and blister packaging section.

8

Tray Dryer

Used to dry the granules or powders.



Weighing of Ingredients

Proper mixing in blender

Homogenous mass is filled

in bottles

Labelling & Packaging

DRY SYRUP UNIT

Dry Syrups are commercial dry mixtures that require the addition of water at the

time of dispensing. A number of official and commercial preparations are available as dry

powder mixtures or granules that are intended to be suspended in water or some other

vehicle prior to oral administration. Most of the drugs prepared as a dry suspension for oral

suspension are antibiotics. The dry mixture of oral suspension is prepared commercially to

contain the drug, colorants, flavors, sweeteners, stabilizing agents, suspending agents and

preserving agents that may be need to enhance the stability of the formulation.

Major application - pediatric therapy: Oral Route of administration is the route

of choice for administration of medicines in children. The only hurdle for dosage form

designing for pediatric patients is the patient’s acceptance of the dosage form. Pediatric

Patients tend to become un-cooperative during the administration of oral medication; the

most common reason being the taste of the oral formulation administered among the

children. Most of the drugs administered as granules for oral suspension under pediatric

therapy are Antibiotics, which when administered orally as any other dosage form have a

bitter taste making it unpleasant for Children to consume the medication.

In Assam Chemical & Pharmaceutical Pvt. Ltd. dry syrups are prepared by powder

blending method. The required active ingredients along with other additive blend in a cone

blender and a homogenous mass is prepared.

Fig- Layout of Dry Syrup Preparation area

Advantages

Least capital equipment and energy

Least likely to have chemical and stability problems because no heat or solvents

are used.

Low moisture content can be achieved in dry mixture.

Disadvantages

Prone to homogeneity problems – Particle size and Powder flow.

Loss of the active ingredient during mixing.

Potent drug used in very low concentrations.



EQUIPMENTS AVAILABLE AT LIQUID SECTION

At Assam Chemical & Pharmaceutical Pvt. Ltd. there are lots of equipment’s available for

formulating liquid dosage form. Their name and uses are enlisted below-

SL NO


DESCRIPTION/USES

1

Air flow & Handling Unit

It provide fresh air inside the production area

2

Dispensing Balance


3

Humidity Control Assembly

Provide uniform humidity inside capsule

filling and blister packaging section.

4

Tray Dryer

Used to dry the granules or powders.

5

Cone (Double) Blender

Used to mixed excipients with active

pharmaceutical ingredients.

Signature…………………………………..




PREPARATION & FILLING ‘ACIZYME-P’ and SEALING of ‘SEAFAX’

CAPSULES

At this day we prepared an antitussive named as ‘Acizyme-P’ and also did the filling,


Batch Size- 2000L

File Size- 50ml



etc.

Active Ingredients- Cinnamon oil, Caraway oil, Cardamom oil & fungal diastase

Pharmaceutical Aid- Sorbitol, Sodium Benzoate, Sodium methyl paraben, Sodium Propyl

paraben, Bromochol, Propylene glycol, Glycerin & Citric acid.

Procedure:



2. Required quantity of sorbitol base was added to main vat.

3. Sodium Benzoate, Sodium methyl paraben, Sodium Propyl paraben & Bromochol

was dissolved in demineralized water and was added to main vat.

4. Cinnamon oil, Caraway oil & Cardamom oil were mixed with glycerin and

propylene glycol and was transferred to main vat.

5. Adjust the pH of the above mixture between 5.5-6.5.

6. Fungal Diastase was dissolved in demineralized water in a stainless still pot.

7. Add to the main vat, make up the volume up to 2000L by adding demineralized

water. Again pH was adjusted using citric acid between 5.5-6.5.



warehouse.



FILLING & SEALING of ‘SEAFAX’ CAPSULES

At Assam Chemical & Pharmaceutical Pvt. Ltd. two types of capsule filling and

sealing machines are available. These are-

HAND OPERATED CAPSULE FILLING MACHINE:

It consists of a bed having 200-300 hole, a

loading tray having 200-300 holes, a powder tray, a pin

plate having 200-300 pins, a sealing plate having a

rubber top, a lever, a cam handle. The empty capsules

are filled in the loading tray and it is placed over the bed.

The cam handle is operated to separate the capsule caps

from their bodies.

The powder tray is placed in a proper position

and filled with an accurate quantity of powder with

scraper. The excess of the powder is collected on the

platform of the powder tray. The pin plate is lowered

and the filled powder is pressed by moving the pin downwards.

After pressing the pin plate is raised and the remaining powder is filled into the

bodies of the capsules. The powdered tray is removed after its complete filling. The cap

holding tray is again placed in position. The plate with the rubber top is lowered and the

lever is operated to lock the caps and bodies. The loading tray is then removed and filled

capsules are collected.

With a 200-hole machine, about 5000 capsules can be filled in one hour, whereas

in a machine having 300 holes, about 7500 capsules can be filled in one hour.

SEMI-AUTOMATIC CAPSULE FILLING MACHINE:

Operation is simple. Meet the hygiene requirements of the pharmaceutical

industry. Contact parts Stainless steel construction and use of non-corrosive approved

materials eliminates contamination and facilitates easy cleaning.

Suitable for filling powder and granular materials in pharmaceutical and health

food industries. Simple design and robust construction ensure long life and trouble free

operation.



Active Ingredients: Cephalexin I.P

Pharmaceutical Aid: Magnesium Stearate & Empty gelatin cell.

Equipment’s Used: Dispensing Balance, Cone Blender, Capsule filling Machine, Blister

Packaging Machine.

Procedure:

Take the cap sheet. Place it on a clean, dry surface.

Place the encapsulation sheet on top of the cap sheet using the black pegs to fix it

correctly in place.

Pour capsule tops into the encapsulation sheet and, using a circular motion; gently

shake the tops into the holes. While doing this, cover the gap in the wall of the

encapsulation sheet with one hand to avoid spilling the tops.

When the holes are filled pour out the excess tops.

Remove the encapsulation sheet and put the filled cap sheet to one side.

Now take the bottom sheet. Fix the encapsulation sheet to the bottom sheet, using

the black pegs to fix it correctly in place.

Pour bottoms into the encapsulation sheet and shake as before to fill the holes. Pour

off excess bottoms.

Remove the filled encapsulation sheet and put it carefully to one side.

Pour a soop of powder filler onto the bottom sheet and use the spreader to fill the

bottoms. Remove the spreader and put it to one side.

Take the filled cap sheet and place the middle sheet on top using the black pegs to

fit it correctly in place.

Turn the cap sheet / middle sheet over and fix to the bottom sheet. Using hands and

equal pressure, press down once to fit both parts of the capsule together.

Signature…………………………………..




DEMONSTRATION OF PRODUCTION AREA (SEMI-SOLID SECTION)

We were demonstrated about the semisolid section of production area, its layout

and different equipment’s used to prepare a pharmaceutical ointment, lotions etc.

Semisolid dosage forms are traditionally used for treating topical ailments. Various

categories of drugs such as antibacterial, antiseptics. Antifungals, and antivirals are

incorporated into these products, which show their activity on the surface layers of tissues

or penetrate into internal layers to reach the site of action.

Assam Chemical & Pharmaceutical Pvt. Ltd has only one ointment product. But it

is one of most widely used and top selling semi-solid preparation at North-East market;

commonly known as ‘ASPOLINE’. It is an Ayurvedic antiseptic cream.

Equipment’s available at semi solid section of Assam Chemical & Pharmaceutical

Pvt. Ltd are listed below-

SL NO


DESCRIPTION/USES

1

Planetary Mixer with stirrer &

Jacketed

Used to proper mixing of ingredients with

base.

2

Dispensing Balance


3

Storage Tank

Intermediate products or finished products are

stored.

4

Filling & Sealing and Packing Line

Machinery

Used to fill & seal ointments inside the

ointment tube.

5

Milling Assembly

Used to reduce the particle size.



Base is melted

Mixing of ingredients with base

Addition of Perfume

QC is Checked

Filling, Sealing,

Labelling & Packaging

PREPARATION OF SEMI-SOLID

Name of the Product- ‘ASPOLINE’

Base- Vaseline (Parafinum molalbum), Liquid paraffin, & Lanolin.

Active Ingredients- Zinc Oxide(Yasada vasma), Aloevera oil,Subarnabarna (Berberis

eristhata), Boric Acid(Toncana Vasma) and talcum Powder.

Fig- Layout of semi solid section

Procedure-

Step:1- Water Phase & Wax Phase & Manufacturing Phase: Fill D.M. water in than

heated and stirring after that added wax in the same container than again stirring and heated.

After complete melting and mixing of wax than to be added drugs and ingredient in same

container and mixed by stirrer. Perfume was added at last.

Step:2- The Mixed material will be passed through milling equipments for particles

size reduction and homogenize mixing than transfer to storage tank



Step:3- The material will be store in the storage tank and this tank having facility

for heating and trolley wheel for move to filling area. QC departments checked the quality

of the product.

Step:4- After the QC approval the storage tank carries to filling machine by

manually and the material will be heated by hot water circulation for easy transferring high

viscous material by metering pump to the hopper of filling machine.

Step:5- The Ointment will be fill and seal by filling machine and packed by packing

line machinery.

Signature………………………….

(Factory in-charge)

Day-10 April 23, 2016


QUALITY CONTROL DEPARTMENT:

Quality control refers to the process of striving to produce a perfect product

by a series of measures to prevent or eliminate errors in production.

The quality control department is responsible to ensure that all materials meet the

established criteria throughout all phases of the process. Raw materials, components, and

packaging and labeling are examined and tested according to a rigorous written program

designed to assure uniformity from batch to batch. Every raw material received is tested

for identity and conformance to specifications. Every bottle, cap, and label is examined to

assure that they match the written specifications. During the manufacture of all batches of

all products, in-process samples are tested and the results documented. If any results fall

outside of the written specifications, the product is rejected and the information is

submitted to the research and development group for evaluation and further disposition.

Samples of finished, packaged product are tested for stability to allow for determination of

expiration dating. Accelerated stability testing as well as real time stability testing is done

concurrently to validate the results of the tests.

QUALITY POLICY:

1. To gain customer’s satisfaction through manufacturing and providing high quality

pharmaceutical products. While believing in continual improvement of our system.

2. To achieve sustained growth in market, share by developing satisfied customers.

3. Healthy environment to develop dedicated professional teams in order to serve in

the best interest of external and internal customers. Suppliers and shareholders.

4. To benefit the community by adopting environment friendly policies and

establishing standards of ethics.

5. To improve the standard of life through the value of developing innovative products

by research and development. And to pursue Total Quality Management.

Day-10 April 23, 2016


The ISO definition states that quality control is the operational techniques and

activities that are used to fulfill requirements for quality. Quality control is a process for

maintaining standards and not for creating them. The quality control department has the

responsibility and authority to approve or reject all components, drug product containers,

closures, in-process materials, packaging material, labeling, and drug products.

Activities of QC department in Assam Chemical & Pharmaceutical Pvt. Ltd. were:

Testing and release or rejection of all incoming raw materials, packing materials,

in-process / intermediates and finished products as per specified specifications.

Maintaining testing records as per standard procedures for raw materials, packing

materials, in-process / intermediates and finished products.

Calibration of laboratory instrument / equipment.

Performing stability study.

Analytical method validation.

Preparation of standard volumetric solutions and maintain standardization record.

Maintain Labeling procedure at all the stages and records.

Maintain working / reference standard record of products.

Analysis of complaint samples as and when required.

Follow safety norms at all the stage during handling of chemicals and using

instruments.

Follow good laboratory practices.

Day-10 April 23, 2016


INSTRUMENTS IN Q.C DEPARTMENT

Different instruments are used for testing in Q.C department at Assam Chemical

& Pharmaceutical Pvt. Ltd. Their name & uses are mentioned below-

Sl No Name of the Equipment Use

1 Spectrophotometer (Single Beam) Used to measure the amount of compounds in

a sample

2 Disintegration test Appestats Used to measure disintegration time.

3 Fluorimeter Used to measure parameters of fluorescence

4 Karl Fisher Apparatus Used to measure the amount of moisture in

sample.

5 Dissolution Test Apparatus Used to determine critical in vitro drug

release information

6 Centrifuge Used to separate two components from

heterogeneous mixtures .

7 Muffle Furnace To estimated ash value or ash content

8 Melting Point Apparatus Used to determine melting point.

9 Kern & Sohn Mcg Used to measure very minute quantity like

1mcg

10 Spectrophotometer (Double beam) Used to measure the amount of compounds in

a sample

11 High Performance Liquid Chromatography (HPLC) used to separate, identify, and quantify each

component in a mixture

12 Membrane Filter Used to filter a mixture

13 Cellulose Filter Used to filter a mixture

14 pH Meter Used to detect pH of a solution.

MICROBIOLOGY SECTION

1 Zone Reader Used to check the microbial growth

2 Colony Counter used to estimate the number of viable micro

organism

3 Incubator It provide optimum growth environment for

micro-organism

4 UV Cabinet Used for various microbiological assay

5 Spreader Used to spread bacterial suspension.

6 Fumigation Chamber Used to allow fumigations to be carried out

efficiently, safely and economically

Day-10 April 23, 2016


LIBRARY AT Q.C. DEPARTMENT

A library is a collection of sources of information and similar resources, made

accessible to a defined community for reference or borrowing. It provides physical or

digital access to material, and may be a physical building or room, or a virtual space, or

both. A library's collection can include books, periodicals, newspapers, manuscripts, films,

maps, prints, documents, microform, CDs, cassettes, videotapes, DVDs, Blu-ray Discs, e-

books, audiobooks, databases, and other formats. Libraries range in size from a few shelves

of books to several million items.

There is a small library inside the quality control department at Assam Chemical &

Pharmaceutical Pvt. Ltd. It Contains-

Various edition of Indian Pharmacopeia, United State of Pharmacopeia, and

British Pharmacopeia.

Journals – 98 no’s currently

Merck's Index, Remington & books on GLP/GMP

Analytical Books etc.

Signature……………………………

(Q.C. Department)

Day-11 April 25, 2016


PREPARATION & FILLING OF ‘ACICOD’(2000L)

At this day we prepared an antitussive named as ‘ACICOD’ and also did the

filling, labelling & packing at the bottle.

Batch Size- 2000L

File Size- 400ml

Equipment’s Used- Emulsifier, Stir, Stainless still pot, Charging Vat, Pressure filter, bottle


etc.

Active Ingredients- Potassium Guaicol, Vitamin B1, B2, B12, Niacin, Vitamin A, Vitamin

D3, Calcium Hypophosphite & creosote

Pharmaceutical Aid- Propylene glycol, Glycerin, sorbitol, Citric Acid, Xantum Gum,

Thiourea, Sodium Hydroxide, Alcohol, Twen-80, EDTA, Colors & Flavors.

Procedure:


2. Base was taken in main vat. Sodium Benzoate, Xanthum gum & glycerin were

mixed properly and was added to main vat.

3. Potassium Guaicol sulphonate & Calcium Hypophosphite was dissolved in hot

demineralized water at hot vat and was added to main vat.

4. Vitamin B1 and Vitamin B2 was dissolved with the help of Sodium Hydroxide

solution and was added to main vat.

5. Vitamin A Emulsification Process

Vitamin A was heated to 400C in a water bath.

Take tween 80 and heat up to 700c

Now cool it to 400C

Vitamin A was mixed with Tween 80

Take Propylene glycol, Glycerin, sorbitol in a vat and convert it to

an emulsion with Vitamin A mixture. Total process is done within

3hour.

Day-11 April 25, 2016


6. Vitamin B12, Niacin, EDTA, Thiourea and creosote was added to main vat.

7. Flavoring agent was mixed with the aid a stir and transfer to main vat and being

mixed thoroughly. Coloring agent was added to the above preparation. Final

Volume was adjusted. Adjust the pH between 4.8-5.2 and was filtered.



warehouse.

PREPARATION & FILLING OF ‘VARMITONE’(50L)

After the lunch break we also prepared ‘VARMITONE’; an anthelmintic

suspension.

Batch Size- 50L

File Size- 10ml

Equipment’s Used- Emulsifier, Stir, Sieve 80mesh, Stainless still pot, Bottle washing unit,

volumetric filling machine, cap sealing machine, labelling & packaging unit etc.

Active Ingredients- Albendazole.

Pharmaceutical Aid- Carboxy methy cellulose, Glycerin, Sodium Methyl Paraben, Propyl

paraben, Alcohol & Citric Acid.

Procedure:

1. Carboxy methy cellulose and glycerin were mixed together.

2. Sodium Methyl Paraben and propyl paraben was dissolved in demineralized water.

3. Albendazole was sieve was using sieve of 80 mesh size & then was mixed with the

above content.

4. Essence and colors were mixed with the help of emulsifier machine.

5. Then volume was made up to 50L by adding 1% v/v & pH was adjusted using citric

acid. (4.6-5.2)

Signature……………………

Factory in-charge

Day-12 April 26, 2016


PREPARATION & FILLING OF HEPATONE

At this day we prepared an antitussive named as ‘HEPATONE” and also did the filling,


Batch Size- 2000L

File Size- 200ml



etc.

Active Ingredients- Tricholine Citratre

Pharmaceutical Aid- Sorbitol, Sodium methyl paraben, Alcohol, Sodium Benzoate, Sunset

Yellow, Citric Acid & Essence

Procedure:



2. Sorbitol and Tricholine Citrate was transfer to main vat and was mixed.

3. Sodium Benzoate, Sodium methyl paraben were dissolved in distilled water and


4. Then Essence like coloring agents and flavoring agents are dissolved in alcohol and

were added to main vat.

5. Adjust the pH between 4.5-4.9 using citric acidand was filtered.



warehouse.

Signature…………………….

(Factory in-charge)


DAILY ACTIVITY SHEET AT ASSAM CHEMICAL & PHARMACEUTICAL Pvt. Ltd.

Name of the Trainee – Uttam Borah

Roll No- 1405511005 Reg. No- 097805514

Sl No Date Activity Signature of Trainee

1 08-04-2016 Introduction of the industry & it’s products

2 09-04-2016 SUNDAY

3 10-04-2016 Demonstration of Supply Chain

Management System

4 12-04-2016 Demineralized Water Plant

5 16-04-2016 Demonstration of Production Area (Liquid

Section)

6 17-04-2016 SUNDAY

7 18-04-2016 Preparation & Filling of ‘Ambush-

s’

8 19-04-2016 Preparation & Filling of ‘Pencolin’

9 20-04-2016 Demonstration of Production Area (Solid

Section)

10 21-04-2016 Preparation & Filling of ‘Acizyme-P’ and

Sealing of ‘SEAFAX’ capsule

11 22-04-2016 Demonstration of Production Area (Semi –

Solid Section)

12 23-04-2016 Demonstration of Quality Control

Department

13 24-04-2016 SUNDAY

14 25-04-2016 Preparation & Filling of ‘Acicod’ &

“Varmitone”

15 26-04-2016 Preparation & Filling of ‘Hepatone’

Signature…………………………………

(Managing Director/Factory in-Charge)


CONCLUSION

For pharmacy students industrial training is very much essential. It is also a great

opportunity to acquire practical knowledge. During my training period in the industry I

acquired lots of experience in Pharmaceutical Production. This will help to clarify my

theory knowledge.

We had seen various instruments and apparatus in the industry. The highly

sophisticated instruments that work precisely must be operated with intense care for

optimum use. We got lots of information regarding the latest machinery and their work

procedure.

The cGMP was taught to us which are to be strictly followed in industries in each

and every section. Our company Assam Chemical & Pharmaceutical Pvt. Ltd. is also

following cGMP.

Besides above mentioned those, the training was very interesting with lots of things

to be learned. It helps us to acquire knowledge on punctuality, regularity and working

environments in industries. Hence, we can say that our goal of attending the industrial tour

is fulfilled. We acknowledge the great help of Assam Chemical & Pharmaceutical Pvt. Ltd.

******

Education

B.Pharm Training report by Uttam Borah