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Posts tagged ‘Qualified Person’

Update to EU GMP Chapter 2 – Personnel

December 16, 2013

Dominic Parry

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A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014.  Here is a summary of the main changes from the previous version Chapter 2 Personnel OLD.  A copy of the new version can be found by clicking on the link Chapter 2 Personnel NEW. Read more

Proposed update to EU GMP Chapter 2 “Personnel”

February 22, 2012

Dominic Parry

This article provides an overview of the current proposed changes to EU GMP Chapter 2 on Personnel.  As with similar blog articles before on Chapters 4, 5 and 8 readers are reminded that the proposed update is still in the DRAFT format (Chapter 2 Draft) and is therefore not yet a requirement of GMP at the time of writing.  Readers should also refer to the actual document for full understanding.

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Proposed update to EU GMP Chapter 4 “Documentation”

February 2, 2012

Dominic Parry

What’s new in the latest version?

The EU GMP Chapter 4 on Documentation came into force on 30th June 2011.  Many of the updates were in-line with existing good practices.  Some of the main changes are summarised below.  You should refer to the actual document,  Chapter 4 Documentation , for the full details.

In general there is increased coverage of the use of computer systems

This reflects the increase in use of computers, coverage in GMP has been poor historically and limited mainly to Annex 11. Read more

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