by Dominic Parry | Sep 22, 2022
EU GMP states that Quality Control (clause 1.9) “is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures”. In essence, QC is a sampling, testing, monitoring and checking activity. GMP also defines the...
by Dominic Parry | Mar 10, 2016
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 –...
by Dominic Parry | Jan 25, 2015
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 –...
by Dominic Parry | Oct 26, 2012
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...
by Dominic Parry | Sep 10, 2012
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...