Quality Assurance or Quality Control?
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...
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 –...
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...
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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