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.
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!
Back in December 2017, we published a blog, taken from our guide “The pharmaceutical industry’s guide to prepared culture media” specifically about the factors to consider when storing growth media. One of the most frequent questions I am asked by customers looking for technical help are factors that affect growth media, usually accompanied by a scenario where they are worried the performance of the media is affected by a specific or number of...
Formaldehyde was long considered the undisputed fumigation champion for ridding your cleanroom (and all other aseptic spaces) of any and all contaminants. Then, in January 2016, EU legislation reclassified formaldehyde as a class 1B carcinogen and class 2 mutagen, placing the widespread use of this popular chemical under scrutiny.
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...