The draft revision of the EU GMP Annex 1 has been received with mixed feelings. The European Medicines Agency (EMA) is currently working its away through the 6000+ comments that have come about since the release of this revision.
The revised EU GMP Annex 1 guidelines for manufacture of sterile medicinal products may still be some way off publication, but the latest draft revision offers highly relevant information that can be used to improve compliance and reduce risks.
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.”
One of my many functions at Cherwell Laboratories is to be the first point of contact for all distributor enquiries. As mentioned in previous press releases we have enjoyed a significant increase in sales of Redipor® prepared media over the last few years to mainland Europe and South Korea. This is due in no small part to our distributors working very hard to establish the Redipor® brand in their territories and the high quality of the media sold. My job is to offer technical advice on...
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.
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.
With the new draft revision of EU GMP Annex 1 demonstrating the highest standards in patient safety, all healthcare businesses, that make use of cleanrooms in their manufacturing and production activities, are paying fresh attention to their environmental monitoring policies. This draft revision is also considered a big step towards creating a recognised global standard for the maintenance of cleanroom environments; hence the level of detail.
A recent trip to Amsterdam threw up an unexpected little gem all about the fascinating world of micro-organisms and microbiology. Now I have to admit that this wasn’t something we went looking for, the normal attractions of canals, Van Gogh, tulips, pancakes, etc. were our main focus. As were places to eat and how to get about – the public transport in Amsterdam is first rate!
Cherwell’s recent inaugural distributor meeting at its Bicester-based production facilities enabled valuable knowledge sharing opportunities
Bicester, UK, 23rd May 2018: Cherwell Laboratories, manufacturer of Redipor® prepared microbiological media, announced a 21% increase in Redipor sales to its distributors during its 2017/18 financial year. Cherwell’s continuing growth in export sales, largely across Europe, can be...