What happened
PIC/S published Recommendation PI 058-1, titled “Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022).” The document was prepared by experts from the PIC/S-EMA-WHO Joint Implementation Working Group, which includes experts from WHO, EMA and PIC/S Participating Authorities. The group was established in January 2024 after the revised Annex 1 entered into force on 25 August 2023. PIC/S, EMA and WHO formally adopted the recommendation. It was presented to selected stakeholders at an EMA-hosted webinar on 22 October 2026 and entered into force on 28 October 2026.
Why it matters
For pharmaceutical manufacturers involved in sterile production, the recommendation may provide a coordinated PIC/S, EMA and WHO interpretation of major changes in the 2022 Annex 1. Its adoption and entry into force may make it relevant when reviewing sterile manufacturing practices and related GMP documentation against the revised Annex. The source announcement does not describe the individual interpretations, so their specific operational impact cannot be determined from this text alone.
Key topics: Interpretation of revised Annex 1 changes, PIC/S-EMA-WHO joint implementation work, Sterile products manufacturing guidance
Source: Pharmaceutical Inspection Co-operation Scheme (PIC/S)