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 traditionally been done it is certainly not the best way of auditing by modern standards.

Do QC labs work to GLP?

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.  GLP stands for Good Laboratory Practice, and this is the system used to cover the performance of toxicological studies on an animal, done as part of medicinal product development. 

New structure to EU GMP

The structure of European Union (EU) GMP has been adjusted slightly as can be seen from the EUDRALEX web-site. A new Part 3 has recently been introduced.  For some time now GMP has been split into 2 Parts.

The benefits of being IRCA registered

Our 5-day Pharmaceutical Lead Auditor course is registered with IRCA, the International Register of Certificated Auditors.  This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses. 

History of the Orange Guide

Pharmaceutical manufacturing sites in the UK will be more than familiar with the “Orange Guide”.  This British publication has for decades contained the requirements of Good Manufacturing Practice.  This article provides a brief overview of the history of this book and also covers why it is certainly no longer a guide.

First published in 1971 the original Orange Guide contained British Good Manufacturing Practice and was entitled “Guide to Good Pharmaceutical Manufacturing Practice”.  Not much more than 30 pages in length this voluntary guide was an aid to manufacturers to understand the needs of the regulatory authority’s requirements for the manufacture of pharmaceutical products.