An Industrial Tour Report 2010

PARK – BENZ LABORATORIES

(Plot no. 92 new industrial area mandideep dist. Raisen, M.P.)

Submitted by

SHEKHAR NAMDEV

0193PY071048

B.Pharmacy 4th year(VIII SEM)

Batch 2007

Sagar Institute of Research Technology &

Science Pharmacy, Bhopal

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PARK BENZ LABORATORIES

(Plot no. 92 new industrial area mandideep dist.-Raisen, M.P.)

CERTIFICATION OF VOCATIONAL TRAINING

This is to certified that Mr. MAYANK SAHU student of sagar institute of research technology & science – Pharmacy, Bhopal has undergone vocational training in our organization in partial Fulfillment of academic requirement from 21-06-2010 to 18-07-2010.

During this period, we found him sincere and hard working.

We wish his success in his career.

Date____/____/_____ Mr. R.K. KATHAL

Place – Mandideep (Raisen) Plant Manager

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ACKNOWLEDGEMENT

I take this opportunity to place on record my grateful thanks and sincere gratitude to my principal Dr. R.V.GOSWAMI who gave me valuable advice and input for my training.

I am immensely grateful to my guide Mr. R.K. KATHAL (Plant Manager), whose continued and invaluable guidance con never be forgotten by me for whom, this study could not have got present shape.

Last but not least, I would like to express my thanks to my friend and family member who inspired me to put best effort for the training report.

Mayank Sahu

B. Pharm 4th year (VIII SEM)

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G M P GUIDELINE

The term good manufacturing practices mean different things to different

people. There are FDA guidelines describing GMP but even these can

and are interpreted differently by people in the FDA and in industry.

Common sense exercised by people who have a good theoretic

knowledge of pharmaceutical principles, and who are technically

competent and have adequate relevant experience in manufacturing,

guarantees compliance to GMP.

A checklist of GMP items that should be part of scale up or new product

or process introduction include following :-

Equipment qualification

Process validation

Regularly scheduled preventative maintenance.

Regular process review and revalidation.

Relevant written standard operation procedures.

The rise of competent, technically qualified personnel.

Adequate provision for training of personnel.

A well defined technology transfer system.

Validated cleaning procedures.

An order arrangement of equipment so as to ease material flow

and prevent cross contamination.

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PARENTERAL PREPARATION

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CONSIDERATIONS IN DEVELOPMENT OF FORMULAE

VEHICLE

Water for injection is the vehicle of first choice. It should be free from

ions and pygrogens.Water of suitable quality must be prepared by

distillation/reverse osmosis.In addition to water some co-solvents are

sometimes used to replace a portion of water in certain formulations.

ADDITIVES

Parenteral products contain many solute (highest purity) as stabilizers or

additive substances.

a) Stabilizers-

It ensure the stability of drug compound in the preparation. It

prevent oxidation and hydrolysis.

Oxidative degradation can be minimized by the use of anti-

oxidants.

Hydrolytic degradation can be minimized by adjustment of pH.

b) Buffering agents-

Formulations must maintain the intended pH. Change in the pH of

a product may occur during storage because of degradation

reactions taking place in the product.

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c) Anti-Oxidants-

They are needed in the parenteral products containing oxygen

sensitive drug so as to avoid oxidative degradation.

d) Antimicrobial agents-

These agents are to be essentially included in multiple dose

packaging to prevent multiplication of any accidentally introduced

microbes in the products during the withdrawal of doses.

e) Tonicity contributors-

Some parenteral solutions are required to be isotonic with blood

serum or other body fluids.

f) Wetting ,Suspending and emulsifying agents-

Wetting agents are used in injectable suspensions to maintain the

particle size and to counteract caking.

CONTAINERS AND CLOSURES

Any container for parenteral products should maintain the integrity of the

Product as a sterile, pyrogen free, high purity preparation till it is

used.Plastics used in the packing of parenteral products are based on

poly-ethylene. Plastic containers are must less used as compared to

glass but the former are becoming increasingly popular for intravenous

fluids.Rubber is the material of choice for closures for multiple dose

vials.

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FILLING, SEALING AND STERILIZATION OF PARENTERAL PREPARATION:-

AUTOMATED MACHINE FOR PARENTERAL PREPARATION

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BELT CONVEYOR

Belt conveyors, that are designed to suit the severe working conditions.

Featured with long working life, belt conveyors having 300 tons per hour

(TPH). They require less maintenance and one can operate them very

easily

“BELT CONVEYOR”

.

APPLICTION

In Cement, Steel, Sugar, Mining, Construction, Paper & Pulp, Pharma &

Other light & heavy Engineering Industries.

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FLOW DIAGRAM OF PARENTERAL PREPARATION

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EVALUATION OF PARENTERAL PRODUCTS

STERILITY TESTING

Tests for sterility are intended for detecting the presence of aerobic and

anaerobic viable form of bacteria,fungi and yeasts.

Principles of sterility testing-

A suitable amount of the material under test is transferred aseptically

into sterile nutrient media and incubated for suitable period of time at

optimum temperature. After incubation , the media are examine for the

presence or absence of any microbes.

PYROGEN TESTING

These are the metabolic products of living or the dead microbes which

cause are pyretic reaction upon injection. Pyretic injection includes

Malaise, Headache and increased body tempreture.

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CLARITY TESTING

It consists of human visual inspection with the aid of good direct lighting

on the containers with the products against a black and a white

background.

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Area of store

SAMPLING AREA

RM is sampled here by Q.A department, the RM is tested for its Quality,

Quantity and Purity.

DISPENSING AREA-

Dispensing of raw material is done after getting requisition slip from

manufacturing department.

QUARANTINE AREA-

The finished products where sample is sent to quality assurance

department for its final approval, is stored here and this is a restricted

area.

BONDED STORE ROOM-

The finished product approved by Q.A department is ready for dispatch

is stored here.

STORE

All the materials ranging from raw material to packaging materials

and engineering goods to stationery items first accepted at stores, it

is then sent to various departments.

After getting the requisition slip by that department, the raw material

is kept in various racks denoted by specific colures, which indicate

the states of that material.

COLOUR AREA

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Red Rejected area

Green Approved area

Yellow Area of under test

Grey Quarantine

Raw material is then checked by Q.A department, the yellow

colour rack is kept in packaging material, is under test. This is

divided into three parts-

Under testing packing material sampling area.

Sampling containers.

Empty drums

Raw material is packed with polyethylene bags and well labeled. There

is a specific temperature and humidity, which is passed in Q.A

department, in this sampling packing area, is

Container.

Boxes (packing container).

Polyethylene bags.

Many RM

Drums.

This area is also called as approved area.

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FUNCTION OF STORES

1. Receiving the RM/PM (Packing material) from supplier.

2. Dispensing of RM/PM and issuing to a production department

against on ORNL/OPNL.

ORNL = Operation raw material use.

OPNL = Operation packing material use.

3. Sampling of RM/PM received from supplier for sending to Q.A

department for

analysis.

4. Proper storage of RM/PM and the finished product is separate

areas under

proper condition so that stored materials are not degraded.

5. Maintaining proper record of-

RM/PM received by the stores.

The material which have been approved by Q.A.

The raw material, packing material sent to production

department, and those, which have been dispatched.

The finished product coming to store and those which have

been dispatched.

The cost of RM/PM , finished product, cost of transportation,

various duties imposed on finished products etc.

SIGNIFICANCE 18 | P a g e

The department of store plays an important role in management of a

company. This is because the stores is concerned with maintaining the

quality of RM/PM and finished products for long period, especially in

case of those substance which are to be stored very completely,

otherwise which have scarcity of price in market and purchasing is not

possible whenever desired.

QUALITY CONTROL AND QUALITY

ASSURANCE

QUALITY CONTROL

It embodies the carrying out of those plans during production and

includes all of the tests and evaluation performed to be sure that quality

has been achieved in a specific lot of product.

The QC unit should have the responsibility and authority to approve or

reject any procedure or specification, which is likely to affect product

quality. Quality control may not have expertise in all area but it must

have the ability and knowledge to form judgment of the likely impart of

several factor on the quality of the output from the factory.

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QUALITY ASSURANCE

It relates to the studies made and the plans developed for assuring

quality of a productive prospectively.

Every manufacturing establishment shall have a Q.C department

supervised by approved expert staff directly responsible to the

management but independent of other department. The Q.C

department shall control all raw materials, monitor all in-process

quality checks and control the quality and stability of finished

products

Asepsis is to be maintained in this area so each and every person

entering here must wear specially designed gowns. People

entering here must cover their head with cap and cover their feet

with specially designed shoes covers.

Quality control department shall have following principal duties

To prepare detailed instrument, in writing for carrying out each test and analysis.

To release or reject each batch or rawmaterials.

To release or reject semifinished product if necessary.

To release or reject packing and labeling material and the final containers in which drugs are to be packed.

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To release or reject each batch of finished product that is ready for distribution.

To evaluate the quality and stability of finished product.

To establish shelf life and storage, requirement on the basis of stability tests related to storage condition.

To establish and when necessary control procedure and specification.

To examine returned products as to whether such product should be released, reprocessed or destroyed.

Quality Observed

Four types of area are, In which Quality are observed

1. HPLC CHAMBER.

2. CHEMICAL ANALYSIS

3. PHYSICAL ANALYSIS

4. MICROBIOLOGICAL ANALYSIS

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HPLC CHAMBER

MICROBIOLOGICAL ANALYSIS

STORAGE OF DRUGS-

Storage of drugs should be done in proper manner to maintain their

stability. The storage done according to nature of drugs and their

recommended condition.

The drugs to be stored in following type of stability chamber which

maintain temperature and the humidity of surrounding area.

Stability Chamber Temperature Relative humidity

1’st 45’C 75%

2'nd 30’C 65%

3’rd 25'C 35%

4'th 8’C ---

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CONCLUSION

Park - Benz Laboratories has become one of the Indian pharmaceutical

industry steadily increasing its business right from 2007. The industry’s

ability to produce bulk activities in the regulatory controlled facilities has

helped to meet challenges of global environment.

The training in Park-Benz has given the knowledge of actual working of

a pharmaceutical industry. It has also enlightened the processing steps

like safety, quality control, formulation unit and packing etc.. resulting in

pharmaceutical industry.

The training provide to be a golden opportunity for me in allowing me to

understand various operation in a pharmaceutical industry. On exposure

to the industrial staff, I find the industry staff is really hard working,

sincere and of very co-operative nature.

The experience that I have received during my training period will give

me a new horizon in my carrier.

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