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CURRENT GOOD MANUFACTURING PRACTICES AS PER WHO

V.DILIPKUMARROLLNO:06712886027

M.PHARMACY 2nd SEMISTERDEPARTMENT OF PHARMACEUTICS

TRINITY COLLEGE OF PHARMACEUTICAL SCIENCES

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CONTENTS • Introduction• Activities of cGMP• Personnel• Surroundings ,Building and Facilities• Equipment• Material management• Quality management• Manufacturing operation control• Pharmaceutical validation• Sterile Pharmaceutical products• Site plant security• Documentation and records• Conclusion • References

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INTRODUCTION

• cGMP is defined as “it is a part of quality assurance which ensures that products

are consistently produced and controlled to the quality standards appropriate for

their intended use and the legal requirements”

• cGMP is thus concerned with both production and quality control matters.

• cGMP provides complete guidelines on designing material and product

specifications, testing methods and reproducing methods for same.

• The drug regulatory authorities all over world e.g. WHO, M.H.RA.

(U.K),T.G.A(Australia),M.C.C(South Africa),U.S.F.D.A etc. Provides guidelines

based on their requirements.

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ACTIVITIES OF cGMP

• cGMP expects that all the people should be trained.

• It provides complete guidelines on requirements of facilities and equipments.

• cGMP talks about how you should control the quality of materials at every stage.

• It also further talks about quality , production systems and their control.

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PERSONNEL

• The manufacturer should have an adequate number of personal with the

necessary qualification and practical experience.

• Academic qualification required in various areas of specialization

▫ Production: B.Pharm ; M.Pharm; Ph.D.

▫ Q.C/Q.A: B.Pharm ; M.Pharm , M.S.C

▫ Stores: P.G. in material management

▫ Finance :M.com, M.B.A, Chartered accountants

• People in an origination are the main resource and as more value and

importance than other resources like facilities ,equipment and materials.

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• A trained person generally has the knowledge, skill and attitude relevant to

their job and that too in the appropriate levels.

• Training improves human performance on job, working capacity.

• Smoking ,drinking, chewing, food drinking material should not be

permitted into manufacturing, production areas

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SURROUNDINGS,BUILDING AND FACILITIES

• Premises must be located, designed, constructed, adapted ,maintained to suit the

operation to be carried out.

• Premise should be designed and equipment maximum protection against the entry

of insects or other animals

• Washing and toilet facilities should be provided for each individuals in working

areas, cupboards must be provided in change rooms for keeping cloths, other

belongings.

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• Rest and refreshment rooms should be separate from other areas, animal

houses should be well-isolated from other areas, with separate entrance .

• Storage area should sufficient capacity to allow orderly storage of the various

types of materials and products,

• Temperature and humidity conditions should be maintained in storage areas,

• Production area adequate space to prevent cross contamination, area should be

effectively ventilated with air control facilities.

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EQUIPMENT

1. Equipment design, size, and location.

2. Equipment construction.

3. Equipment cleaning and maintenance.

4. Balances and other measuring equipment

shall be calibrated and checked

on periodical basis in accordance

with the SOP’s and records

maintained

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MATERIAL MANAGEMENT

• Stored properly and records maintained as per schedule U .

• All incoming raw material shall be quarantined immediately after receipt or

processing.

• Stored in such a manner that FIRST IN FIRST OUT principle.

• Purchased from approved sources under valid purchase voucher stored

appropriately with labels.

• Authorized staff shall be appointed by license in raw material department

he/she may be from QC department.

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• If any product failed established specification or other relevant qualities

should be rejected

• Reagents made up in the laboratory should be prepared according to

written procedure and appropriately labeled. the label should indicate the

concentration, standardization factor, shelf life.

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Quality management

• The word “QUALITY” has its origin in a Latin word “Qualitas” means

“general excellence.”

• “quality should be built into the product, and testing alone cannot be relied

onto ensure product quality.”

• Each and every manufacturing unit should have its own QC laboratory

with qualified and experienced staff.

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• It is concerned with sampling, specification, testing, documentation and

release procedures.

• S.O.P are maintained for each and every step in the process.

• Each specification for raw

materials, intermediates, final

product ,packing materials shall

be approved and maintained by

Q.C department.

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• Should be independent of the production areas and divided in to separate sections.

• Physico-chemical

• Biological

• Microbiological

• And radio-isotope analysis

• Space shall be provided for

test samples, retained samples , reference standard.

• Suitable to construction materials and ventilation.

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Manufacturing Operational Control

• The main objective of the manufacturing is to produce a quality

pharmaceutical product

• Production operation should follow manufacturing and marketing

authorization

• Simultaneous operations should not performed in the same room to

prevent cross contamination.

• Cleaning, sanitation and disinfection of manufacturing premises falls under

the category of achieving purity in the finished pharmaceutical by avoiding

contamination.

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Pharmaceutical validation

• “It is the documented evidence which provide a high degree of assurance

that a specific process will consistently produce, a product meeting its pre

--determined specifications and quality attributes” .

• Components of a production process such as facilities and equipment must

be validated before use.

• In pharmaceutical industry cleaning validation of facility , equipment and

apparatus is also considered.

• inspection of equipment for cleanliness immediately before use.

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Sterile pharmaceutical products

• Sterile pharmaceutical products are very critical and sensitive products. these

products are free from living organisms , pyrogens and particulate matter.

• The production of sterile preparations should be carried out in clean area .

• The entry of personal and goods into sterile preparation rooms should be

through air lock systems.

• Only the minimum number of

Persons should be present in

Clean area .

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Site and plant security

• Site and plant security is an essential part of the pharmaceutical

manufacturing operations.

• This is mainly related to see that unauthorized persons are not entering in

the plant, which may results into adulteration of product.

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DOCUMENTATION AND RECORDS

• A document is any written ,printed or computer generated information that

is going to provide some evidence. The method of making a document is

called as a documentation.

• It is part of QA and play an imp role in implementation of GMP.

• Documents shall specify the title ,nature and purpose and arranged in such

a manner that it should be easy to check.

• There should be a separate record

book shall be maintained for each

batch and should include

product name, batch no, size, etc.

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CONCLUSION

• Inculcation of cGMP in the organization provides increased

quality of products with less wastage , more profit and

customer satisfaction.

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REFERENCES

P.P Sharma, How to Practice GMPs., 3rd Edition.,2001,206-275.

FDA “Guidance for Industry: Q7A Good Manufacturing Practice

Guidance for Active Pharmaceutical Ingredients,” Section 19.

ICH Q7 Good Manufacturing Practice Guide For Active

Pharmaceutical Ingredients. Current step 4 version; November 2000

Website. Available from: http://www.ich.org/LOB/media/MEDIA433.pdf

[Last cited on 2010 Jan 1]

Manohar A Potdar., cGMP for Pharmaceuticals., Pgno:1-259, 339-382.

FDA “Laboratory Inspection Guide.”

FDA “Inspection Guide for Bulk Drug Substances.”

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Try not to become a man of success but a man of value

Thank you

-Albert Einstein