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Posts tagged ‘quality’


February 20, 2012

Dominic Parry

Around a pharmaceutical manufacturing site there will be many measuring devices that require calibration.  GMP requires the calibration of such devices with similar requirements in both EU and USA GMP, as can be seen below: Read more

Proposed update to EU GMP Chapter 5 “Production”

February 13, 2012

Dominic Parry

What’s new in the latest version?

The EU GMP Chapter 5 on Production is currently being reviewed.  A draft update document is currently available.  This article is a commentary on the DRAFT version currently in circulation.  Many of the suggested updates are in-line with existing good practices.  Some of the main suggested changes are summarised below.  You should refer to the actual document, Chapter 5 Draft, for the full details.  There is no news on if and when this update comes into force yet. Read more

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