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Quality Assurance or Quality Control?

Quality Assurance or Quality Control?

by | 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...
The Focus of Audits – Have we got it right?

The Focus of Audits – Have we got it right?

by | Sep 12, 2022

Most people will have some involvement with being audited.  In general audits are classified into one of three different types; namely first party, second party and third party. First party audits are often called internal audits or self-inspections.  Here you are...
Key GMP personnel and their duties

Key GMP personnel and their duties

by | 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 –...
Update to the EU’s Good Distribution Practice guidelines

Update to the EU’s Good Distribution Practice guidelines

by | Mar 13, 2013

Good Distribution Practice, or GDP, is the standard used to cover the movement and transport of materials.  Historically GDP covered the movement of finished product from the pharmaceutical manufacturing site to the wholesalers and retailers and strictly speaking this...