The revised Annex 1 of the EU GMP Guideline, came into force on August 25th, 2023.
The revised Annex 1 of the PIC/S GMP Guideline (PE 009) on the manufacture of sterile medicinal products was adopted by the PIC/S Committee on September 9, 2022 and came into force on August 25, 2023 (with the exception of point 8.123, which will become binding from August 25, 2024).
At the end of October, Swissmedic published a document on the interpretation of Annex 1.
The document is a list of questions on various chapters of Annex 1 and the corresponding answers as interpreted by Swissmedic.
It includes the following sections:
1 Purpose and scope
2 Basics
3 Definitions and abbreviations
4 Interpretation: Questions and Answers
4.1 Scope (Annex 1, Chapter 1)
4.2 Premises (Annex 1, Chapter 4)
4.3 Utilities (Annex 1, Chapter 6)
4.4 Personnel/Training (Annex 1, Chapter 7)
4.5 Production and Specific Technologies (Annex 1, Chapter 8)
4.6 Environmental & Process monitoring (Annex 1, Chapter 9)
4.7 Quality Control (QC) (Annex 1, Chapter 10)
5 Changes to the previous version