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.
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– MUST READ – MUST READ – MUST READ –