analysis of draft 2 of annex 1 of the EU GMPs
As you may be aware, the second draft of Annex 1 has been issued for consultation by the European Commission
The draft and methods of submission for comments is available at Eudralex volume 4 – Annex 1 Revision Consultation
The consultation period will finish on 20 July 2020.
Our consultants have reviewed the second draft and compared it to the first draft, highlighting the changes between the two and pointing out our view of potential impacts. This review is available free of charge by contacting info@compliancegroup.eu
As a follow on service, we will run a number of webinars on different days and timings to accommodate different time zones.
The webinars will focus on the likely impacts of the new Annex 1, based on the themes which have come through our reading of the two drafts. Specifically, the implications of the contamination control strategy and the additional new technical requirements which may be introduced.
The next planned webinar will take place from 15:00 to 17:00 (Irish time) on Wednesday 3 June. There is a €200 registration fee payable per person per webinar.
Registration is not currently available. However, if you have any specific questions on the subject matter or would be interested in looking at the option of running this course in-house for your team, please contact us at training@gxp.ie