Pharma News and Articles
Read our articles on pharmaceutical regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent pharma articles are shown in the slider and the rest are shown in date order below.
History of the Orange Guide
This article provides a brief overview of the history of this book and also covers why it is certainly no longer a guide.
Documents required by USA GMP (21 CFR 211)
The article covers the requirement of written procedures required by 21 CFR 211
What is a medicine?
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!
Inspired Times – Newsletter November 2022
"Wow - Amazing - World Class" - "truly inspiring training" Amazing feedback on our courses Our IRCA registered Pharmaceutical GMP Auditor/Lead Auditor Course continues to received outstanding feedback from delegates. The words in the headline above are just an...
Documents required by EU GMP
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”.
GMP Calibration
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
Dealing with problems – for good
Problems happen in work and in life. Problems also happen within any quality system. GMP requires problems to be dealt with correctly.
CAPA – time for a rethink?
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.
ISO 9001 versus GMP – Part 2
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 – Part 1
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
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