Since the revised EU GMP Annex 1 became effective on 25 August 2023, and with PIC/S PE 009-17 aligning the same expectations across participating authorities, many organisations are facing the same recurring questions:
- Which contamination control requirements actually apply to our processes – and how do we evidence them?
- How do we keep cleanrooms, procedures and monitoring programmes compliant between qualifications, not only on the day of testing?
- What documentation, risk assessments and qualification strategies do inspectors actually expect to see?
- How do we deliver all of this without stopping production?
This isn't only an industrial concern. Hospital pharmacies and compounding centers face a parallel shift under PIC/S PE 010-4, the guide for preparing medicinal products in healthcare establishments. In Belgium, it became binding for hospital pharmacies from 1 January 2026 under the Royal Decree of 30 September 2020, with FAGG inspectors assessing compliance directly. The same questions above apply here too, even outside the industrial GMP framework.