EMA's Inspectors Working Group Publishes Work Plan 2010
At the beginning of this year, the European Medicines Agency (EMA) published the work plan for the GMP/GDP (Good Manufacturing Practice/ Good Distribution Practice) Inspectors Working Group. The document gives a good overview of the changes to be expected for the GMP/GDP environment - and they might be legion. A separate chapter deals with GMP/GDP aspects, assigning priorities. In the following you can read the details.
The revision of the EC GMP Guide is a high-priority task:
Chapters 1 (Quality Management) and 2 (Personnel): inclusion of ICH Q10 elements
Chapter 3 (Premises and Equipment): changes regarding "dedicated and self-contained facilities" (in synchronisation with the FDA)
Chapter 5 (Production): integration of the requirement to use active pharmaceutical ingredients manufactured in compliance with the GMP rules and to clarify requirements on analytical tests for raw materials
Chapter 7 (Contract Manufacture and Analysis): greater emphasis on the topic of outsourcing
Chapter 8 (Complaints and Product Recall): better integration of the subject "quality defects" and of quality risk management elements with regard to these chapters
An equally high priority has been assigned to the revision of various annexes to the EC GMP Guide:
Annex 2 (Manufacture of biologics): a second public consultation paper is being announced as well as plans for a meeting with the parties interested in this topic
Annex 11 (Computerised Systems): Publication of the final document in parallel with the changes to Chapter 4 (Documentation) of the EC GMP Guide
Annex 14 (Manufacture of Medicinal Products Derived from Human Blood or Plasma): the final text is meant to be synchronised with the European Commission with regard to the EC Directive 2002/98/EC
Publication of a draft for the revision of the GDP guideline for public consultation. The topic of GDP is also intended to be introduced as a new chapter into the "Compilation of Community Procedures on Inspections and Exchange of Information", so to speak as the operating procedure for European inspectors.
The following subjects are mentioned with low priority:
EC GMP Guide: Chapter 6 (Quality Control): initiation of a revision process in order to identify minimum requirements on the transfer of analytical methods
EC GMP Guide: Annex 15 (Validation): review with regard to adaptations of the revised CHMP guideline on process validation and ICH Q8, Q9, Q10
EC GMP Guide: Annex 17 (Parametric Release): revision in view of the revised CHMP guideline on parametric release with the aim of including Real-Time Release Testing
GMP issues specific to Investigational Medicinal Products: review of - and, if necessary, changes to - the work plan for the subgroup dealing with this subject
Art. 5 (3) "Referral on Heparin": completion of the investigation and follow up in co-operation with CHMP
Plans with varying priorities also result in collaboration with the European Commission. High priority has been assigned to the further development of the Eudra-GMP database as well as to the practical implementation of anti-counterfeit/falsification legislation and the contact to potentially new member states (e. g. Croatia) with regard to GMP inspections. Low priority tasks are Good Practices for blood and tissue establishments and the new Part III of the EC GMP Guide.
As a separate item, the text lists liaison with other groups (e. g. EDQM, PIC/S).
Final conclusion: The GMP/GDP Inspectors Working Group has set itself an ambitious goal. It is in fact quite ambitious to want to implement all of the listed items with high priority. Even if not all goals are actually achieved within 2010, the pharmaceutical industry will have to reckon with marked changes. We will keep you posted about these changes.