What GMP Changes can we still expect for 2014?

Heraclitus once said: "There is nothing permanent except change". This statement is even true for the rather conservative GMP environment. What can we still expect for 2014? The answer to that question can be found in a work plan of EMA's GMP/GDP Inspectors Working Group.

What are the coming plans?

  • Finalising the changes planned for the Chapters 3 and 5 of the EU GMP Guide
  • Finalising the revision of Chapter 8 of the EU GMP guide (with regard to product shortage notifications and specific risk management concepts)
  • Agreeing, in consultation with PIC/S, whether guidance is needed on biofilms concerning Annex 1 of the EU GMP Guide
  • Finalising the revision of Annex 15 of the EU GMP Guide (comparison with the new EMA process validation guideline and inclusion of necessary changes in the light of ICH Q 8-10)
  • Finalising the revision of Annex 16 of the EU GMP Guide
  • Finalising the revision of Annex 17 of the EU GMP Guide
  • Further measures regarding the EudraGMDP database

The finalisation of the revision of Chapter 6 (Quality Control) of the EU GMP Guide is already completed (April 2014). The revised chapter will apply as of October 2014.

The following topics are also addressed in the work paper:

  • Inspections under the centralised system
  • Mutual Recognition Agreements (MRAs)
  • Harmonisation topics
  • Collaboration with the EU Commission (the collaboration should enable by the end of 2014 the publication of the GDP guidelines for APIs and  the risk assessment guidelines to establish GMP for excipients)
  • Collaboration with other groups (i.e. Reverse Osmosis for the production of WFI and biological indicators for monitoring and the control of sterilisation are topics addressed together with the EDQM in Strasburg)

Please also see the complete "Work plan for GMP/GDP Inspectors Working Group for 2014".

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