PIC/S, EMA and WHO adopt PI 058-1 interpreting 2022 Annex 1 sterile changes
Key facts
- Type / category
- Standard / Guidance
- Status
- Official
- Agency
- PIC/S (adopted with EMA and WHO)
- Source date
- Effective date
- Sectors
- Environmental
- Reference
- PI-058-1
On October 28, 2026, PIC/S published Recommendation PI 058-1, Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022). The document was prepared by a PIC/S–EMA–WHO Joint Implementation Working Group and was formally adopted by PIC/S, EMA and WHO. PIC/S presented it to selected stakeholders at an EMA briefing webinar on October 22, 2026.
PI 058-1 is a Q&A on the 2022 Annex 1 revision that entered into force on August 25, 2023 (with one delayed point from August 25, 2024). The recommendation states that its purpose is not to introduce any new GMP requirements. Topics include contamination control strategy, premises and barrier technology, utilities, personnel qualification, production and single-use systems, environmental and process monitoring (section 9), aseptic process simulation, and quality control.
Annex 1 itself was not amended by this adoption. Separately, PIC/S revised PE 009-18 Annex 19 (reference and retention samples for parallel trade) in September 2026; that revision is not about sterile manufacturing or environmental monitoring.
This is guidance, which isn't legally binding. It describes the agency's current thinking.
What it means for labs
If your lab supports sterile or low-bioburden work that cites EU GMP Annex 1 or PIC/S PE 009, read PI 058-1 for the joint answers on contamination control strategy, environmental monitoring and aseptic process simulation. Annex 1 itself did not change. The document says it does not introduce new GMP requirements.
Who it affects
Sterile and aseptic manufacturers, and labs that support environmental monitoring or contamination-control programs under Annex 1 / PIC/S PE 009
Sources
- PIC/S news: Adoption and entry into force of PI 058-1 (Oct 28, 2026) (opens in new tab)Official source · PIC/S
- PIC/S Recommendation PI 058-1 PDF (docview 11495) (opens in new tab)Official source · PIC/S
This summary is for general information and may not reflect later changes. Always check the official source linked above. It isn't legal or regulatory advice, and Micro-Core Consulting isn't affiliated with the agencies or standards bodies named.