In March 2005, the EDQM published a summary of information on GMP
inspections initiated or conducted by the EDQM.The EDQM conducts GMP inspections of API manufacturers and traders who
have applied for a Certificate of Suitability (CEP). When handing in the
necessary documents in order to obtain a CEP, the applying manufacturer confirms that the API described in the
CEP is produced in compliance with the GMP rules (ICH Q7A).
These EDQM inspections are conducted independently of the location of
the API manufacturer, i.e. not only in Europe.
The Directives 2004/27 (Human Medicinal Products) and 2004/28
(Veterinary Medicinal Products) dating from 2004 define that manufacturers
of raw materials for pharmaceutical use are not inspected systematically.
Instead, priority classes are identified. On the basis of these
priorities, inspections are conducted at selected companies. The
priorities for the years 2004 and 2005 are as follows:
- Manufacturers of sterile APIs
- Manufacturers for which the CEP assessor recommends an inspection
- Manufacturers of raw materials with TSE risk
- Brokers, traders or other third parties who hold a CEP (instead of
the manufacturer)
If you would like to read more details regarding EDQM inspections, we
recommend you the:
EDQM
Inspection Programme, March 2005
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