- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Palabras clave > inspection of pharmaceutical products - standard operating procedures
- Palabras clave > pharmaceutical inspection
- Palabras clave > Quality Assurance of Pharmaceuticals
- Palabras clave > quality control - lot testing
- Palabras clave > sampling and testing - medicines
- Palabras clave > sampling procedure - pharmaceuticals
- Palabras clave > testing - analysis of medicines and active pharmaceutical ingredients
(2005; 35 pages)
These guidelines are primarily intended for use by governmental organizations, such as drug regulatory authorities (including inspectorates), quality control laboratories and customs and police officials, but some of the general principles may also be appropriate for application by procurement agencies, manufacturers and customers.
These guidelines should be useful when surveying the national markets for the quality of drug products in accordance with national drug quality surveillance programmes for marketed products, whether registered for sale or compounded in pharmacies.
The choice of a sampling plan should always take into consideration the specific objectives of the sampling and the risks and consequences associated with inherent decision errors. The bibliography at the end of this Annex should be consulted when justifying a sampling plan for a given purpose.