News & Media

Annex 1: 2008 vs 2017 draft

09 Novembre 2018 News


  • Relevance given to QRM and QA
  • Utilities: water and biofilm
  • Production and specific technologies: filtration of medicinal products which cannot be sterilized in their final container
  •  Viable and non-viable environmental & process monitoring

Quali sono le attività di PDA e le prossime fasi della revisione?

  • Viable Expert team made up of 16 sterile product manufacturing experts from 14 companies, representing Europe, Japan, the U.S., and PDA
  • Considered comments and input from PDA membership in formulating expert team opinions, as well as existing published PDA positions
  • Team debated positions and formulated comments and proposed recommendations for EMA
  • Submitt ed approximately 90 specific comments and a dozen general comments to PDA science and regulatory advisory boards
  • Once approved by ABs, Board, and senior staff , comments will be published and sent to EMA
  • Comments included positive feedback on several beneficial changes to the Annex and where needed, recommendations for clarification
  • PDA stressed need for risk based decision making and flexibility, clarity of intent, adoption of modern scientific terminology, and consistency in approac
  • PDA proposed scientific and technical modifications to help enhance and clarify the Annex

Non perdere l'appuntamento del 6 marzo con Clean Room 2019 per un focus specifico ANNEX 1 con:

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