GMP Validation
@GMPValidation
Pharmaceuticals GMP Validation PharmOut
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US FDA release a preliminary report on the New England Compounding Centre pharmout.net/blog/335/
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Distribute.IT admits that customer data hosted on its servers may be unrecoverable http://bit.ly/jDdzPJ
Two new guidance documents available! ISPE Good Practice Guide: Cold Chain Management http://bit.ly/mKnVEP and ...
Back in Singapore for more computer systems validation - good fun
Writing a VP & a URS for a BMS & a Biometric Access system - & enjoying it!
Just did a lab audit of a medical device manufacturer in Sydney. They were pretty good. Documentation lets a lot of companies down though.
Listening to the FDA's Joseph Famulare at the ISPE conference in Singapore.
IVT's CSV conference. Warning letters for medical devices on the rise. http://bit.ly/12yH2Y
Developing GAMP5 templates to help companies speed up validation of their computer systems.
GSK had to recall Seretide 250 Evohaler in Britain due to counterfeiters!! www.mhra.gov.uk/Publications/Safetywarnings/Drugalerts/CON046565
ICH web site has a new page with presentations - under construction but looks good. 'http://www.ich.org/Main.jser?@_ID=5179'
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