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 –...
MHRA publishes new GMP Data Integrity Guidance
Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document published on 23rd January 2015 provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry –...
Update to EU GMP Chapter 1 – Pharmaceutical Quality System
After a longer period of review and many draft versions the final update to EU GMP Chapter 1 on “Quality Management” comes into operation on 31st January 2013. Here is a summary of the main changes. Title change: The title of the chapter has changed from “Quality...
Management Review – what is it for?
In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place. This article has been updated in...
About Inspired Pharma
We help people in pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected ‘live online interactive’/classroom and online training courses and also provide our global pharma clients with consultancy support. Our ‘live online interactive’/classroom courses are available on a public schedule and also can be customised for in-house delivery at a client site.
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