Below is a link to what MHRA inspectors are now getting trained on for inspecting blood establishments, there is also a the manual gives valuable information and guidance on the structure of documents related to quality management systems. The content of this manual will therefore by included in the EU co-funded project on developing common criteria and standards for the inspection of blood establishments.

http://www.gaelcommunity.com/blogs/quality_news/archive/2010/08/18/revised-mhra-inspection-manuals.aspx

Thanks for that Gregor.

:ohmygod::ohmygod:

Hi Malcolm,

No problem, many of my clients are now using this to prepare for the next inspection! We are currently configuring Q-Pulse to manage the checklist with the example evidence and cross reference to the GMP standard.

Thanks Gregor, I was wondering when these were coming out-at last, some more fun bedtime reading!!

Many thanks Gregor. This will be an immense help in my work.

Wow, this is great, Thanks for this I am now sitting highlighting the bits I want to watch.