- Palabras clave > analysis of drug samples
- Palabras clave > drug testing
- Palabras clave > laboratory quality of medicines
- Palabras clave > quality assurance
- Palabras clave > quality control
- Palabras clave > quality control - lot testing
- Palabras clave > sampling procedure - pharmaceuticals
- Palabras clave > tests, methods, and general requirements
(2002; 4 pages)
Many WHO Member States do not have adequate drug quality control facilities of their own. For drugs imported into such countries, manufacturers’ batch certificates issued in accordance with the WHO Certification Scheme will normally provide sufficient information on the quality and origin of a product. This assumes that an official inspection of the manufacturing site has been performed and that the manufacturer complies with good manufacturing practices. For domestically manufactured pharmaceuticals, manufacturers’ batch certificates may be relied upon to indicate the quality of a product. This implies that the results of an inspection by the competent national authority have shown that the manufacturer is capable of reliably producing a product of the required quality.
However, in certain situations a need may arise for national authorities to test drug samples when testing facilities are not available. For this purpose, laboratories in other countries or contract laboratories in the same or in another country may be contacted (for a model certificate of analysis, see Annex 10). General considerations before approaching them are set out below.