Posts tagged ‘Qualified Person’
February 22, 2012
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.
February 2, 2012
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