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WHO GMP Certification Scheme M. Mitra Former Dy. Drugs Controller (I), CDSCO, HQ, New Delhi. WHO GMP CERTIFICATION. Originally promugulated in 1969 and revised in 1975. Main objectives were : Guidelines be developed for official inspections of dug manufacturing facilities

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WHO GMP Certification Scheme

M. Mitra

Former Dy. Drugs Controller (I),

CDSCO, HQ, New Delhi


Who gmp certification
WHO GMP CERTIFICATION

Originally promugulated in 1969 and revised in 1975. Main objectives were :

  • Guidelines be developed for official inspections of dug manufacturing facilities

  • To assess compliance of GMP

    This would facilitate implementation of the scheme

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WHO GMP CERTIFICATION

With 191 countries members in the scheme a solution was found for international commerce between these countries. The scheme offered a solution for those countries which did not have a developed regulatory agency yet wanted to import drugs.

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WHO GMP CERTIFICATION

  • Basic principles of WHO Good Manufacturing Practice is similar to any established GMP requirement. Allied documents like Schedule M, CFRs, ASEAN GMP, etc are all similar in nature. Anyone following any established GMP procedure will automatically understand the principles in the other GMP requirements.

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WHO GMP CERTIFICATION

WHO GMP requirements have been developed taking into account the principles in various GMP texts and also considering the requirements of developing countries. These requirements are not for domestic use but for international trade.

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WHO GMP CERTIFICATION

  • There are around 1000 (?) WHO GMP certified manufacturing establishments in the country, with West Zone leading followed by the South, North and the East Zones.

  • New Applications are coming in everyday due to increase in exports of drugs, India being a major exporter of Drugs & Pharmaceuticals Globally.

  • Other purchasers like the State governments, ESI etc. have also started (erroneously) asking for the certificates as preconditions.

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WHO GMP CERTIFICATION

WHO GMP ensures the following:

  • Avoidance of Cross- Contamination

  • Prevention of Mix-ups

  • Provide Traceability

  • Accountability of actions

  • Responsibility

  • Product Performance Guarantee

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WHO GMP CERTIFICATION

Understanding WHO GMP

Documents and Literature

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WHO GMP CERTIFICATION

A series of reports known as the WHO Technical Report Series (TRS) are available.

  • TRS 823 (1992)

  • TRS 834 (1993)

  • TRS 863 (1996)

  • TRS 885 (1999)

  • TRS 902 (2002)

  • TRS 908 (2003)

  • TRS 917 (2004)

  • TRS 929 (2005)

  • TRS 937 (2006)

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WHO GMP CERTIFICATION

Other documents

A WHO Guide to Good Manufacturing Practice (GMP) Requirements (WHO/VSQ/97.02) (for validation)

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WHO GMP CERTIFICATION

Various other documents are available with WHO which is freely available for users. WHO website is the best source for getting information. Similarly documents of other established Regulatory agencies can expand knowledge and understanding

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WHO GMP CERTIFICATION

Issue of Certificates

What are the Certificates?

Three types of Certificates are recommended by the WHO.

These are:

  • Product Certificate(COPP) (TRS 823, 863)

  • Statement of Licensing Status (TRS 823, 863)

  • Batch Certificate (TRS 823, 863)

    There is another Certificate – Site Certificate. Described later

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WHO GMP CERTIFICATION

The member state shall attest the following conditions of a manufacturer if required to attest a product for the certification:

  • A specific product is authorized to be placed in the market of the exporting country, if not why not

  • The manufacturing plant is subject to regular inspections for WHO GMP compliance

  • All product information, including labeling is currently authorized in the certifying country.

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WHO GMP CERTIFICATION

Conditions to be satisfied before opting for the scheme by any member country

  • Effective national licensing system for products, manufacturers and distributor

  • Effective control of quality of products, including independent laboratory

  • A technically competent, experienced, resourceful National Pharmaceutical inspectorate, as part of NDRA having legal powers for investigations

  • Administrative capacity to issue Certificates and quickly notify WHO and other member countries

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WHO GMP CERTIFICATION

Understanding the Technical Report Series

  • TRS 823 – Salient features

    PART I Quality Management in the Drug Industry – Philosophy & Essential Elements

  • Quality Assurance

  • Good Manufacturing Practice

  • Quality Control

  • Sanitation & Hygiene

  • Validation

  • Complaints

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WHO GMP CERTIFICATION

PART I contd.

  • Product recalls

  • Contract Production & Analysis

  • Self-inspection and quality audits

  • Personnel (including key personnel)

  • Equipment

  • Premises

  • Material

  • Documentation

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WHO GMP CERTIFICATION

  • PART II : Good Practices – Production & Quality Control

  • Good Practices in Production

  • Includes General requirements, prevention of cross contamination and bacterial contamination, processing operations, packaging operations

  • Good Practices in Quality Control

  • Control of starting material and intermediate, bulk, and finished products, test requirements, production record review, stability studies

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WHO GMP CERTIFICATION

  • PART III: Supporting and Supplementary Guidelines

  • Sterile pharmaceutical Products

  • General requirements (air classifications), manufacture of sterile preps, personnel, premises, equipment, sanitation, processing, sterilization, filtration, finishing, quality control,

  • Good Manufacturing Practice for Active Pharmaceutical Ingredients

  • Explanation, general considerations, personnel, premises, equipment, sanitation, documentation, retention of records and ref samples, production,

  • Form and content of inspector’s report

  • Validation of analytical procedures

    A Model Certificate Format is also presented

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WHO GMP CERTIFICATION

  • TRS 863 – Salient features

    Useful guidelines:

  • Guidelines for Stability Testing

  • Guidelines for Validation

  • Import Procedure for Drugs

  • Guidelines for implementation of the Scheme (including model certificate)

  • Guidelines on import procedures for pharmaceutical products

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WHO GMP CERTIFICATION

  • TRS 885 – Salient features

    GMP – Authorised Persons - Role, Functions & Training

    Role and position of authorized person, implementation of the quality system, education and training., routine duties of an authorized person,

  • GMP – Supplementary Guidelines for the Manufacture of Pharmaceutical Excepient

    General considerations, self inspection and quality audits, use of equipment, cleaning programme, starting material, rejected and recovered materials, returned excepients, storage practices, specifications, BPRs, change control and process validation, prevention of cross contamination, blending, microbial contamination, water systems, packaging, quality control etc.

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WHO GMP CERTIFICATION

  • TRS 902 – Salient features

  • Good Practices for National Control Laboratories

  • Basic elements of GMP (definition)

  • GMP for Sterile Products – revision

  • Inspections

  • National GMP Inspectorate

  • Guidelines on Packaging of Pharmaceutical Products

  • Storage areas

  • Labels

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WHO GMP CERTIFICATION

  • TRS 908 – Salient features

  • GMP for radio pharmaceuticals

  • GMP for Pharmaceutical Products

    • Main principles

  • HACCP

  • Guidance on GMP: Inspection report

  • Guide to good storage practices for pharmaceuticals

  • Model Certificate of a Pharmaceutical Product

    • Site Certificate – does not replace the Product certificate

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WHO GMP CERTIFICATION

  • TRS 917 – Salient features

  • Active Pharmaceutical Ingredients API

  • Herbal

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TRS 929 – Salient features

  • Concept of sampling of starting materials

  • Heating ventilation and air conditioning

  • Validation

  • Water for pharmaceutical use

    ..\GMP matters\WHO_TRS_929.pdf

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TRS 937 – Salient features

One of the most important TRS

  • Supplementary guidelines on GMP for HVAC

  • (Supplementary guidelines on GMP for Herbals)

  • Supplementary guidelines on GMP : Validation

    • HVAC Water Systems

    • Cleaning

    • Analytical Method

    • Computerized Systems

    • Qualification of systems and equipment

    • Non-sterile process validation

  • Good Distribution Practices for pharmaceutical products

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WHO GMP CERTIFICATION

  • How to Certify a Product

    Certification of products are done after thorough examination of the product and the facilities where these are manufactured

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WHO GMP CERTIFICATION

  • How to Certify a Product

  • The facilities are Inspected NRA Inspectors with good knowledge of GMP

  • The inspection may take two or more days

  • Certificates are issued by the Issuing Authority on the recommendation of the joint report

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WHO GMP CERTIFICATION

  • Requirements

    • Procedures Main Requirements

    • Product

    • Procedures

    • Facilities

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WHO GMP CERTIFICATION

  • Requirements

  • Product

    The basic requirements of the product are:

  • Product design

  • Stability Studies

  • Process validation

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WHO GMP CERTIFICATION

  • Requirements

  • Procedures

    All actions taken in the facility which leads to the production of the final product as per specification.

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WHO GMP CERTIFICATION

  • Requirements

  • Facilities

    This encompasses the building, machinery, services and utilities, manpower etc. These are guided towards making a properly designed product.

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WHO GMP CERTIFICATION

  • Inspection Points

    1. Quality Management

    2. Sanitation and hygiene

    3. Validation

    4. Complaints and recalls

    5. Contract production and analysis

    6. Self Inspection

    7. Personnel

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WHO GMP CERTIFICATION

Discussions:

8. Premises

9. Equipment

10. Materials

11. Documentation

12. Sterile production

13. Active pharmaceutical ingredients

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WHO GMP CERTIFICATION

  • GMP consists of various activities which an be grouped together as follows:

  • Training - induction, ongoing, refresher etc.alonwith such documents like SOP, training calendar, assessment etc.

  • Cleaning sanitation and hygiene - may also include workers entry procedure, cleaning of the premises etc

  • Validation and calibration - qualification of machinery, equipment etc.

  • Storage - apart from normal ware-housing facilities, this should also address quarantine, procedure Etc.

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WHO GMP CERTIFICATION

  • movement of manpower, material - uni-flow movement, movements control etc.

  • Quality assurance –

  • Quality control

  • Documentation- must include MFR, BPR, SOP Documents control & distribution, cleaning, training, and document regulating and recording other activities

  • Change control –

  • Self inspections and audits

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WHO GMP CERTIFICATION

  • Usual Problems faced by Regulatory Agencies:

  • Fund problems

  • Lack of knowledge on the part of applicants

  • Lethargic mindset

  • Back to original condition after Certification

  • Usual Problems faced by applicants:

  • Sometimes lack of Knowledge on the part of auditors

  • Teacher as well as Examiner status

  • Lack of time for thorough auditing

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WHO GMP CERTIFICATION

  • Useful Web Sites:

  • http://www.who.int/en/

  • http://www.who.int/bookorders/anglais/

  • subscription1.jsp?sesslan=1

  • http://www.who.int/medicines/organization/

  • qsm/activities/qualityassurance/gmp/gmpcover.html

  • http://www.fda.gov/

  • http://www.health.gov.au/tga/docs/html/gmphome.htm

  • http://www.mca.gov.uk/

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WHO GMP CERTIFICATION

M. Mitra

Former Dy. Drugs Controller (India),

CDSCO

(M) 9716755102

Email : [email protected]

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Thank you

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