Production of Tablet Project

CHAPTER 1

INTRODUCTION

1.1 CORPORATE PROFILE

Plant

Swiss Medicare Pvt. Ltd. have Hi-tech state of the art plant at RIICO backed

up with his manufacturing plant complying with SCHEDULE–M at SRI

GANGANAGAR (RAJ.). SMPL is in the process of obtaining GMP

certification, ISO 9002 and World Health Organization rating. Sophisticated

gadgets ensure precision to maintain high standard and quality drugs.

Achievements

With limited resources Swiss International began to operate on Loan license

having one H.Q. Today Swiss has spread its wings in the State of Rajasthan,

Madhya Pradesh, Punjab, Haryaana, Jammu and Kashmir and UP. Swiss

International has merged in Swiss Medicare Pvt. Ltd. To broaden the area of

operation. Swiss Medicare Pvt. Ltd. attained its own plant.

Support

Skilled Filed Staff to manage and monitor the capricious market, Scenario and

abled Directors assisted by Manager (HRD) Customer Care are the prime

factors to bring laurels for this organization. Late Sh. V.M. Chadha (father)

and Late Mr. Ashvani Chadha (Elder Brother) who paved the way for SMPL

to walk steadily, confidently proudly, sincerely and honestly to reach these

height.

SMPL’s supporter’s list includes leading Doctors, Distributors and Stockiest.

Who had always been and are an integral part of success story of SMPL.

Products

Swiss International produce varied and many categories of drugs. The gambit

incorporates. Tablets Section and Liquid Section

War Cry

Leadership through Quality and Excellence.

Mission

To set new standards of Customer Care by providing, quality drugs for

requirements of mankind.

To give prompt and swift services keeping abreast of the high standards of

Business and Quality.

To make the environment trouble free.

Vision

To be market leader in the years to come with a stamp of quality and services.

To extend the area of operation globally i.e. third world countries.

Values

Customer caring leadership dedicated and enthusiastic team, full of

commitment and trusting relationship are the values, we adhere to for

continuous production of quality drugs.

Team

Honed professionals to meet all contingencies of the mission.

Production Team : Highly skilled team comprising of operators (Engineers)

Factory Manager, Production Manager and Analytical Chemist to maintain

high standards and tempo of the quality drug production.

Field Team : Managers with in-depth knowledge in Pharmaceutical field to

guide Medical Reps. Most of the managers are internally promoted and have

vast experience of field to channelise the energy of field personnel learned

MR with strong skills.

Administrative Team : Company Secretary, Manager HR and Manager

Customer Care. Swiss has the officers to assist in legal matters, to advise on

various issues related to Customer Care & Human Resources. The officer

posses in-depth knowledge of administration and secretariat and supported by

honed marketing team. They are veterans in Pharmaceutical field.

Marketing Team : Swiss has Marketing Managers and Sales Managers to

bring laurels. Directors also have vast experience of marketing and sales.

They started their career from a long rung and reached the level of supervisory

position in the same field. Directors have ample knowledge to guide the tem

and fulfill the mission with in the stipulated period of time.

1.2 MANAGING BODY

In Swiss Medicare Pvt. Ltd. there are competence and experienced personal. All

of directors have long experience in business field. Mr. Ravi Chadha is the MD of SMPL

who has also long experience pharmaceutical and business management field.

Board of Director :-

Managing Director (M.D.) : Mr. Ravi Chadha

Manager (H.R.) : Mr. Raj Lamba

Others :-

Factory Manager : Mr. Baldev Singh Kakkar

Production Manager : Mr. Arun Sharma

Production Chemist : Mr. Jagdish Rai Choudhary

Corporate Office : 5 – P Block, SGNR

Registered Office : Swiss Medicare Pvt. Ltd.

F-350 & 351 (A), Phase – II, Industrial Area,

RIICO, Sri Ganganagar-335001 (Raj.).

Ph. 0154 – 2481536(O), 2474001 (O)

1.3 PRODUCTION UNIT

Production in a pharmaceutical company consist of the creation and maintenance

of a clearly defined organization and makes effective and coordinated use of personal

land building and equipment including the management of inventory assets. All these

activities are performed in accordance with GMP standard for this purpose all production

of SMPL is divided mainly into two sections :

1. Tablet Section

2. Liquid Section

Both sections have double door entry. Both sections have air controlled

environment.

Production area was a dust free area in SMPL. This area had temperature and

humidification as per GMP specification. Wet and Dry bulb hygrometer is present in the

production area.

An automatic air cutter is fixed on the wall, on the upper side of the door (where

the entry in production area). When the door opened then air cutter started and when the

door closed then the air cutter also stop the thrown of air.

1.4 GMP FOR PREMISES AND MATERIALS

SCHEDULE M (GMP) :-

Good Manufacturing Practice (GMP) requirement of factory premises, plants and

equipment.

1.4.1 GENERAL REQUIREMENTS

a. Location and Dour rounding :-

The location of factory and its surroundings should be such as avoid risk of

contamination from external environment including sewage, drain, public lavatory or any

factory which produces disagreeable or a noxious occur, fumes dust smoke.

b. Building and Premises :

The buildings used for factory designed constructed, adapted and maintained to

suit the manufacturing operation so as to permit production of drug under hygienic

condition. They shall conform to the conditions laid down in the Factories Act, 1948 (63

of 1948).

c. Water System :

Treatment of water so as to produce purified water confirmed to I.P. specification.

Water should be stored in tank do not adversely effect quality of water stored in tank.

d. Disposal of Waste :

Provision shall be made form proper storage and disposable of material awaiting

disposable. All bio-medical waste shall be destroyed as per the provisions of the Bio-

Medial Waste (Management and Handling) Rules, 1996.

1.4.2 WAREHOUSING :

Adequate area shall be design and provide with proper rack, bins and plat form

for storage and warehousing of all material and products, machine and equipment parts

etc.

They shall be clean, dry and maintained within acceptable limit.

There shall be a separate sampling area in ware housing for active raw material

and excipient.

Printed packaging material shall be stored in safe, separate, secure area.

Separate dispensing area under differential pressure shall be provided.

1.4.3 PRODUCTION AREA :

The production area shall be design to allow production preferably in uniflow and

with logical sequence of operation. In order to avoid the risk of cross-contamination

separate dedicated and self-contained facilities shall be made available for the production

of sensitive pharmaceutical products like penicillin or biological preparations with live

microorganisms. Separate dedicated facilities shall be provided for the manufacture of

contamination causing and potent products such as Beta-Lactum, sex hormones and

cytotoxic substances.

Working and in-process space shall be adequate to permit orderly and Logical

positioning of equipment and materials and movement of personnel to avoid cross-

contamination and to minimize risk of omission or wrong application of any

manufacturing and control measures.

Pipe-work, electrical fittings, ventilation openings and similar services lines shall

be designed, fixed and constructed to avoid certain of recesses. Services lines shall

preferably be identified by colors and the nature of the supply and direction of the flow

shall be marked / indicated.

1.4.4 ANCILLARY AREA :

Rest and refresh room shall be separate from other area.

Facilities for changing, storing clothes and for washing 2 toilet purpose easily

accessible.

1.4.5 QUALITY CONTROL AREA :

Quality control laboratories shall be independent of the production areas.

Separate areas shall be provided each for physico-chemical, biological, microbiological

or radioisotope analysis. Separate instrument room with adequate area shall be provided

for sensitive and sophisticated instruments employed for analysis.

Quality Control Laboratories shall be designed appropriately for the Operations to

be carried out in them. Adequate space shall be provided to avoid mix-ups and cross

contamination. Sufficient and suitable storage space shall be provided for test samples,

retained samples, reference standards, reagents and records.

The design of the laboratory shall take into account the suitability of construction

materials and ventilation. Separate air handling units and other requirements shall be

provided for biological, microbiological and radioisotopes testing areas. The laboratory

shall be provided with regular supply of water of appropriate quality for cleaning and

testing purpose.

Quality Control Laboratory shall be divided into separate sections i.e. for

Chemical, microbiological and wherever required, biological testing. These shall have

adequate area for basis installation and for ancillary purposes. The microbiology section

shall have arrangements such as airlocks and laminar airflow workstation, wherever

considered necessary.

Facilities for changing, storing clothes and for washing 2 toilet purpose easily

accessible.

1.4.5 PERSONAL :

The manufacturing shall be conducting under direct supervision of competent

technical staff and head of quality control laboratory.

1.4.6 HEALTH CLOTHINGS SANTATION OF WORKING :

All manufacturing operation shall be carried out under the supervision of

approached technical staff.

1.4.7 MANUFACTURING OPERATION AND CONTROL :

All manufacturing operation shall be carried out under the supervision of

approached technical staff.

1.4.8 PRECAUTIONS AGAINST MIX UP AND CROSS CONTAMINATION

The manufacturing environment shall be maintained at required level of temp.

humidity and cleanliness. The license shall maintained required level of temperature

humidity and cleanliness.

1.4.9 SANTATION IN THE MANUFACTURING PERMISES :

The manufacturing premises shall be cleaned and maintained in an orderly

manner free from accumulated waste, dust, debris and similar material.

1.4.10 RAW MATERIAL :

All the raw material shall purchased from approved sources under valid purchase

voucher. There shall be adequate separate area for materials under test, approved and

rejected.

1.4.11 EQUIPMENT :

Equipment shall be designed constructed, adopted and maintained to suit the

operation to carried out.

1.4.12 DOCUMENTATION AND RECORDS :

Documentation is essential part of Quality Assurance system and related to all

aspects of GMP. Its aim define the specification for all material, method of manufacture

and control.

1.4.13 LABEL AND OTHER PRINTED MATERIAL :

The level shall carry all prescribe details about the product. Different colour

coded label shell be used to indicate the status of product e.g. under test, approved pass

and rejected.

1.4.14 MASTER FORMULA RECORDS :

There shall be master formula record to related all manufacturing procedure.

a) The name of products together with reference code.

b) The patent and or proprietary name of product with generic name a description of

dosage from strength, composition.

c) Name, Quantity and reference number of all staring material.

d) A statement of expected final yield.

e) A statement of processing location.

f) Methods used for preparation of critical equipment.

g) The requirement for storage condition for product including container, labeling

and special storage condition.

h) Any special precaution to be observed.

CHAPTER 2

TABLET SECTION

2.1 SPECIFIC REQUIREMENT OF PLANT AND

EQUIPMENT : SCHEDULE – M

A minimum area of 60 sq. meter basic installation and 20 sq. meter is

recommended for uncoated tablet.

For coated tablet 30 sq. meter for basic installation and 10 sq. meter ancillary

area.

The tablet production department divided in to four distinct section.

2.1.1 Mixing, Granulation and Drying

2.1.2 Tablet compression section

2.1.3 Packaging Section

2.1.4 Coating Section

Machineries used in different section according to GMP are following.

1. Mixing and Drying –

a. Disintegrator

b. Sifter

c. Powder Mixer

d. Mass Mixer

e. Fluidized Bed Dryer

f. Hot Air Oven, weighing Machine

2. Compression Section -

Single Multipunch Rotatary compression machine, de-duster, Impection,

Single pan electronic Balance, Hardness Tester, Friability and Disintegration,

Test apparatus, Air conditioning and De humidification.

3. Packing Section -

Strip / Blister Pack Machine, leak test apparatus, tablet counter, air

conditioning and denumidification arrangement.

4. Coating Section -

Jecketed kettle, coating pan, polishing pan, exhaust system, weighing balance,

air conditioning and denumidification.

Definition:

Tablet may be defined as solid Pharmaceutical dosage form containing drug,

substance with or without suitable diluents prepared by either compression or molding

method.

Compressed and dispersible tablets are manufactured in Swiss Medicare Pvt. Ltd.

Tablets sections are divided into following sections. According Schedule M in

Swiss Medicare Pvt. Ltd.

Granulation Section

Compression / Tabletting Section

Coating Section

Packaging Section

2.2 GRANULATION SECTION

In SMPL preparation and drying of granules are done in this section. Equipments

use for granulation and drying are :

a) Sifter Machine

b) Mass Mixer

c) Multi Mill

d) Fluidized Bed Dryer

e) Double Cone Blender

Way of Processing of Granules are as follows :

i) Sifting :-

Weighed amount of raw material were sieved with a specific number of

sieves. The sifter machine which was present in SMPL has capacity of 30 to 300 kg.

per hour.

ii) Mixing :-

The sieved materials along with diluents and portion of disintegrants were

than mixed uniformly by mass mixer. Mass Mixer made by stainless steel and had a

removable cover at the top.

After appropriate mixing granulating agent starch gelatin paste added to form

a uniform wet mass of granulation. Preparation of starch gelatin paste as follows :

* Gelatin Paste –

i. Firstly gelatin added in a small water.

ii. In an another S.S. container boils the water near about 100OC.

iii Than mix the step i and ii and stir about 20 minutes.

* Starch Paste –

i. Firstly sieve the starch by # 80 or 100.

ii Mix with water

Mix Starch and Gelatin Paste.

This uniform wet mass is put to Multi Mill for granulation

Tablet – I

LIST OF BINDER

S.No. Name % used Solvent

1 Gum Acacia 2-5 Water , Alcohol water

2 Traga Canth 1-3 Water (mucilage)

3 Gelatin 1-4 Water

4 Sucrose 2-20 Water

5 Starch 1-4 Water (Paste)

6 Sodium Alginate 3-5 Water

7 Ammonium Calcium Alginate 3-5 Water

8 Methyl cellulose 1-4 Water

9 Sodium Carboxymethylcellulose 1-4 Water

10 Ethyl Cellulose 0.5-2 Alcohol

11 Hydroxy propylmethylcellulose 1-4 Water, Alcohol-water, chloroform, methylene chloride and mixtures with alcohol

12 Polyvinylpyrrolidone 2-5 Water, Alcohol, Alcohol-water

13 Magnesium aluminum silicate 3-5 Water (Slurry)

Table – II

RELATIVE PROPERTIES OF SOME TAB. LUBRICANTS

S.N. Material Usual % Glidant

Properties

Anti

Adherent

Lubricant

Properties

1 Metallic Stearates 1 or less Poor Good Excellent

2 Talcum 1-5 Good Excellent Poor

3 Stearic Acid 1-5 None Poor Good

4 High Melting Waxes 3-5 None Poor Excellent

5 Corn Starch 5-10 Excellent Excellent Poor

Table – III

WATER SOLUBLE TABLET LUBRICANTS

S.No. Lubricant Suggested %

1 Boric Acid 1

2 Sodium Chloride 5

3 Sodium Benzoate 5

4 Sodium Acetate 5

5 Sodium Oleate 5

6 Polyethlene Glycol 4000 1-4

7 Polythelene Glycol 6000 1-4

8 D’ l-Leucine 1-5

iii) Formation of Granules :-

There were three methods generally use for granulation :

a) Moist Granulation Method :-

The powdered medicaments along with other excipient, such as, diluent,

binding agent and a part of the disintegrating agent were moistened with a

sufficient quantity of granulating agent in order to make a coherent mass. The wet

granules were then spread in trays and dried at 60OC in F.B.D. The dried granules

passed through sieve number 20 to collect the granules of uniform size. The

lubricating agent, any volatile substance and the remaining part of the

disintegrating agent mixed. These granules were then ready to be compressed.

b) Dry Granulation Method :-

This method of granulation followed for those substances which were

sensitive to moisture and heat. The various steps were involved in Dry

Granulation method slugging.

c) Slugging Method :-

This method used in those cases where the medicament was unstable in

presence of moisture. In this process the dry powder compressed into large

tablets of “Slugs”. These slugs were broken into small pieces which passed

through a specified sieve to collect the granules of suitable size. A lubricating

agent and a disintegrating agent were mixed with these granules before

compression into the tablet machine.

iv) Sieving of Granules :-

Then prepared granules were passed through a screen of desired mesh size.

v) Lubrication of Granules :-

In sieved granules lubricants and glidants were mixed thoroughly. Then the

prepared lubricated granules sent to the Tabletting section.

DETAILS OF EQUIPMENTS WHICH ARE USED IN GRANULATING

SECTION

1. SIFTER MACHINE :-

Fig. TS1 – Sifter Machine

STANDARD OPERATING PROCEDURE (SOP)

Name of Machine : Sifter Machine

Make : CIP Machiners Pvt. Ltd.

Model : CSGS 20 inch, GMP with LID of SS 304

Capacity : 30 to 300 kg/hr.

Operation :-

1. To ensure the machine shall be cleaned and free from unwanted material from

last batch.

2. The machine should be free from appropriate batch size of screen depends

requirements of final products.

3. The machine should be run ‘light’ i.e. without placing any material to be

sieved in the hopper, for fifteen minutes.

4. The machine should be loaded only after the running in period.

5. Collect the screened product in suitable polythene lined container.

6. Periodic checking of vibration of machine and its position on started is

advisable as free precautionary measure.

2. MASS MIXER :-

Fig. TS2 – Mass Mixer


Name of Machine : Mass Mixer


Model : ---------------

Capacity : ---------------

Operation :-

1. Load the material from the container into the bowl as per the sequence

specified in the individual product batch manufacturing record.

2. Close the lid. Lock the three locking clamps.

3. Put the main switch on.

4. Before the starting the operation of the mixer ensure that it is cleaned as per

work instruction.

5. Load the materials and close the lid.

6. Start the dry mixing and run the mixer for 15 minutes.

7. At the binder paste / binder solution by opening the observation lid.

8. Selection of the time depends on what is specified in the individual BMR.

9. Add additional water it required and do the further mixing.

3. MULTI MILL :-

Fig. TS3 – Multi Mill


Name of Machine : Multi Mill Machine


Model : GMP, SS 304 contact parts

Capacity : ------------------

Operation :-

1. To ensure the machine shall be cleaned and free from unwanted material from

last batch.

2. Start the machine either in forward or reverse depending on size reduction to

be carried out .

3. Charge production into the hopper.

4. Open slide value slowly let the product enter the chamber.

5. Regulate the input by adjustment of slide value.

6. Maximum uniform output can be obtained by maintaining a constant rate of

feeding.

Caution !!!

OVEN FEEDING MAY JAIM THE ROTAR AND BEATERS AND DAMAGE THE

SCREEN

4. FLUIDIZED BED DRYER :-

Fig. TS4 - Fluidized Bed Dryer

In fluidized bed dryer, hot air (gas) if passed at high pressure through a performed

bottom of the container containing granules to be dried. The granules are lifted from the

bottom and suspended in the stream of air. This condition is called fluidized state.

5. DOUBLE CONE BLENDER :-

Fig. TS5 - Double Cone Blender

a) Two cones are joined to a small cylindrical section.

b) This overcome slow horizontal movement of solids found in a cylindrical

mixer.

c) Due to conical shape good rolling action of the solids prevail.

2.3 COMPRESSION / TABLETTING SECTION

This was constant humidity and temperature section which consist 20 station

rotary tablet machine.

Granules received from granulating section were compressed in unit dosage form

by this machine. A rotary tablet machine has a circular rotating head, carrying a number

of punch and dies assembles. The head revolves continuously while the table granulation

runs from the hopper through a feed frame and into the dies placed in a large steel plate

revolving under it. There was a uniform filling of the die due to this arrangement and

therefore the tablets formed in rotary tablet machines have an accurate uniform weight.

The compression of granules takes place as the upper and the lower punches pass

between a pair of rollers. The tablet comes out when the lower punch lifts up.

A dust exhauster attached separately with the rotary tablet machine, which stop

the dust spreading in the section.

Fig. TS6 - Rotary Tablet Machine


Name of Machine : Rotary Tabletting Machine


Model : CIP 3, RY 20 station GMP Model

Capacity : 18000 to 50400 Tablet / hrs.

Operation :-

1. To ensure the machine shall be cleaned and free from unwanted material.

2. Fit the hopper with punches and dies of machine according to desirable shape and

size of tablets.

3. Fill the hopper with material to be compressed and adjust height of hopper to

obtain a flow of the material into the feed frame.

4. Slacken off the pressure adjusting wheel then rotate the machine hand wheel

manually until it is observed that powder is being ejected from the dies in the line

with the tablet discharging spent.

5. Re-adjust the pressure adjusting wheel sufficiently to produce formed tablets.

6. These tablets is weighted or measured will indicate what regulation is required to

be made to be dozer wheel and pressure adjusting wheel 50 that the tablet of the

desired weight and degree of hardness can be obtained.

7. When the machine running under the power it will be observed that the powder

from the hopper partly fills each compartment of the feed frame and that the

scraper plate on the rear compartment deflects the excess powder that is adjusted

from the die cavity, when the lower punches pass over the dozer to the inner part

of dies plate. The power is carried round on the die plate and returned to the front

of the feed frame.

A tablet testing room was adjusted with double door entry, one from compression

section and other from granulating section. This room have following testing

equipments :-

1. Vernier Calipers

2. Friabilator

3. Hardness Tester

a) Monsanto

b) Pfizer

4. Analytical Balance (Dona® Balance)

5. Dissolution Test Apparatus I.P./USP

6. Disintegration Test Apparatus I.P./USP(D.T.)

All the equipment are calibrated and passed through validation process as

per official books.

To maintain quality of tablet various inprocess quality control test as per

I.P. 96 are done which are as follows :

1. Shape and Size

2. Uniformity of Weights

3. Dissolution Test

4. Hardness Test

5. Disintegration Test

6. Friability Test

7. Weight Variation Test

After these specific in process quality control tests, the tablets are sent to the

coating section if required or to the packaging section.

2.4 COATING

Fig. TS7 - Coating

Coating pan was available in Swiss Medicare Pvt. Ltd. There was a separate room

for coating which had double door entry. This room had humidity and temperature

according to GMP guide lines.

The following is list of numerous tablets product manufacture in Swiss Medicare

Pvt. Ltd.

TABLE – IV

LIST OF TABLETS MANUFACTURED IN SWISS MEDICARE PVT.LTD.

S.No. COMPOSITION S.No. COMPOSITION

1. ASTHACURE TABS

Each uncoated tab. contains

Salbutamol Sulphate I.P. …….. 2 mg.

5. DICLOTAB-PLUS TABS


Diclofenac Sodium I.P.. ……… 50 mg.

Paracetamol I.P…………..……500 mg.

2. CITIZEN – DT TABS

Each dispersible tab. contains

Cetirizine dihydrochloride. …. 10 mg.

6. STEMINOL TABS


Prochlorperazine Maleate I.P. ..... 5 mg.

3. COLITAB TABS


Dicyclomine HCL I.P.. …….. 20 mg.

Paracetamol I.P………………500 mg.

7. DOMFAST-CZ TABS

Each dispersible tab. contains

Cinnarizine I.P………….... ….. 20 mg.

Domperidone B.P……….……. 15 mg.

4. COZYTAB-PLUS TABS


Cholorphenirame Maleate I.P. …. 2 mg.

Phenylephrine HCL I.P……..…. 10 mg.

Caffine (Anhydrous) I.P…..…… 30 mg

Paracetamol I.P………………. 500 mg.

8. STUGENOL TABS


Cinnarizine B.P…………. ….. .75 mg.

The production manager maintain following record in tablet section.

1. Master Formula and Batch Processing Record

2. Raw Material Issue Sheet

3. Packaging Material Sheet

4. Sheet for Finished Goods Store Room

2.5 PACKAGING SECTION

The finished tablets which was received after passing the quality control test were

packed into various forms of packaging.

There were two type of packaging systems present in Swiss Medicare Pvt. Ltd.

1. Strip Packaging

2. Blister Packaging

Fig.- Blister Packaging Machine Fig.- Strip Packaging Machine

Both of two machines were semi automatic machine. In both machine tablets

were loaded manually but rest process is automatic.

After Strip and Blister Packaging, the product is packed into unit boxes of 20 strip

or 20 blister or any other quantity. The finished product is then sent to the finished good

room.

SWISS MEDICARE PVT.LTD.F.-350 & 351 (A), Phase-II, Industrial Area, RIICO, Sri Ganganagar (Raj.)

BATCH MANUFACTURING RECORD(As per Schedule U & GMP)

Name of Product : STEMINOL TAB.

Batch Size 4,94,000 Tabs. B.No 79506 Master Formula Ref. No. - ……

Room Temp 30O R H 45O Date of Commencement : 6/6/06

INDREDIENTS Label Claim

C.R. No.

Qty. Regd. Qty. Used Stock Ledger

Kg. Gm. Kg. Gm.

Active Ingredients

Each uncoated tablet contains :

Prochlorperazine Maleate I.P.

5 mg 2 470 2 470

FILLERS

Starch I.P.

130 mg. 64 220 64 220

Di Cal. Phos. I.P.

Lactose I.P.

Talcum 65 mg. 32 110 32 110

Date of Mixing : 6/6/06 Duration : 1 hrs. Total Wt = 98780 Kg.

PASTE (Blinder)

Starch 10 % 4 500

Gelatine 4 % 2 000

Sod. Benzoate 1 976

Colour No

Date of Granulation : 6/6/06 Dried at – 65O Temp.

Time Required 2 to 3 Hrs. Weight of dried granules : 105.270 Kg. (Theoretical)

104.500 Kg. (Practical)

LUBRICANTS

Starch 4 120

Talcum 4 000

Mag. Stearate 1 000

TOTAL WT. = 113.620 kg.

Weight of Lubricated Granules = 113.600 Kg.

Added Lubricated Granules of previous batch No………… = ……….. Kg.

(wt. per tablet………………………….mg)

Total Weight of Lubricated granules ready for compression = 113.600 Kg.

Compression :

Date of Compression : 6/6/06; 7/6/06

Weight of One Tablet should be 230.mg.

Punch Size Die ………………Width Length…………………………

Appearance : White colour circular Surface : Biconvex Uncoated

Scored : On One Side Embossed : Swiss on upper side

Hardness : 3 to 3.5 Kg./Cm2. Disintegration Time : 1 to 2 Minutes

Friability : 0.64 %

Weight of 20 Tablets : 4.660 gm.

Average weight per tablet : 233 mg.

Permissible limit of wt. variation - 2141 mg. to 248.8 mg.

Individual wt. of 20 tablets in mgs.

231 232 230 230

230 233 232 232

230 235 232 232

231 234 230 234

232 238 234 234

PACKINGS

Date……………………

No. of Box Qty. per Box Total Tablets

_______________________________________________________________________

_2169_________________________20 X 10 ___________________________________

Samples_________________________________________________________________

_____________________

For Quality Control Deptt. _____________________

Total = ____433800___________

Percentage yield Date of Completion _____________________

Quality released to warehouse

PACKING MATERIAL QTY. USED

Particulars

PVC : 78 mm

88.00 M

Aluminium Foil Material 18.50 M

Mfg. Date : June 2006, Exp .Date : June 2009

Signature Assistant Mfg. Chemist Signature Analytical Chemist

Label Specimen

2.5 BATCH MANUFACTURING RECORD – NIMULET PLUS

SWISS MEDICARE PVT.LTD.F.-350 & 351 (A), Phase-II, Industrial Area, RIICO, Sri Ganganagar (Raj.)

BATCH MANUFACTURING RECORD(As per Schedule U & GMP)

Name of Product : NIMULET PLUS

Batch Size……………… B.No. 64508 Master Formula Ref. No. - 64

Room Temp 33O R H 42O Date of Commencement : 16/7/06

INDREDIENTS Label Claim

C.R. No. Qty. Regd. Qty. Used Stock Ledger

Kg. Gm. Kg. Gm.

Active Ingredients

Nimesulide B.P. 100 mg. SMP/56/3/05 15 00 15 00

Paracetamol B.P. 500 mg. SMP/56/5/05 75 00 75 00

Date of Mixing : 16/7/06 Duration : 1 to 2 hrs. Total Wt = 90 Kg.

PASTE (Blinder)

Starch 10 % 2 00 2 00

Gelatine 6 mg. 900 900

Sod. Benzoate

Colour No

Date of Granulation : 16/7/06 Dried at – 60O Temp.

Time Required : 2 to 3 Hrs. Weight of dried granules : 92.800 Kg.

LUBRICANTS

Starch

1 250

Talcum

1 00

Mag. Stearate

950

TOTAL WT. = 96.00 kg.

Weight of Lubricated Granules = 96.00 Kg.

Added Lubricated Granules of previous batch No………… = 00.00 Kg.


Total Weight of Lubricated granules ready for compression = 96.00 Kg.

Compression :

Date of Compression : 17/7/06

Weight of One Tablet should be 640.mg.

Punch Size Die ………………Width Length…………………………

Appearance : Pale Yellow elongated Surface : Biconvex Uncoated

Scored : On One Side Embossed : …………………

Hardness : 5 to 6 Kg.2 per Cm. Disintegration Time : 3 to 4 Minutes

Friability : 0.61 %

Weight of 20 Tablets : 12.840 gm.

Average weight per tablet : 642 mg.

Permissible limit of wt. variation 6099 mg. to 6741 mg.


642 650 642 649 647

645 643 644 645 650

648 647 645 642 646

648 649 648 643 648

647 644 643 644 650

QUALITY CONTROL

Sample tested by _________________________________________________________

Analytical Report No.__________________________Date________________________

Result – Passes / Fails

Date of release for ware house______________________________________________


PACKING NO. OF BOXES STOCK LEDGER

Date of Completion ____________________


Label Specimen

FLOW CHART OF TABLETS PRODUCTION

Production Order

↓Dispensing of Raw Material

↓Weighing

↓Sifting

↓Mixing

↓Preparation of Wet Mass

↓Binding

↓Wet Granulation

↓Drying

↓Size Reduction

↓Mixing of Lubricants

↓Lubrication of Granules

↓Compression

↓In Process Checking

↓Packing Order

↓Dispensing of Packing Material

↓Strip / Blister sealing

↓Strips ready Cartooning

↓Cartons transferred to Finished Goods Room

CHAPTER 3

LIQUID SECTION

3.1 SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL

LIQUIDS ACCORDING TO GMP

The layout and design of the manufacturing area shall strive to minimize the risk

of cross-contamination and mix-ups. Manufacturing area shall have entry through double

door air-lock facility and made fly-proof by use of ‘fly-catcher’ and/or ‘air-curtain’. The

production area shall be cleaned and sanitized at the end of every production process.

Equipment design shall be such as to prevent accumulation of residual microbial growth

or cross-contamination. The use of glass apparatus shall be minimum.

The chemical and microbiological quality of purified water shall be specified and

monitored routinely. The microbiological evaluation shall include testing for absence of

pathogens and shall not exceed 100 cfu/ml. There shall be a written procedure for

operation and maintenance of the purified water system. Care shall be taken to avoid the

risk of microbial proliferation with appropriate methods like re-circulation, use of UV

treatment, and treatment with heat and sanitizing agent.

Manufacturing personnel shall wear non-fibre shedding clothing to prevent

contamination of the product Materials likely to shed fibre like gunny bags or wooden

pallets shall not be carried into the area where products or cleaned containers are

exposed. The primary packaging area shall have an air supply filtered through 5 filters

and the temperature shall not exceed 30OC. When the product was not immediately

packed, the maximum period of storage and storage conditions shall be specified in the

Master Formula.

* Monophasic Liquid (Syrup, Expectorant)

* Biphasic Liquid (Suspension)

Swiss Medicare Pvt. Ltd. manufactured wide range of liquid product i.e. syrup

suspension, expectorant etc. Liquid Section was sub divided into following areas :

Bottle Washing Area

Formulation Section

Filling and Sealing Area

Labeling Area

Packaging Section

3.2 BOTTLE WASHING AREA

In Bottle Washing bottles were washed with bottle washing machine by using hot

water. This was fully automatic machine which washed the twelve bottles at a time. This

machine thrown the hot water to inside the bottles with pressure and cleaned them.

After washing the bottles were dried at about 50OC in hot air dryer.

The completely dried bottles and glass wares were sent to filling section as per

requirements.

3.3 FORMULATION SECTION

3.3.1 Formulation for monophasic liquids :-

The formulation of solutions presents many technical problems to the industrial

pharmacist. Some drugs were inherently unstable; this property was magnified when the

drug was in solution. Special techniques were required to solubilize poorly soluble

drugs. The final preparation must satisfy the requirements of pharmaceutical elegance

with regard to taste, appearance, and viscosity.

FORMULATION CONSIDERATIONS -

a) Solubility :-

Solubility studies are generally conducted at fixed temperatures, preferably at

temperatures some what higher than room temperature e.g. 30OC, so that constant

conditions can be maintained regardless of normal laboratory temperature variations.

During the normal distribution process, however, it is possible and even likely that the

product will be exposed to a wide range of temperature conditions. For this reason,

information relative to the influence of temperature on solubility should be generated. As

a rule, a solution should be designed in which the solubility of the solute is not exceeded

even at temperatures as low as 4OC.

b) pH :-

A large number of modern chemotherapeutic agents are either weak acids or weak

bases. The solubility of these agents can be markedly influenced by the pH of their

environment. Through application of the law of mass action, the solubility of weakly

acidic or basic drugs can be predicted, as a function of pH with a considerable degree of

accuracy.

c) Cosolvency :-

Weak electrolytes and nonpolar molecules frequently have poor water solubility.

Their solubility usually can be increased by the addition of a water-miscible solvent in

which the drug has good solubility. This process is known as cosolvency and the solents

used in combination to increase the solubility of the solute are known as cosolvents. The

mechanism responsible for solubility enhancement through cosolvencyc is not clearly

understood. It has been proposed that a cosolvent system works by reducing the

interfacial tension between the predominately aqueous solutions and the hydrophobic

solute.

Cosolvents are employed not only to effect solubility of the drug, but also to

improve the solubility of volatile constituents used to impart a desirable flavor and odor

to the product.

d) Solubilization :-

In recent years, the application of solubilization phenomena to pharmaceutical

systems has greatly increased. Table-V shows the type of solubilizing agents most

frequently used in pharmaceutical systems and the types of drugs for which these agents

are effective. The acceptability of these surfactants for oral use should be determined on

an individual basis.

TABLE – V

SOLUBILIZING AGENTS USED IN PHARMACEUTICAL SYSTEMS

Solubilizer Solubilizate

Polyoxyethylene Sorbitan Phenobarbiton

Fatty aicd esters Barbital

Caffeine

Benzocaine

Chlormphentcol

Chloroform

Digitoxin

e) Complexation :-

Organic compounds in solution generally tend to associate with each other to

some extent. Frequently, this association is too weak to be detected by standard

techniques. In other cases, the intermolecular association, or complex, an be readily

observed and quantitated by one or more of numerous published techniques. One of the

more widely used methods, and one that is highly germane to this discussion, is the

solubility analysis technique.

Consider the interaction between a drug, D and a complexing agent, C :

xD + yC DxCy

Where X and Y denote the stoichiometry of the interaction. For simplicity, only

the case in which one species of complex is formed is considered here; it is possible for

several species of complexes to coexist.

The total solubility of drug in this case is :

Sr = [D] + X [DxCy]

Where [D] = the solubility of uncomplexed drug

= Ks

X[DxCy] = concentration of drug in complexed form.

By use of the solubility analysis technique, the stoichiometry of this interaction as

well as its equilibrium constant, can be determined.

f) Hydrotrophy :-

The influence on large concentrations of sodium benzoate on the solubility of

caffeine is a classic example of this phenomenon applied to a pharmaceutical system.

Accurately weighed raw materials were received from the raw material store

room according to the master formula sheet, for formulation of liquid preparation. In

formulation of liquid always freshly prepared purified water was used (in SMPL this

water is produced by ion exchange method). The simple syrup I.P. was used for

sweetening agent. The formulation preparations were filled by filter press and the sieving

method according to the liquid preparation and there particle size range. Then prepared

preparation sent to the filling and sealing section.

Generally pineapple favour used for preparation of syrups in SMPL.

3.3.2 Formulation for biphasic liquids :-

Biphasic liquid preparation passed throw colloid mill for conversion in fine

particle (ranging from 0.5 to 5 ) from large particle. This size range is checked by

microscopy method in SMPL. Then prepared preparation added to a drum (60 lt. capacity

in SMPL). A propeller mixer was attached on upper side of the drum which rotate in the

drum at very high speed. Then prepared preparation sent to the filling and sealing area.

Generally mango flavour was used for suspension in SMPL.

3.4 FILLING AND SEALING AREA

The finished formulated preparation received from the formulation section were

filled in the bottles by semi automatic liquid filling machine. The volume the filed

preparation fixed by the automatic handle of liquid filling machine.

After filling the specific quantity in the container glass, bottles were sealed by

semi automatic cap sealing machine. During the channel of formulation of liquid

preparation to the filling into containers, there were various in process quality control test

done. They were as follows :

2.1.5 pH Maintaining Test : By Ph Meter

2.1.6 Volume Test : By volumetric Flask

2.1.7 Colour and Flavour Test : By Production Manager’s inspection

2.1.8 Foreign particle impurity test : Against white and black background.

3.5 LABELLING AREA

Labels were pasted on the bottles with the help of labeling machine. A good

quality natural gum was used for this purpose. Before pasting the level on the bottles

Exp. Date, Mfg. Date, Batch No. printed with a hand operated printing machine in

SMPL.

3.6 PACKAGING SECTION

Container were packed in suitable size boxes after labeling.

Production Manager maintained following record in the liquid section.

a) Master formula and Batch Processing Report.

b) Raw material issue sheet.

c) Packaging Material Sheet

d) Sheet for finished goods Store room.

DETAILS OF EQUIPMENTS

(i) Colloid Mill :-

a) A colloid mill consists of a stator and a rotor with conical working surfaces.

b) The clearance between the rotor and the stator is adjustable and varies from

0.002 to 0.03 inches.

c) The rotor speed is 3000 to 20000 R.P.M.

d) In SMPL colloid mill is used for processing suspensions.

(ii) Propeller Mixer :-

b) Propeller mixer are most widely used for liquids of low viscosity.

c) Propeller is small in relation to container. Propeller to container ration of 20

is satisfactory for mobile liquids.

d) Propeller mixers are operates at very high speed up to 8000 RPM.

e) Propeller mixers produced the longitudinal movement of the liquid and

produce little shear.

f) Flow pattern is axial.

g) Central vertical propeller produce only rotary motion and draw a vortex

toward the propeller.

(iii) Filter Press :-

It consists of plates and frames. It is used for materials to be filtered. Plate has a

grooved surface which gave support to the filter cloth. The plate and frame can be made

of various metals which provide resistance to corrosion or prevent metallic contamination

of the filtrate. Filter cloth is fitted on each side of the plate. The plates and frames are

placed alternatively and fitted in the outer frame of the press. Each plate acts as a single

filtration unit.

The filtrate collected in the plates from where it collected through common outlet

pipe. The cake deposited in the frames. The process of filtration continued until the

frame filled with filter cake. When the process stopped, the frame emptied and the cycle

restarted.

(iv) Liquid Filling Machine :-

Fig. - Liquid Filling Machine

This machine is used for filling the liquid in container. Capacity of this machine

was 250 ml. in one stroke (in SMPL).

(v) Cap Sealing Machine :-

This was a semi automatic machine which is used for seal the cap of the bottles.

(vi) Rotary Labeling Machine :-

This machine had a rotar which rotate continuously. This machine is use to fix

the label on bottles.

TABLE - VI

LIST OF LIQUIDS MANUFACTURED IN SWISS MEDICARE PVT. LTD.

S.No. COMPOSITION S.No. COMPOSITION

1. ASTHACURE-PLUS SYP

Each 5 ml contains

Salbutamol Sulphate I.P. …….. 1 mg.

Etophylline I.P………………..100 mg

Bromhexine HCL I.P………… 4 mg.

3. COLITAB SUSP

Each ml contains

Dicyclomine HCL I.P.. ……… 10 mg.

Activated Dimethicone I. P……40 mg.

2. COZYTAB-PLUS SYP

Each 5 ml contains

Cholopheniramine Maleate I.P. …1 mg.

Phenylephrine HCL I.P………..2.5 mg

Paracetamol I.P………………..125 mg

4. NIMULET-ORAL SUSP.

Each 5ml contains

Nimesulide………………....... 50 mg.

FLOW CHART OF LIQUID

Production Order

↓

Release of Raw Material

↓

Rechecking of Weight

↓

Syrup manufacturing

↓

Dissolving of ingredients

↓

Sampling and Testing of Bulk Preparation

↓

Filling of preparation into container

↓

Sealing of Container

↓

Clarity Test

↓

Labeling

↓

Packed in Cartons

↓

Send to the finished goods room

CHAPTER 4

QUALITY CONTROL SECTION

Swiss Medicare Pvt. Ltd. has a separate quality control department, which

supervised by expert staff directly responsible to the managing body but independent of

other department. Q.C. Department could control the raw materials, monitor all in

process quality check and controlled the quality stability of finished products.

This department evaluate the quality and stability of raw material as well as

finished and stored project. This department could release or reject the each batch of raw

material, finished and semi-finished products when necessary.

Usually two samples were chosen randomly from each batch of tablets and

liquids. The first sample met for immediate quality control testing, whereas second

sample was intended to be maintained under appropriate storage conditions to determine

whether or not the sample obey the jurisprudence of the Drug and Cosmetic Act’s various

rules, over pre decided and distinct period of time.

Several equipments used for these various in process checking in Q.C.

Department.

For Tablets :-

1. Friabilator 2. Analytical Balance (Dona® Balance )

3. Monsanto Hardness Tester 4. Pfizer Hardness Tester

5. Disintegrator 6. Dissolution Test Apparatus

For Liquids :-

1. pH Meter 2. Clarity Test Bench

3. Measuring Cylinders

For Raw Material and Raw Material and Analytical Purposes :-

1. Burettes 2. Pipettes

3. Beakers 4. Volumetric flask

5. Funnel 6. Weighing Bottle

7. Hot Air Oven 8. Electrical Burner

9. Centrifugal Machine 10. Polarimeter

11. Melting Point Apparatus 12. pH Meter

13. Vacuum Oven 14. UV-VLS Spectrophotometer

15. Chemical, Indicator & Titrants

CHAPTER 5

STORAGE HOUSE

5.1 RAW MATERIALS STORE ROOM

The store room is place where various materials are stored and preserved until

they are issued to other departments. This unit had a centralized store room consisting of

a better control, better layout, less space, staff, economy and better stock checking was

rendered.

The storeroom was almost in the center of the unit and near the section so that

transportation of raw materials from store to various sections become very easy &

economic. In generally it consists of bulk drugs, raw materials coloring agents, flavoring

agents, sweetening agents, various suspending agents tools and spare parts of machine

etc.

The materials such as coloring and flavoring agents, patent drugs, tools stored in

specific metal, plastic, rubber and cardboard boxes in shelves and racks. The store

categorized in zones for proper handling of the material.

The materials issued to the production departments and the other departments as

and when desired by them. This section also maintains an upto date record of receipts

and issue of materials. The materials issued from the store recorded. For maintaining an

up to date records, a store ledger used. It provides information regarding the A/c number

of item, description of item, maximum, minimum and recorder and recorder level,

quantity received with date, quantities issued with date, batch no. regarding the materials

used all other necessary information.

5.2 PACKAGING MATERIAL STORE ROOM

An independent packing materials preparation and storage arrangements systems

was available at Swiss Medicare Pvt. Ltd., SGNR. There were two packaging material

store present in SMPL –

(i) Packaging Material Store - Printed : Printed packaging material were

held here.

(ii) Packaging Material Store – Unprinted : Unprinted packaging material

were held here.

The packing materials included bottles, plastic boxes, polythene, bags, containers,

labels, cardboard strips and cartons etc. use for packing in SMPL. Moreover, its constant

inventory checked by factory manager time to time.

5.3 FINISHED GOODS STORE ROOM

In this room finished product received from packaging material store room and

then the products sent to market for selling through selling executives and marketing

executives.

CHAPTER 6

DOCUMETATION SECTION

Documentation and records :

Documentation is an essential part of the Quality Assurance system and, as such,

shall be related to all aspects of Good manufacturing practices (GMP). Its aim is to

define the specifications for all materials, method of manufacture and control, to ensure

that all personnel concerned with manufacture know the information necessary to decide

whether or not tot release a batch of a drug for sale and to provide an audit trail that shall

permit investigation of the history of any suspected defective batch.

i) Documents, designed, prepared, reviewed and controlled, wherever applicable,

shall comply with these rules.

ii) Documents shall be approved, signed and dated by appropriate and authorized

persons.

iii) Documents shall specify the title, nature and purpose. They shall be laid out in an

orderly fashion and be easy to check. Reproduced documents shall be clear and

legible. Documents shall be regularly reviewed and kept up to date. Any

alteration made in the entry of a document shall be signed and dated.

iv) The records shall be made or completed at the time of each operation in such a

way that all significant activities concerning the manufacture of pharmaceutical

products are traceable. Records associated standard operating procedures (SOP)

shall be retained for at lease one year after the expiry date of the finished product.

v) Data may be recorded by electronic data processing systems or other reliable

means, but Master Formulate and detailed operating procedures relating to the

system in use shall also be available in a hard copy of facilitate checking of the

accuracy of the records. Wherever documentation is handled by electronic data

processing method, authorized persons shall enter or modify data in the computer.

There shall be record of changes and deletions. Access shall be restricted by

‘passwords’ or other means and the result of entry of critical data shall be

independently checked. Batch records electronically stored shall be protected by

a suitable back-up. During the period or retention, all relevant data shall be

readily available.

6.1 DOCUMENTATION - FOR FINISH PRODUCTS

1. First of all prepared the batch of given drug formulation. After the produces

of finish product packed into suitable container and after that packed into

carrougeted Box (cases) and before the packing of product, carry the

calculation for finish good.

B. Prepared the Finish Good Documentation Slip :-

i) Finished Good Transfer Slip :-

Note :- All work done under I.P.Q.C. and Production department and prepared 4 copies

of every document.

1st Copy for self documents

2nd Copy for store or finish goods departments

3rd Copy Q.C. Office

4th Copy as official documents

Example :-

A. Bach complete or Incomplete :-

Product Name = ACTIREX

Salt Name = Chlorpheniramine Maleate Expectorant

Quantity in each bottle = 2.5 mg.

Demand = 400 liters (4,00,000 ml)

Quantity in Per Bottle = 100 ml

Amount of Total Bottle = 4000 Bottles

(After produces of finish product)

Total = 82

Bottle in per case = 48

Total Bottles = 3936

Total Quantity of Finish Product = 3936 X 100 = 3,93,600 ml

Demand Quantity of Finish Product = 4,00,000 ml

% of Finish Product = 393600 / 400000 X 100 = 98.40 %

“Batch is completed”

Limit :- 100 – 98 % - Batch completed

Below 98% - Batch in-completed

6.2 DOCUMENTATION – IN Q.C. DEPARTMENT

In the Q.C. department, different test and assay carried on the product / bluck

sample / raw material. After the completion of test and assay, noted the results in the

record and prepared the documents (3 copies) and signed by the authorized person (Q.C.

Manager)

1st Copy for self documents

2nd Copy for I.P.Q.C. departments

3rd Copy as official documents

Documents on :- Examples

(i) Determine the % of claim of active ingredients in formulations of

products.

(ii) Determine the moisture contents in the given sample.

(iii) Determine the disintegration and dissolution time of given sample.

(iv) General testing of packing material.

SWISS MEDICARE PVT. LTD.351 & 350 (A), Udyog Vihar, RIICO, Sri Ganganagar (Raj.)

MASTER FORMULA RECORD“SCHEDUEL – M”

Name of the Product ……………………………..Dosage Form……………………..

Product Ref. Code ………………………………..MFR. No. …………………………

Generic Name (with composition)……………………………………………………...

Strength…………………………………………..

Commentment Date…………………………………

Approved by

Sign. Sign.

Q.C. Manager Production Manager

* Specification of Raw Materials

S.NO. NAME OF RAW MATERIAL

* Specifications of Containers, Closures, Labeling and Packaging Materials :-

S.No. NAME OF ITEM SPECIFICATION

Weighment Sheet :

S.No. Ingredients (in order of Mixing)

Specifications Qty. required as per label claim

Qty. to be used

Over ages

Remarks

1 2 3 4 5 6 7

Dispensing Instructions :-

* List of Equipment and Machinery

* Manufacturing Instructions including in process controls to be exercise

* Packaging Instructions :

* Finished Product Specifications :-

* Expiry Date :-

SWISS MEDICARE PVT. LTD.351 & 350 (A), Udyog Vihar, RIICO, Sri Ganganagar (Raj.)

BATCH PROCESSING RECORD

Name of Product…………………………… Dosage Form………………………….

Batch Size……………B.No.…………………M.F.R. No……………………..…….

Room Temp…….…..R H……………….Date of Commencement………..…………

INDREDIENTS Lable Claim

C.R. No.

Qty. Regd. Qty. Used Stock Ledger

Kg. Gm. Kg. Gm.

Active Ingredients

FILLERS

Starch I.P.

Dl Cal Phos. I.P.

Lacriose I.P.

Lactose I.P.

Talcum

Date of Mixing ………………Duration………………….. Hrs. Total Wt =……………….

PASTE (Blinder)

Starh

Gelatine

Sod. Benzoate

Colour (if added)

Date of Granulation ……………Dried at - ………………………………………………

Time Required …………………Weight of dried granules………………………………

LUBRICANTS

Starch

Talcum

Mag. Stearate

TOTAL WT. =

Weight of Lubricated Granules = …………….. Kg.

Added Lubricated Granules of previous batch No………… = …………….. Kg.


Total Weight of Lubricated granules ready for compression = Kg.

Compression :

Date of Compression………………….

Weight of One Tablet should be ………………….mg.

Punch Size Dia………………Width ………………Length…………………………

Appreance…………………………………………surface…………………………….

Scored………………………………………………….

Embossed………………………………………………

Hardness……………………………………kg/cm. Disintigration

Time………………………………………...

Friability ……………………………………%

Weight of 20 Tablets ………………………..gm.

Average weight per tablet………………………….

Permissible limit of wt. variation……………………………..


1 5 9 13 17

2 6 10 14 18

3 7 11 15 19

4 8 12 16 20

PACKINGS

Date………………

No. of Box Qty. per Box Total Tablets

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Samples______________________________________________________________

_____________________

For Quality Control Deptt. _____________________

Total = _____________________

Percentage yield Date of Completion _____________________

Packing Material Required

PARTICULARS QTY. USED DESTROYED TOTAL STOCK LEDGER

Boxes (Plastic)

Pouch

Labels

Strip Qty.

Cartoons

Catch Cover

Printed Particulars on Label Batch No._______________________Rate Stip =

500’s =

1000’s =

2500’s =

Mfg. Date_______________________Exp. Date ____________________________

QUALITY CONTROL

Sample tested by ____________________________________________________

Analytical Report No._________________________Date______________________

Result – Passes / Fails

Date of release for ware house____________________________________________


PACKING NO. OF BOXES STOCK LEDGER

Date of Completion ______________________


(Mr. ) (Mr. )

Label Specimen

In process Quality Control

Hardness of tablet_____________________kg/cm Friability____________________

Disintegration time__________________________

Wt. o 20 Tablets _____________________________gm.

Average Wt. per tablet ____________________ Claim________________________

Permissible limit of Wt._________________________

Wt. of 20 Tablets at intervals of 30 Minutes in gms.

1 2 3 4

5 6 7 8

9 10 11 12

13 14 15 16

17 18 19 20

Signature of Analytical Chemist

(Mr. )

CHAPTER 7

MARKETING MANAGEMENT

Marketing means striking a balance between demand and supply. It is the

process, which involves all direct or indirect forces of effects as conditions, which results

in the flow of goods or services from manufacturer to consumer.

Mr. Ravi Chadha (M.D. of SMPL) is the marketing manager of SMPL SGNR.

All of the products which are manufactured in SMPL are self marketed with the help of

several marketing executives.

Sister concern (Marketing concern) of SMPL is Swiss International Pvt. Ltd.

office of Swiss International is situated in Ahamdabad.

SMPL distribution network is extended in the entire. Country and hence products are

available in the remote area.

CHAPTER 8

OTHER ZONES

8.1 REFRESHMENT ROOM

This room used by the workers at the time of lunch.

8.2 PANTRY

Pantry / Kitchen used for making Tea, Coffee or any other Soft Drinks for the

Staff of the SMPL. Electrical Water Cooler was also present in pantry for fresh drinking

water.

8.3 CONFERENCE ROOM

This room used for conferences. Generally conferences addressed by M.D. and

Production Manager.

8.4 CHANGING ROOM

Separate changing room for men and women were present in SMPL. Both rooms

had many of drawers each worker of the company had their drawer.

CONTENTS

S.No. P. No.

1. ACKNOWLEDGEMENT i

2. LIST OF FIGURES iii

3. LIST OF TABLES iv

Chapter No.

1. INTRODUCTION 1

Corporate Profile 1

1.1.1 Company Layout 4-5

Managing Body 6

Production Unit 7

1.4 G.M.P. For Premises and Materials 8

2. TABLET SECTION 13

Specific Requirements for Manufacture of Oral Solid Dosage Forms 13

Granulation Section 15

Compression / Tabletting Section 23

Coating Section 26

Packaging Section 28

3. LIQUID SECTION 36

Specific Requirements For Manufacture Of Oral Liquids 36

according to GMP

Bottle Washing Area 37

Formulation Section 37

Filling and Sealing Area 41

Labelling Area 41

Packaging Section 42

4. QUALITY CONTROL SECTION 46

5. STORAGE HOUSE 48

5.1 Raw Materials Store Room 48

5.2 Packaging Material Store Room 49

5.3 Finished Goods Store Room 49

6. DOCUMENTATION SECTION 50

6.1 Introduction 50

6.2 Documentation for Finished Product 51

6.3 Documentation in Q.C. Department 52

6.4 Master Formula Record 53

6.5 Batch Processing Record 55

7. MARKETING MANAGEMENT 60

8. OTHERS ZONES 61

LIST OF TABLES

Table No. Page No.

1. Binders 15

2. Relative properties of some tablet Lubricants 16

3. Water Soluble tablet Lubricants 16

4. Tablets manufactured in Swiss Medicare Pvt. Ltd. 27

5. Solubilizing agents use in pharmaceutical system 32

6. Liquids manufactured in Swiss Medicare Pvt. Ltd. 37

LIST OF FIGURES

Figure No. Page No.

1. Sifter 18

2. Mass Mixer 19

3. Multi Mill Machine 20

4. Fluidized Bed Dryer 21

5. Double Cone Blender 21

6. Rotary Tablet Machine 22

7. Coating Pan 25

8. Blister Packaging Machine 28

9. Liquid Filling Machine 36

ACKNOWLEDGEMENT

I am grateful to Dr. T.R. Juneja, Principal of S.D. College of Technical Education,

Institute of Pharmaceutical Sciences and Drug Research, SGNR for giving me a chance

to look at the practical respect of industry and continuously gave me guidance and

encouragement.

I am deeply indebted to Mr. Vipin Kukkar, Deptt. Of Pharmaceutics (Industrial

Trainee Cell Incharge) for his invaluable guidance, consistent, encouragement,

constructive criticism, suggestions and kind cooperation through out of course of work.

It was great opportunity for us to work under his guidance.

I extend my special thanks to Mr. Ravi Chadha, M.D. Swiss Medicare Pvt. Ltd,

SGNR for their cooperation and timely suggestions.

I wish to place on record my sincere thanks to Mr. Raj Lamba (H.R.) Swiss

Medicare Pvt. Ltd. for providing information about the machinery, location, discipline

and guideline in the factory.

I am grateful to Mr. Baldev Singh Kakkar (Factory Manager), Mr. Arun Sharma

(Production Manager), Mr. Jagdish Choudhary (Analytical Chemist) for spending their

valuable time with us in discussing the aspects of industry and providing information for

completion of report.

I also thankful to Mr. Anar Singh (Head Operator) and Skilled Labour of the

Swiss Medicare Pvt. Ltd. specially Mr. Naveen for giving me special knowledge for

handling the blister packaging machine, strip packaging machine, F.B.D., Multimill,

Mass Mixer, Sifter Machine, and Tablet Compression Machine.

I wish to express my gratitude to Mr. Rajesh Dholpuria for providing necessary

help to carry out this report.

I wish to express my gratitude to Mr. Deepak Seervi and Narendra Kumar Nyola

for providing necessary help to carry out this report.

My sincere thanks are also due to staff of library for necessary help rendered by

them.

Last but not least I would like to thanks my friends and classmates for their

valuable assistance during the period of the work.

PUNEET SHARMA