The following new EU guidelines are addressed:
- The publication of a final text of Annex 21 of the EU GMP Guide is scheduled for Q4 2018.
- Finalisation of a reflection paper on the relationship between GMP compliance and the responsibilities and activities of Marketing Authorisation Holders and Manufacturing Authorisation Holders, again in Q4 2018.
- Finalisation of the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container in Q2 2018
EU guidelines planned to be revised are:
- The introduction of the EU GMP Guide will be revised in Q4, in view of recent changes to the legal basis for GMP affecting the overall structure of EU GMP guidance including authorised products, IMPs, ATMPs and active substances.
- Chapter 1 (Pharmaceutical Quality System) is planned to be amended to encourage industry to adopt risk-based approaches in Q4.
- Chapter 4 (Documentation) and Annex 11 (Computerised Systems) will be amended to assure data integrity in the context of GMP in Q4.
- A final text of Annex 1 (Manufacture of Sterile Medicinal Products) shall be provided for the European Commission once the public consultation period is closed.
- A draft guideline on the manufacture of the finished dosage form shall be released for public consultation in the first quarter of 2018.
- The draft guideline on quality of water for pharmaceutical use shall be released for a six month public consultation in Q3 2018.
- The development of ICHQ12 (Lifecycle Management), which is currently in Step 2b, will be further supported with a particular emphasis on GMP inspection and Pharmaceutical Quality System aspects.
- Finally, a Q&A on the implementation of the updated shared facilities guidance is scheduled to be published in Q2 2018.
EMA: 2018 Work Plan GMP/GDP Inspectors Working Group