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...
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…
Bicester, UK, 17th January 2018: Cherwell Laboratories, specialist suppliers of products for environmental monitoring and process validation, has published an eBook titled, “The Pharmaceutical and Cleanroom Industry’s Pocket Guide to Prepared Culture Media”.
Cherwell Laboratories were proud to sponsor one of the discussion sessions at the 25th annual Pharmig conference at Crown Plaza, Heythrop Park near Chipping Norton in Oxfordshire. I was co-host of the first discussion session with Cherwell's Sales Manager, Andrew Barrow. I also attended the second session on environmental monitoring, which Steris sponsored.
The question of whether to use externally sourced prepared media or whether to produce in-house is one that goes beyond cost and preference. For some manufacturers, there is simply no other option but to create a bespoke product in-house.
A major industry survey, started by Pharmig at its 24th Annual Conference in Nottingham, followed by a questionnaire sent to Pharmig members, revealed 91 per cent of respondents source some or all of their prepared media plates from external suppliers. The survey was devised to investigate quality control activities around prepared culture media within the pharmaceutical and healthcare industry.
In this third instalment of our Recommended Research Papers series, I have included a collection of six articles. All of them have piqued my interest as they tackle some extremely pertinent issues in our industry.
Our first edition of Recommended Research Papers for Cleanroom Operators gathered quite an audience. Thanks to each of you who responded to our call for recommendations for this and future editions.
Providing a quick guide on validation standards and regulations
Bicester, UK, 28th July 2017: Cherwell Laboratories, specialist suppliers of products for environmental monitoring, cleanroom bio-decontamination and process validation, has published a booklet titled “The Pharmaceutical Lab’s Pocket Guide to Cleanroom Decontamination”.
Aseptic compounding at the GOSH Pharmacy Unit
Bicester, UK, 18th July 2017: Cherwell Laboratories, specialists in products for environmental monitoring and process validation, has recently supported the Great Ormond Street Hospital (GOSH) Pharmacy Unit in developing a new triple-wrapped prepared media product required to ensure the exclusion of bacterial spores during aseptic compounding validation....