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Quality Assurance or Quality Control?

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

The Focus of Audits – Have we got it right?

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

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

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...