Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document published on 23rd January 2015 provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry –...
The structure of European Union (EU) GMP has been adjusted slightly as can be seen from the EUDRALEX web-site. A new Part 3 has recently been introduced. For some time now GMP has been split into 2 Parts. Part 1 covers conventional GMP for finished pharmaceutical...
The deadline for public comments on the concept paper on revising EU GMP Annex 16 – Certification by a Qualified Person and batch release is due in just a few weeks. Closing date is 31st January 2012. Problem statements (from the concept paper) What is the...
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