PIC/S Recommendation (PI 058-1) - Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products

Date

October 29, 2026

Category

Other Regulations

Description

On 28 October PIC/S announced the adoption and entry into force of their Recommendation PI 058-1 - Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022), see the document at https://picscheme.org/docview/11495

This document was prepared by a sub-group of experts from the PIC/S-EMA-WHO Joint Implementation Working Group (A1IWG) bringing together experts from WHO, EMA, and PIC/S Participating Authorities. The A1IWG was established in January 2024 following the entry into force on 25 August 2023 of the revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide”.