A medicine is quite a complicated thing, with a number of definitions that go beyond “making you feel better”.   Whilst making you feel better is probably the goal of all medicines you will see in this article that these four words do not appear in the definition itself!

The list below details the documented procedures specified as being required by EU GMP. It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.

Around a pharmaceutical manufacturing site there will be many measuring devices that require calibration. GMP requires the calibration of such devices with similar requirements in both EU and USA GMP

Problems happen in work and in life.  Problems also happen within any quality system. GMP requires problems to be dealt with correctly.

Most manufacturing sites these days have CAPA systems – a mechanism to capture, record, control and approve or reject Corrective Actions. However despite this approach many organisations feel that they are still in “fire-fighting” mode – always dealing with yesterday’s problems rather than preventing future issues from occurring.

One of the main problems of comparing GMP and ISO is that the two standards are not the same and are not really trying to do the same thing. This article highlights the key differences.

ISO 9001 versus GMP – this article lists the clauses of ISO 9001:2015 identifying requirements of ISO that are not specifically mentioned in EU GMP