21 November 2023

Interpretation of Annex 1 – SwissMedic Publishes Q&A Document

On October 31st , the Swiss Medicines Inspectorate published a technical interpretation of GMP Annex 1, 2022 (Rev 1). The interpretation focuses on some of the most significant changes of the revision 2022 of Annex 1: Manufacture of Sterile Medicinal Products. It also addresses aspects that were already included in the previous guideline version and have consistently prompted questions.


The technical interpretation aims to represent the general opinion of the Swiss Inspectorates on these topics and to function as a support during inspections of manufacturers producing sterile medicinal products.


The document consists of various questions regarding chapters of Annex 1 along with the corresponding answers interpreted by SwissMedic. It includes chapters:


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

While some questions aim to provide further clarification on the language used in Annex 1, there are also several inquiries regarding the assessments of single-use systems (SUS). The document contains a total of 46 questions and their corresponding answers, available directly on the Swissmedic website in the published document titled “Interpretation of GMP Annex 1 2022 (Rev. 1)”.