News about GMP/cGMP

26.08.2016

EMA issues Q&As on Data Integrity

EMA has added the topic of Data Integrity to its list of Q&As regarding the overall area of EU-GMP.

 

Listed are 23 frequently asked questions with the official interpretation of the EMA, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group. Amongst others this includes questions on data lifecyle risks, on self-inspection or on contractors.

The EMA-list with a total of 87 frequently asked questions on EU-GMP is updated on a regular basis.


Source:

EMA: Q&A-List on EU-GMP

 



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