WHO TRS (Technical Report Series) 917 Annex 3

WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation

Preamble:

The quality of pharmaceuticals has been a concern of WHO since its inception. Owing to the nature of these products, this concern includes the quality of the starting materials, i.e. active pharmaceutical ingredients (APIs) and excipients, used for the production of pharmaceuticals.

This guidance text, in combination with other recommendations and guidelines issued by WHO, will be an important step towards ensuring the quality and traceability of pharmaceutical starting materials and in assigning the responsibility for specifications within the processes of manufacture, storage and distribution of pharmaceutical starting materials.

Member States are urged to establish and maintain a legal framework and regulatory approach to ensure that good practices for the trade and distribution of pharmaceutical starting materials are followed. Member States can establish appropriate regulatory control by implementing one or both of the following approaches:

— licensing of suppliers, including traders, brokers and distributors; and/or

— a registration or notification system of suppliers, including traders, brokers and distributors.

See below PDF for complete details:

WHO TRS (Technical Report Series) 917 Annex 3: