EU Publishes the New EU Directive 2004/27 - Consequences for the GMP-regulated Environment

GMP News No. 417

GMP News
5 May 2004
 

EU Publishes the New EU Directive 2004/27 -
Consequences for the GMP-regulated
Environment

 
We had already announced the long-awaited Directive in our GMP News of 31 March 2004. At that time, the Directive had not yet been published officially. This has now been done on 3 May (together with several translated versions). As we had said, the Directive is made retrospective to 31 March 2004. In the following we will repeat the most important changes for the GMP-regulated environment: 

The suggestions for change mainly concern finished medicinal products (the topics are marketing authorisation, clinical trials, pharmacovigilance). However, some of the amendments are also relevant to API manufacturers and can be summarised like this:

  • Manufacturers of medicinal products may only use APIs that have been manufactured according to the GMP principles
  • The competent supervisory authority can conduct inspections at the premises of API manufacturers if there is reason to doubt their GMP compliance
  • The European Pharmacopoeia Commission may ask the EU Commission or the European authority EMEA to request an inspection if the starting material is the subject of an API monograph
  • In case an inspection at the premises of an API manufacturer leads to the detection of non-compliance, the information is recorded in a Community database

Even though this Directive requires API manufacturers to comply with the GMP principles, the supervisory authorities do not have to conduct inspections, as in the case of medicinal products. (The English original says: "The competent authority may carry out inspections..." and not "...must...") So there is no legal basis for a national operation ordinance for API manufacturers either.

On the other hand, there is increasing pressure on the API manufacturers to follow the GMP principles because the pharmaceutical companies will have to enforce this requirement against their API suppliers.

Pharmaceutical API companies will thus be forced to comply with the principles of Annex 18 to the EU GMP Guide (ICH Q7A "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients") in the manufacture of their APIs if they want to stay in business.
  

On the topic of GMP-compliant API manufacture, the European Compliance Academy is organising the following events:

 
Author
:
Dr Gerhard Becker
CONCEPT HEIDELBERG

Sources:

 

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