This is a commonly asked question on my training courses which is generally misunderstood.  Quality Control (QC) laboratories that are based at classic pharmaceutical manufacturing sites DO NOT work to GLP.

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 auditors and auditor training courses.

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.This article the best way of dealing with non-compliances using modern standards.

This article provides a brief overview of the history of this book and also covers why it is certainly no longer a guide.

The article covers the requirement of written procedures required by 21 CFR 211

A medicine is quite a complicated thing, with a number of definitions that go beyond “making you feel better”.   Whilst making you feel better is probably the goal of all medicines you will see in this article that these four words do not appear in the definition itself!

The list below details the documented procedures specified as being required by EU GMP. It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.