Questions and Answers on Annex 1
Since the publication of the first draft of the revised Annex 1 of the EU GMP Guideline, we have received many questions about the content and interpretation of the new Annex 1 at our Annex 1 conferences and courses and via the ECA Working Groups. Some of these have answered themselves with the second draft and the publication of the final version in 2022, some not yet. In some cases, readers/users of Annex 1 also find it difficult to find the correct passages of Annex 1 or to interpret them to answer their ambiguities. This may be due to linguistic difficulties, unclear formulations or even gaps in this Annex 1 that do not provide an answer or perhaps only in connection with other regulations.
With the questions and answers we want to provide support for the implementation of Annex 1. The answers to the questions we received during past events are based on the opinions and experiences of the members of the Annex 1 Task Force (please also see their comments to the Annex 1 drafts), the CCS Task Force (that developed the Contamination Control Strategy Guide) as well as on the answers of the speakers at the events.
Please also note the current Intensive Training on Annex 1
on 3/4 July 2024
The now published version was compiled from the collected questions and answers by Dr Ingrid Walther (Chair Annex 1 Task Force, co-author of the CCS Guide), Dr Friedrich Häfele (member of the Annex 1 Task Force) and Robert Schwarz (member and co-author of the CCS Guide). Further questions and answers will be added continuously.
To download the Questions and Answers on Annex 1, please use the contact form.
Disclaimer
We received numerous questions during our Annex 1 events, at comment meetings and directly from our members. The answers were given by members of the Annex 1 Task Force, the speakers at the Annex 1 events and a representative of the supervisory authorities to the best of their knowledge, technical expertise, and experience. Dr Ingrid Walther, Dr Friedrich Haefele, Robert Schwarz are named here as representatives. However, in some cases there is still a lack of practical experience and the respective local authorities have room for discretion and interpretation. Factors such as the product to be manufactured, the given premises, production processes and much more also play a role in the implementation of Annex 1. For this reason, this Q&A document is intended to provide suggestions and assistance, but cannot represent a general guidance for the processes in individual companies.
As far as possible, we have assigned the questions to individual subject areas in Annex 1 and listed them under a corresponding heading.