MPHARM SEMINAR

SIKSHA‘O’ANUSANDHAN UNIVERSITY BHUBANESWAR

PRESENTED BY – GAYATREE UTTARKABATM PHARM

1st SEMESTERDATE-21/09/2013

SUB – DRA AND IPRTOPIC – WHO CERTIFICATION

SCHEME MOVING IN INTERNATIONAL TRADE

WHO CERTIFICATION SCHEME

INTRODUCTION HISTORY OBJECTIVES ELIGIBILITY FOR PARTICIPATION TYPES OF WHO CERTIFICATE ISSUING A CERTIFICATE ADVANTAGES OF THE SCHEME

INTRODUCTION

An International voluntary agreement to provide assurance to countries participating in the scheme about the quality of the pharmaceutical products moving in international commerce.

It is intended to give assurance to countries that are importing pharmaceutical products but have no national capacity to assess the safety ,efficacy and the quality of the drugs they import.

It is an information exchange mechanism on the quality of imported drugs.

HISTORY

In1969, the World Health Assembly(WHA) by the resolution WHA22.50 endorsed requirements for “Good practices in the manufacture and quality control of drugs. This scheme provide a regular publication of

a list of certified manufacturers. provide batch certificate from drug

regulatory authorities of exporting country. In 1975, in resolution WHA28.26 the

scheme was revised

In 1988, the 1975 version was expanded to include Veterinary products administered to food

producing animals Finished pharmaceutical products for

human use Information on safety and efficacy

In 1992 the WHA proposed a revised version of the scheme in resolution WHA45.29

In 1997 , the current version was adopted.

OBJECTIVE

A comprehensive system of quality assurance should be established on a reliable system of licensing/registration.

An independent analysis of finished product

An assurance should be obtained through independent inspection that all manufacturing operations are carried out in conformity with GMP

ELIGIBILITY FOR PARTICIPATIONAny member state which intends to

participate in the scheme should write to the Director general of WHO

its willingness to participate in the scheme. Any significant reservations it intends to

observe relating to this participation. The name and address of its national drug

authority or other competent authorityThese notification are announced in the

monthly WHO pharmaceuticals newsletter.

A member state which intends to make use of this scheme to support the export of the pharmaceutical products should first satisfy the following

Existence of an effective licensing system for manufacturer of products. cGMP regulation must be followedBy the DI, his checking report for all the plant or product should be revised.In case of any complain during inquiries then it should be notify quickly to both WHO and competent authority.

TYPES OF WHO CERTIFICATE

There are three types of certificates are issued under the current scheme

A certificate of a Pharmaceutical Product (COPP)

A batch certificate of a Pharmaceutical Product

A statement of licensing status of Pharmaceutical Product(s)

CERTIFICATE OF A PHARMACEUTICAL PRODUCT

In India certificate for pharmaceutical product under WHO certification scheme is issued by the state licensing authorities in coordination with the staff of Central Drug Standard Control Organisation (CDSCO).

It states whether or not the product is marketed in the country of origin.

States that manufacturer of product complies with GMP and that they are inspected regularly by the competent authority.

BATCH CERTIFICATE

A batch certificate of a pharmaceutical product refers to an individual batch of a pharmaceutical product and is a vital instrument in drug procurement.

A batch certificate is normally issued by the manufacturer . But in case of sera, vaccines and some biological products it may be issued by competent authority of the exporting country.

STATEMENT OF LICENSING STATUS

This certificate certifies only that a licence has been issued for a specified product, or products for use in the exporting country.

It is intended for use by importing agents when considering bids made in response to an international tender.

ISSUING A CERTIFICATE

The certifying authority is responsible for assuring the authenticity of the certified data.

Certificates should not bear the WHO emblem, but a statement should always be included to confirm whether or not the document is issued in the format recommended by WHO.

ADVANTAGES OF THE SCHEME It uses standard format It can enable importing countries

to get all the information they need to know about the product they import

It can enhance the exchange of information between countries.

REFERENCES

Quality assurance of pharmaceuticals, a compendium and related materials, World Health Organisation Geneva, A.I.T.B.S. Publishers India, volume-1, page no-187-194

How to practice GMPs ,5th edition , P.P. Sharma Published by Vandana publications pvt. Ltd. Delhi

WHO Certification Scheme for finished pharmaceutical products ; by Margareth Nodomondo-Sigonda, Director general Tranzania Food and Drugs Authority(TFDA),13th ICDRA,16-19 September 2008, Switzerland

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