MHRA guidance sets for data integrity in GMP

The MHRA guidance set contains examples, expectations and definitions on GMP data integrity for the GMP regulated industry and was published on 23rd January 2015 .

It complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards (EU EudraLex Volume 4 – Annex 11 anc Chapter 4 – Documentation). It is also useful for US-FDA 21 CFR Part 11 compliance – refer to Q&A on cGMP – Records and Report from August 26, 2013.

Links:

• MHRA – announcement
• Download guidance document

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