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

2. Eligibility for participation

2.1 Any Member State intending to participate in the Scheme may do so by notifying the Director-General of WHO, in writing, of:

- its willingness to participate in the Scheme;

- any significant reservations it intends to observe relating to this participation; and

- the name and address of its national drug authority or other competent authority.

2.2 These notifications are subsequently announced in the monthly WHO pharmaceuticals newsletter. An updated consolidated list will be published annually in the newsletter and will be available to governments at other times from the Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland. (See also section 3.3.)

2.3 A Member State may opt to participate solely to control the import of pharmaceutical products and active substances. This intention should be stated explicitly in its notification to WHO.

2.4 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, not only for pharmaceutical products, but also for the responsible manufacturers and distributors.

• GMP requirements, consonant with those recommended by WHO, to which all manufacturers of finished pharmaceutical products are required to conform.

• Effective controls to monitor the quality of pharmaceutical products registered or manufactured within the country, including access to an independent quality control laboratory.

• A national pharmaceuticals inspectorate, operating as an arm of the national drug regulatory authority, and having the technical competence, experience and resources to assess whether GMP and other controls are being effectively implemented, and the legal power to conduct appropriate investigations to ensure that manufacturers conform to these requirements by, for example, examining premises and records and taking samples.

• The administrative capacity to issue the required certificates, to institute inquiries in the case of complaint, and to notify expeditiously both WHO and the competent authority in any Member State known to have imported a specific product that is subsequently associated with a potentially serious quality defect or other hazard.

2.5 Each Member State assumes the responsibility to determine, through a process of self-evaluation, whether it satisfies these prerequisites. The Scheme contains no provision for external inspection or assessment under any circumstances, either of a competent national authority or of a manufacturing facility. However, should a Member State so wish, it can approach WHO, or a well recognized drug regulatory authority, occasionally to delegate consultants to act as advisers in the course of both national inspections and inspector training activities.

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