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

1. Provisions and objectives

1.1 A comprehensive system of quality assurance must be founded on a reliable system of licensing2 and independent analysis of the finished product, as well as on an assurance obtained through independent inspection that all manufacturing operations are carried out in conformity with accepted norms referred to as “good manufacturing practices” (GMP).

2 Throughout this document licensing refers to any statutory system of approval required at national level as a precondition for placing a pharmaceutical product on the market.

1.2 In 1969, the Twenty-second World Health Assembly, by resolution WHA22.50, endorsed requirements for “Good practices in the manufacture and quality control of drugs”(1) (referred to henceforth as “GMP as recommended by WHO”). These comprise internationally recognized and respected standards that all Member States are urged to adopt and to apply. These requirements have since been revised twice. The first revision was adopted by the Health Assembly in 1975 in resolution WHA28.65 (2), and a second revision of the requirements is included in the thirty-second report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (3).

1.3 These standards are fully consonant with those operative within the countries participating in the Convention for the Mutual Recognition of Inspection in Respect of the Manufacture of Pharmaceutical Products, and other major industrialized countries. They also provide the basis for the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (referred to henceforth as “the Scheme”) recommended initially in resolution WHA22.50 (1). The Scheme is an administrative instrument that requires each participating Member State, upon application by a commercially interested party, to attest to the competent authority of another participating Member State that:

- a specific product is authorized to be placed on the market within its jurisdiction or, if it is not thus authorized, the reason why that authorization has not been accorded;

- the plant in which it is produced is subject to inspections at suitable intervals to establish that the manufacturer conforms to GMP as recommended by WHO; and

- all submitted product information, including labelling, is currently authorized in the certifying country.

1.4 The Scheme, as subsequently amended in 1975 (2) and 1988 (4) by resolutions WHA28.65 and WHA41.18, is applicable to finished dosage forms of pharmaceutical products intended for administration to human beings or to food-producing animals.

1.5 Provision for the certification of active ingredients is also included within the scope of the Scheme. This will be the subject of separate guidelines and certificates.

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