GXP

EU GMP Annex 1: What The ‘Final’ Draft Reveals

The new draft is generally similar to the December 2017 version, although there are some notable differences and the draft is, overall, easier to read and the use of scientific terminology is more consistent. This time the review process is more focused, with specific sections called out for review, and comments are only being sought from invited professional bodies or professional bodies who have written in expressing a desire to be involved with the review (which then required approval by the EMA). According to EMA (4): “Due to widespread interest from industry following the first targeted...

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