EMEA and European Commission Publish Document to Describe the Issue and Update of GMP Certificates

GMP News No. 927: EMEA and European Commission Publish Document to Describe the Issue and Update of GMP Certificates

GMP News
19 April 2007
 

EMEA and European Commission Publish Document to Describe the Issue and Update of GMP Certificates

 
The European Medicines Agency EMEA and EU Commission's DG Enterprise and Industry Directorate have developed a document which describes the issue and update of GMP Certificates. The paper is part of the Compilation of Community Procedures on Inspections and Exchange of Information.

Directive 2001/83/EG amended by Directive 2004/27/EG requires that "within 90 days of an inspection … a certificate of good manufacturing practice shall be issued to a manufacturer if the outcome of the inspection shows that the manufacturer complies with the principles and guidelines of good manufacturing practice as provided for by Community legislation" (article 111 §5).

The document is intended to give interpretation on aspects of responsibilities of the issue, renewal and update of GMP certificates. The issue of GMP certificates following an inspection of a manufacturer of IMPs is not defined, however Member States may choose to do so. In any case an entry in the EudraGMP database should be made whether or not a certificate is issued to the manufacturer in question.

Date of coming into operation is 30 September 2007.

The full document can be found on EMEA's website.
  

Learn more about inspections, audits and related topics at ECA's GMP Education Course:

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
  

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