The two regulators Andrew Hopkins and Tracy Moore standing in the hallway of the SKAN AG headquarters and smiling at the camera

In our exclusive expert interview, we discuss the latest developments in the industry and highlight the impact of the revised EU GMP Annex 1. Tracy Moore from TM Pharma Group Ltd. and Andrew Hopkins, an expert in microbiological contamination control, offer valuable insights.

Watch the video to:

  • Gain insight into the key goals of Annex 1
  • Discover essential steps for compliance like establishing a contamination control strategy (CCS)
  • Understand how Annex 1 affects cGMP, especially regarding barriers.

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.

Contact the sales team now!