CAPA – time for a rethink?

CAPA – time for a rethink?

All manufacturing sites have a CAPA system, usually a mechanism to deal with things that have gone wrong.  Despite the fact that a lot of focus has been given to CAPA in recent years, there is a great deal of misunderstanding and a clear lack of clarity on what CAPA...
ISO 9001 versus GMP – Part 2

ISO 9001 versus GMP – Part 2

A lot has been said about ISO 9001 in the pharmaceutical industry.  This article tries to compare the two fairly.  You should read Part 1 first to get some idea of the differences.  One of the main problems of comparing GMP and ISO is that the two standards are not...
ISO 9001 versus GMP – Part 1

ISO 9001 versus GMP – Part 1

A lot has been said about ISO 9001 in the pharmaceutical industry.  With pros and cons and comparisons to GMP made all the time.  This will be discussed more in a later article, but as a starter I have listed the clauses of ISO 9001:2015 below.  Those in green text...
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...