WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3
(2003; 24 pages)


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/ora registration or notification system of suppliers, including traders, brokers and distributors.A variety of WHO guidelines ready for use and inclusion into national legislation are available. Their implementation will be crucial throughout the process towards ensuring the availability and use of quality pharmaceutical starting materials in the manufacture of medicines.

Where a licensing system already exists, inspections should be performed by persons from the competent national or regional statutory authority to assess compliance with good trade and distribution practices (GTDP). Where a notification or registration system is to be implemented, voluntary inspections may be performed before certification for compliance with GTDP.

The use of the new certification scheme is based on the existence of a quality assurance system for the production of starting materials. All parties involved in the trade and distribution of pharmaceutical starting materials are strongly encouraged to comply with the GTDP. Manufacturers of pharmaceutical products should encourage and assist their suppliers to use good storage practice (GSP), GTDP and the relevant parts of good manufacturing practice (GMP).

Trade associations are also encouraged to incorporate these principles into their own codes of practice to be followed by their members.

Another recommendation is the development of a global database listing information on suppliers (e.g. names and addresses) to enable customers to verify supplier information. A global database could later be established to assist in the attempt to address the problem of counterfeiting of pharmaceutical materials.

Training workshops and conferences on GTDP should be planned to promote these principles.

The establishment of model certificates for GSP and GTDP should be envisaged.

National legislation should ensure that penalties can be enforced when persons or suppliers are found to be in violation of legislation. An alert system should be established by the competent authority to prevent trade in non-conforming materials that could put patients at risk. WHO should be informed of such instances so that this information can be made available to other national or regional authorities for action as necessary.

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