by Dominic Parry | Jan 28, 2023
This is a commonly asked question on my training courses which is generally misunderstood. Quality Control (QC) laboratories that are based at classic pharmaceutical manufacturing sites DO NOT work to GLP. GLP stands for Good Laboratory Practice, and this is the...
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 | 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 | Apr 24, 2012
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...