Friday, 13 April 2018

Work plan for the GMP/GDP Inspectors Working Group for 2018

The European Medicines Agency has published its work plan for 2018:

“The activities outlined in the work plan for 2018 have been agreed in view of preparation for the Agency’s relocation as a result of the UK’s exit from the EU and its impact on the Agency’s business continuity, and may be subject to further review and reprioritisation in accordance with the business continuity plan of the Agency.”

Included in the plan is:
  • GMP Guide: Annex 21 (Importation of medicinal products) - Target date Q4 2018: “To provide the European Commission with a final text for publication.” 
  • Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container, EMA/CHMP/CVMP/QWP/BWP/850374/2015 (H/V). Target date Final guideline to be published Q2 2018: “Public consultation of the draft guideline ended 13 October 2016”.
  • GMP Guide: Chapter 1 (Pharmaceutical Quality System). Target date Q4 2018: “To draft a proposal to amend the chapter in order to encourage industry adoption of risk-based approaches to prevention of shortages, taking account initiatives such as HMA-EMA Taskforce and the industry inter-association guidelines.
  • GMP Guide: Chapter 4 (Documentation). Target date Q4 2018: “To draft a proposal to amend the chapter in order to assure data integrity in the context of GMP. This would be in parallel with similar consideration of Annex 11 (Computerised Systems).”
  • GMP Guide: Annex 11 (Computerised Systems). Target date Q4 2018: “To draft a proposal to amend the chapter in order to assure data integrity in the context of GMP. This would be in parallel with similar consideration of Chapter 4.”
  • Guideline on quality of water for pharmaceutical use (H+V) Target date Draft guideline to be released for 6 month public consultation Q3 2018.
  • ICH Q12 (Lifecycle Management). Step 2b initiated in November 2017 - developing the guideline with particular emphasis on GMP inspection and Pharmaceutical Quality System aspects.



Posted by Dr. Tim Sandle

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