EU GMP Annex 1 Revision

Key goal underlying Annex 1

• The overall goal of Annex 1 is to secure the safety of the product and thus the patient.
• This can be achieved by a stringent contamination control strategy, which tries to eliminate the biggest contamination risk “operator”.

Key changes of the Annex 1

• The requirements of Annex 1 mostly aren’t “new”. They are just more clarified now.
• One key part is the need for a contamination control strategy. This strategy should be seen as a roadmap to reach a fully Annex 1 compliant production. Yet, many of the required documents already exist and only need to be linked as a holistic strategy.

Key requirements of the Annex 1

• Isolators or closed RABS are required as barrier systems.
• The isolator requires at least a grade C environment.
• PUPSIT is required with only very few justified exceptions.
• The operator needs to be eliminated from the processes as much as possible (e. g. by using rapid transfer ports for stoppers)

Key steps to Annex 1 compliance

• The best preparation for Annex 1 compliance is to conduct a gap analysis: review existing processes and risk assessments and evaluate if they are still current.
• Knowledge management should be seen as key part of quality risk assessments.
• Until you can reach a fully Annex 1 compliant production, you need to have interim measures in place to secure product safety.
• Companies continuously need to adapt to evolving new technologies.

Andy’s final tip

• Don’t over-complicate! The CCS is a commonsense strategy, which contains possible risks during each production process and how to minimize them.