Any comprehensive system of quality assurance must be founded on a reliable system of controlling the quality, safety and efficacy of a finished product delivered to a market. It is important that all manufacturing operations are carried out in conformity with the accepted norms of GMP.
The distribution channel and supply chain need to follow quality assurance as well in order that patients are getting quality medicines. WHO has issued a number of international standards assisting Member States and those involved in the supply chain.
- Control and safe trade of starting materials for pharmaceutical products
Good trade and distribution practices for pharmaceutical starting materials
WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
Good distribution practices for pharmaceutical products
- Certification scheme on the quality of pharmaceutical products moving in international commerce
Guidelines on import procedures for pharmaceutical products
Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies
Guidelines on the requalification of prequalified dossiers
Guidelines for the preparation of a procurement agency information file
A model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products)