High priority GMP/ GDP Topics

GMP Guide: Chapters 1 and 2 (Quality Management and Personnel)

To update these chapters as part of the EU implementation of ICH Q10.

GMP Guide: Chapters 3 and 5 (Premises and Equipment and Production)

To finalise proposals for the revision of guidance on the circumstances where certain products should be produced in dedicated and self-contained facilities and to share this with US FDA prior to the launch of a public consultation. To re-consider progression of the further proposed amendment to Chapter 5 of the GMP Guide developed in 2008. This was developed in order to reflect, in guidance, the obligations of manufacturing authorisation holders to only use active substances that have been manufactured in accordance with GMP, and, to clarify analytical testing expectations of medicinal product manufacturers with respect to raw materials.

GMP Guide: Chapter 7 (Contract Manufacture and Analysis)

To revise the chapter with the principle aim of updating and widening the scope of guidance on outsourcing.

GMP Guide: Chapter 8 (Complaints and Product Recall)

To consider a revision in the light of discussions at a meeting of Quality Defect contact points held at EMEA on 7-8 October 2009 on product shortage notifications and to introduce specific Quality Risk Management concepts in the context of this chapter.

GMP Guide: Annex 2 (Biological substances and Medicinal Products)

To finalise revision of the Annex in response to the public consultation conducted in 2008 and to request the European Commission to carry out a second public consultation. To organise a meeting with specific interested parties during the public consultation.

GMP Guide: Annex 11 (Computerised Systems)

To finalise the revision of the Annex following the public consultation conducted in 2009 and to request the European Commission to adopt and publish it together with consequential amendments to Chapter 4.

GMP Guide: Annex 14 (Medicinal Products Derived from Human Blood or Plasma)

To agree on a final text for transmission to the European Commission on the amendment of the annex initiated in view of Directive 2002/98/EC.

Good Distribution Practice (GDP)

To finalise a draft revision of the Community GDP guideline and forward to the European Commission to release for public consultation.

Outcome

Be prepared for innovations concering documents to be finalised in 2010 and take part in the public consultacion process.

Link/Source

2010 Work Plan for the GMP/GDP Inspectors Working Group