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GMP Calibration

GMP Calibration

GMP Calibration – understand both EU and USA GMP requirements Around a pharmaceutical manufacturing site there will be many measuring devices that require GMP calibration.  GMP requires the calibration of such devices, with similar requirements in both EU and...
Key GMP personnel and their duties

Key GMP personnel and their duties

Some of the most popular articles on our blog are the four we published some four years ago about  key GMP personnel and their duties. These can be found through these links: Part 1 – Production, QC and QP personnel Part 2 – QA personnel Part 3 –...
Duties of key personnel in GMP – Part 3 (Engineering)

Duties of key personnel in GMP – Part 3 (Engineering)

From Parts 1 and 2 of this post we highlighted that there is no formal need for an Engineering Manager or Department in GMP.  In the manufacture of medicines the equipment used and the environment it is located in has a massive impact on product quality.  The role of...