WHO CERTIFICATION SCHEME

Presentation By: Dr. Sai Krushna Padhy

Professor in Pharmacy

OUTLINE
Introduction Evolution of The Scheme Types Of Certificates Guidelines for Implementation of Who Certification Scheme
Provision and Objectives Eligibility for Participation Requesting a Certificate Issuing a Certificate Notifying and Investigating a Quality Defect

INTRODUCTION

W.H.O. certification scheme is a recommendation for the Regulatory authorities of the WHO member countries to harmonize & make easy the administrative and documentation requirements for Import & Export of Drugs. The actual certificates are issued by the respective National Regulatory Authority in their own formats. In INDIA CDSCO issues the necessary certificates.

The WHO Certification Scheme __________________________________________

An international voluntary agreement to provide assurance -to countries participating in the Scheme about the quality of
pharmaceutical products moving in international Commerce.

A tool developed in response to requests of WHO Member States A voluntary/non binding agreement between WHO Member States An information exchange mechanism on the quality of imported medicines Intended to give assurance to countries that are importing pharmaceutical products but have no national capacity to assess the safety, efficacy and quality of the medicines they import Is intended to facilitate availability and trade in pharmaceuticals by ensuring safety, efficacy and quality

Evolution of the Scheme _________________________________________

In 1963 the World Health Assembly (WHA) passed resolution asking for
examination of ways and means of ensuring that drugs exported from a producing country comply with drug control requirements which apply in that country for domestic use In 1969, the WHA adopted Good Practices in the Manufacture and Quality Control of Drugs -Up-to-date list of manufacturers complying with GMP to be issued by governments -Batch certificate to be issued by health authorities of exporting countries.

In 1975, the Scheme was revised to include the registration status of the product in the exporting country the GMP compliance of the responsible manufacturing unit In 1988, the 1975 version was expanded to include Finished pharmaceutical products for human use Veterinary products administered to food producing animals Product information and labeling In 1992 the WHA proposed a revised version of the Scheme In 1997, after 5 years of testing, the current version was adopted

 Three types of certificates are issued under the current scheme: Certificate of a Pharmaceutical Product (COPP) the primary Doc
-Is used in connection with product registration -Provides information on: the product, GMP status of the manufacturing plant, the certifying authority -Assures that the product information accompanying the certificate is the same as the one approved by the certifying country

The Current Version

Model Batch Certificate of a Pharmaceutical Product Model Statement of Licensing Status of Pharmaceutical Product(s)

Provision and Objectives

To assure that manufacturing operations should comply with GMP The scheme is an administrative mechanism, which requires each participating member state to attest the following to the competent authority of another participating member state
A specific product is authorized to be placed on the market within its jurisdiction The plant in which it is produced is subject to inspection at suitable intervals All submitted information, including labeling, currently authorized in the certifying country.

ELIGIBILITY FOR PARTICIPATION IN THE SCHEME:

Any Member State intending to participate in the Scheme may do so by notifying the Director-General of the WHO, in writing, of: 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 regulatory authority or other competent authority. These notifications will be subsequently announced in the monthly WHO Pharmaceutical Newsletter.

 A Member State intending to use the Scheme to

support the export of pharmaceutical products should first satisfy itself that it possesses: An effective national licensing system, for pharmaceutical products, manufacturers and distributors; Implementation of GMP requirements, recommended by WHO. Effective controls to monitor the quality of pharmaceutical products registered or manufactured within its country,

 Competent inspectorate staff, which can investigate to ensure that manufacturers conform to these requirements; Administrative capacity to issue the required certificates and do inquiries in case of complaint. Each Member State do a process of self-evaluation, to determine, whether it satisfies these prerequisites. There is no provision for external inspection or assessment of a competent national authority or a manufacturing facility .

HOW THE SCHEME OPERATES

Requesting a certificate
3 documents can be requested within the scope of the scheme;
A certificate of a pharmaceutical product, A statement of licensing status of pharmaceutical products, Batch certificate of pharmaceutical products.

Proposed formats are there for these documents in the guideline in App-I, App-II and App-III. All participating countries are encouraged to adopt these formats to facilitate interpretation of certified information.

 A list of addresses of competent national regulatory authorities participating in the scheme, may be obtained from WHO as indicated in the pharmaceutical newsletter.

Each participating country in the scheme should issue guidelines to all agents responsible for importing under its jurisdiction, to explain the contribution of certification to the drug regulatory process and the circumstances in which each of three types of documents will be required.

CERTIFICATE OF A PHARMACEUTICAL PRODUCTS

It is issued by the exporting country , and use by the competent authority within importing country in two situations: When the product in question is under consideration for a product license that will authorize its importation and sale. When administrative action is required to renew, extend, vary, or review such a license. All requests for certificates should be channeled through the agent in the importing country and the product license holder in the exporting country (the applicant)

The applicant should submit the following information for each product:
Brand name, ---name and dosage form Name and the amount of active ingredient per unit dose Generic name (International Non-proprietary Name, where such exists), Name and address of product licence holder and/or manufacturing facility, Formula (When no product license exist or When the formulation differs from that of the licensed product) Product information for medical professionals and for patients as approved in the exporting country,

The certificate can be issued by the competent authority in the exporting country with the permission of the applicant and, if different, of the product-license holder. The certificate is intended to be incorporated into the product-license application in the importing country. Once prepared, applicant or agent in importing country transfer it to the requesting authority. If any doubt arises about the status or validity of a certificate, the competent authority in the importing country should request a copy direct from the certifying authority.

 In the absence of any specific agreement, each certificate will be prepared exclusively in the working languages of the certifying authority and the applicant will be responsible for providing any notarized translation that may be required by the requesting authority. Since the preparation of certificates imposes a significant administrative load on certifying authorities, the service may need to be financed by charges levied upon applicants. Supplementary attestations are obtainable only at the discretion of the certifying authority and with the permission of the applicant. The certifying authority is under no obligation to supply additional information.

Example -certificate for pharmaceutical product No. of certificate Exporting (certifying country): Importing (requesting country): Name and dosage form of the product: Active ingredient and amount per unit dos:

STATEMENT OF LICENSING STATUS

This attests only that a license has been issued for a specified product , or products, for use in the exporting country.
It is used by importing agents when considering bids made in response to an international tender, in which case it should be requested by the agent as a condition of bidding.

The importation of any product that is provisionally selected through this procedure should be determined on the basis of a certificate of a pharmaceutical product.

ExampleNo. of statement: Exporting (certifying) country: Importing (requesting) country: This statement indicates only whether or not the following products are licensed to be put on the market in the exporting country. Applicant (name/address):
Name of product Dosage form Active ingredient and amount per unit dose Product-license No. and date of issue

BATCH CERTIFICATE

This certificate is issued by the manufacturer and only exceptionally in the case of the vaccines, sera, and certain other biological products, by the competent authority of the exporting country.

This is used to accompany and provide an attention concerning the quality and expiry date of a specific batch of product that has already been licensed in the importing country. This should include the specifications of the final product at the time of batch release and the results of the full analysis.

 In most circumstance these certificates are issued by the manufacturer to the importing agent, but they must be made available in the course of any inspection made on behalf of the competent national authority.

Example: 1. No. of Certificate: 2. Importing (requesting) authority: 3. Name of product:

Dosage form: Active ingredient and amount per unit dose: Is the composition of the product identical to that registered in the country of export? If no: please attach formula (including excipients ) of both products.

 4. Product-licence holder(name and address):

Product-licence number: Date of issue: Product licence issued by: Product certificate number:

5.1 Batch number: 5.2 Date of manufacture: 5.3 Shelf life (years): 5.4 Contents of container: 5.5 Nature of primary container: 5.6 Nature of secondary container/wrapping: 5.7 Specific storage conditions: 5.8 Temperature range:

6. Remark: 7. Quality analysis:

7.1 What specifications apply to this dosage form. Either specify the pharmacopoeia or append company specifications. In the case of a product registered in the exporting country, have these company specifications been accepted by the competent authority? (yes/no) 7.2 Does the batch comply with all parts of the above specifications? (yes/no) 7.3 Append certificate of analysis

 It is hereby certified that the above declarations are correct and that the results of the analyses and assays on which they are based will be provided on request to the competent authorities in both the importing and exporting countries. Name and address of authorized person: Telephone no: Fax number: Signature of authorized person: Stamp and date:

ISSUING A CERTIFICATE:
The certifying authority should assure the authenticity of the certified data. Certificate should include the statement to confirm whether or not the document is issued in the format recommended by WHO. When the applicant is the manufacturer of the finished dosage form, the certifying authority should satisfy itself, before attesting compliance with GMP, that the applicant: Applies identical standards to the production of all batches of pharmaceutical products manufactured within the facility, including those intended exclusively for export;

 Consents (in the event of identifications of a quality defect) to relevant inspection reports being released, in confidence, to the competent authority in the country of import, should the latter so require.

When the applicant is not the manufacturer of the finished dosage form, satisfy itself described as above. GMP as recommended by WHO assigns to the manufacturer of the finished dosage form, for assuring the quality of active ingredients be identified in the product license, but the competent authority may have no power to inspect them.

 Certifying authority may be able to attest that the manufacturer is an established supplier of the substance in question to manufacturers of finished dosage form licensed for marketing under its jurisdiction.
Whenever a product is purchased through a broker or another intermediary, the certifying authority should consider that those aspects of the manufacture of the product for which the applicant is not directly responsible have been undertaken in compliance with GMP as recommended by WHO The certifying authority should officially stamp and date all copies of product information submitted to it in support of an application for a certificate. Any additional attachment to a certificate submitted by the applicant, should be clearly identified as not forming part of the attestation made by the certifying authority.

 Each certificate should identify the importing country and be stamped on each page with the official seal of the certifying authority;
To prevent potential misuse of the scheme To provide routine authentication of certificates by an independent authority superfluous, To enable the certifying authority to maintain comprehensive records of countries to which specific products have been exported.

An identical copy, clearly marked as duplicate, should be forward by the certifying authority on demand direct to the authority in the importing country.

NOTIFYING AND INVESTIGATING A QUALITY DEFECT:

Each certifying authority inquire, any quality defect reported in a product exported in accordance with the provision of the scheme, on the understanding that:
The complaint is transmitted, together with the relevant facts, through the competent authority in the importing country; The complaint is considered to be of a serious nature by the latter authority; The defect, if it appeared after delivery of the product in to the importing country, is not attributable to local conditions.

In the case of obvious doubt, a participating national authority may request WHO for independent Q.C laboratory to carry out tests for the purposes of quality control.
Each certifying authority should inform WHO and, as far as possible, all competent national authorities, of any serious hazard newly associated with a product exported under the provisions of the scheme.

Address of certifying authority:

Name of authorized person:

Telephone/fax numbers: Signature: Stamp and date: