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The benefits of being IRCA registered

The benefits of being IRCA registered

Our 5-day Pharmaceutical GMP Auditor/Lead Auditor Course is registered with IRCA, the International Register of Certificated Auditors (IRCA Ref:PR325).  This is the world’s premier organisation for professional auditors and sets down minimum standards for...
Raising non-conformities

Raising non-conformities

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing and whilst it may be the way audits have...
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...
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...