1.1 A comprehensive system of quality assurance must be founded on a reliable system of licensing¹ and independent analysis of the finished product, as well as upon assurance obtained through independent inspection that all manufacturing operations are carried out in conformity with accepted norms, referred to as “good manufacturing practices” (GMP).

¹ 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). A second revision of the requirements is included in the Thirty-second report of the WHO Expert Committee on Specifications for Pharmaceutical Products (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 certification of active ingredients is also included within the scope of the Scheme. This will be the subject of separate guidelines and certificates.