Cherwell to attend two events in May focused on the revision of EU GMP Annex 1

By Gill Power

How Cherwell can help customers to improve their environmental monitoring

 Bicester, UK, 1st May 2018: Cherwell Laboratories will be offering expert knowledge and demonstrating their comprehensive range of specialist environmental monitoring and process validation products at two events focused on the revision of EU GMP Annex 1 in May 2018. At both events, Cherwell can advise visitors on how to improve environmental monitoring following the eventual publication of this significant amendment...

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EU GMP Annex 1 Revision Joint PHSS and PQG Conference Overview

By Andrew Ramage

Following the release of the draft copy of EU GMP Annex 1 for public consultation, PHSS jointly with PQG (Pharmaceutical Quality Group) organised a conference for its members to question one of the authors of annex 1, and to openly discuss the annex 1 along with the response that PHSS and PQG will be sending to the EMA. Sales Manager, Andrew Barrow and myself were delighted to represent Cherwell Laboratories at our stand. It would be fair to say PHSS initially underestimated the level of...

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EU GMP Annex 1 update: The devil’s in the detail – part 2

By Andrew Ramage

Writing a blog to cover the updates made to EU GMP Annex 1 – Manufacture of Sterile Medicinal Products was quite a challenge due to the sheer amount of new content. Previously I covered changes and updates to the control of personnel, premises and water systems. Now for the rest…

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EU GMP Annex 1 update: The devil’s in the detail – part 1

By Andrew Ramage

 

Well, it’s almost here. The much anticipated, updated version of EU GMP Annex 1 – Manufacture of Sterile Medicinal Products was published for consultation in December. Over the last few years, Andrew Hopkins of the MHRA and project leader, promised a great deal more detail in the new version, mainly due to a loss of knowledge in recent years caused by experienced staff in the sector retiring. Hopkins is true to his word. The draft annex 1 is a far more detailed document, and arguably...

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