Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Close this folder7. International trade in pharmaceuticals
Close this folderGuidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce1
View the document1. Provisions and objectives
View the document2. Eligibility for participation
View the document3. Requesting a certificate
View the document4. Issuing a certificate
View the document5. Notifying and investigating a quality defect
View the documentReferences
View the documentAppendix 1. Model Certificate of a Pharmaceutical Product
View the documentAppendix 2. Model Statement of Licensing Status of Pharmaceutical Product(s)
View the documentAppendix 3. Model Batch Certificate of a Pharmaceutical Product
View the documentAppendix 4. Glossary and index
View the documentWorld Health Assembly resolution WHA50.3: Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the documentGuidelines on import procedures for pharmaceutical products1
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover

4. Issuing a certificate

4.1 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.

4.2 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:

(a) applies identical GMP standards to the production of all batches of pharmaceutical products manufactured within the facility, including those destined exclusively for export;

(b) consents, in the event of identification of a quality defect consonant with the criteria set out in section 5.1, to relevant inspection reports being released, in confidence, to the competent authority in the country of import, should the latter so require.

4.3 When the applicant is not the manufacturer of the finished dosage form, the certifying authority should similarly satisfy itself - in so far as it has authority to inspect the records and relevant activities of the applicant - that it has the applicant’s consent to release relevant reports on the same basis as described in section 4.2 (b) above.

4.4 GMP as recommended by WHO assigns to the manufacturer of the finished dosage form responsibility for assuring the quality of active ingredients. National regulations may require that suppliers of active ingredients be identified in the product licence, but the competent authority may have no power to inspect them.

4.5 Notwithstanding this situation, a certifying authority may agree, on a discretionary and voluntary basis, and at the request of a manufacturer, to undertake an inspection of a manufacturer of active ingredients to satisfy specific requirements of a requesting authority. Alternatively, pending the development of specific guidelines for active pharmaceutical ingredients, the certifying authority may be able to attest that the manufacturer is an established supplier of the substance in question to manufacturers of finished dosage forms licensed for marketing under its jurisdiction.

4.6 Whenever a product is purchased through a broker or another intermediary, or when more than one set of premises has been involved in the manufacture and packaging of a product, the certifying authority should consider whether it has received sufficient information to satisfy itself 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.

4.7 The certifying authority should officially stamp and date all copies of product information submitted to it in support of an application for a certificate and intended to be appended to the certificate. Every effort should be made to ensure that certificates and all annexed documentation are consonant with the version of the product licence operative on the date of issue. When available, the certifying authority will add a summary basis of approval or any other material that it may deem relevant. Translation by an applicant of these materials into a widely used language, preferably English, shall be deemed to satisfy the provisions of section 3.10.

4.8 Any additional attachment to a certificate submitted by the applicant, such as price lists of products for which bids are offered, should be clearly identified as not forming part of the attestation made by the certifying authority.

4.9 To avert potential abuse of the Scheme, to frustrate attempts at falsification, to render routine authentication of certificates by an independent authority superfluous, and to enable the certifying authority to maintain comprehensive records of countries to which specific products have been exported, each certificate should identify the importing country and be stamped on each page with the official seal of the certifying authority. If requested by the importing country, an identical copy, clearly marked as duplicate, should be forwarded by the certifying authority directly to that country’s authority.

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