EDQM's Inspection Programme

EDQM's Inspection Programme

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
 

How can you prepare yourself for an inspection? What should you do during an inspection? These key questions are the focus of the ECA event: 

• How to Pass EU and FDA Inspections - GMP Compliance Auditor Course
  Prague, 16-18 November 2005