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…
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...
Prepared agar plates are one of the most popular forms of prepared culture media. While agar is chiefly used in the laboratory, this polymer has an interesting history and is very useful outside of the scientific world too. But where does it come from, and why do we favour this substance over any other?
Any businesses requiring agar plates for successful testing and microbial growth activities need to know two things: that all agar plates are guaranteed to be of high quality and offer reliable results; and that confidence in your supplier is rooted in provable standards, certifications and validated processes.
Prepared media in the form of agar plates is used in all sorts of industries, from microbiology to beer manufacture, for a variety of applications. Across all industries that use these plates, a common debate endures: is it best to manufacture them in house, or buy in from an external supplier?
For the third consecutive year I managed to find myself at the Pharmig Annual Conference. This year it was held at the Crown Plaza, Heythrop Park just down the road from Cherwell near Chipping Norton. As per usual there was a packed schedule full of interesting talks and discussions. I have already covered the open discussion sessions in my previous blog; this is a quick summary of the other talks from the 29th and 30th November.
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.