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...
The positioning of the Qualified Person (QP) within the organisation
In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnel required by EU GMP, namely the Head of Production, the Head of Quality Control (QC) and the Qualified Person (QP). In this post we look at the organisation of these people...
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