Cherwell Publishes Guide on Environmental Monitoring Processes and Validation

By Gill Power

 

Supporting EM programs in preparation for proposed EU GMP Annex 1 changes

 

Bicester, UK, 18th July 2018: Cherwell Laboratories, specialist supplier of products for environmental monitoring and process validation, has drawn on its in-depth pharmaceutical and related industry knowledge to publish an eBook titled, “The Environmental Monitoring Processes and Validation Guide.” 

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Environmental monitoring: How to maintain a cleanroom

By Andy Whittard

Your environmental monitoring (EM) program must demonstrate control over both viable and non-viable particles found in critical areas of your operation. The procedures and protocols you have in place must ensure asepticism throughout your operation.

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PHSS Annual Challenges in Sterile Product Manufacturing Meeting 2018

By Andrew Ramage

It is always a pleasure to attend the PHSS steriles meeting as there are always many fascinating topics being presented and discussed. This year had an excellent selection of talks about the latest trends and discussion points in the manufacture of sterile drugs. Sales Manager, Andrew Barrow and I attended on behalf of Cherwell Laboratories. The event was held on the 7th June, at The Mere Hotel & Spa in Knutsford for the second consecutive year.

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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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