Swissmedic: Technical Interpretation on Annex 1 Published
On 31 October 2023, Swissmedic published a Q&A with the title "Interpretation of GMP Annex 1 2022 (Rev. 1)". In the 25-page document, the Swiss Agency for Therapeutic Products provides key answers to questions related to Annex 1, which came into force in August 2023, and to repeatedly asked questions from the previous version.
The interpretation is intended to reflect the "general opinion of the Swiss inspectorates on these topics and serve as support for the inspection of manufacturers of sterile medicinal products." Therefore, the document is of special interest to sterile manufacturers. It is based on the revised Annex 1 of the PIC/S-GMP Guideline (PE 009) which is identical in wording to Annex 1 of the EU GMP Guide except for some minor adjustments.
The technical interpretation answers 46 questions relating to the following chapters of Annex 1:
- 1. Scope
- 4. Premises
- 6. Utilities
- 7. Personnel/Training
- 8. Production and Specific Technologies
- 9. Environmental & Process Monitoring
- 10. Quality Control (QC)
The document is available in English on the Swissmedic website under the section "Inspectorates".
Source:
Swissmedic: Interpretation of GMP Annex 1 2022 (Rev. 1)
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