As the industry moves forward under the revised Annex 1 regulation, this collaboration allows for alignment across our members on the interpretation and implementation of the requirements.
Changes to aseptic manufacturing regulations
The interpretation of the the revised/updated Annex 1 regulation can be subjective in certain areas resulting in a variation in how the various sections are implemented. This results in inspectors seeing different processes on-site or wanting to see parity with one particular interpretation.
- Decisions to be made on investments in upgrading existing lines depending on regulation
- Regulatory changes are not always interpreted uniformly
- On-site inspections will carry a focus on Annex 1 compliance
- Older facilities and filling lines may need to be adapted
- API (Annex 2) processes now have a clearer need to adopt elements of Annex 1, and its role in ATMP is under discussion
The goal of the team is to reach consensus on the interpretation of requirements from both a quality and operational perspective resulting in industry alignment. This is achieved through open and transparent discussion on the challenges leading to multiple benefits:
- Reduced duplication of effort
- Consistency of process development across the industry
- Increased alignment between pharma and external manufacturing partners
FF-Annex 1 deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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