Annex 1 2022 Section 6: Utilities

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6. The level of control of Utilities such as water, steam, compressed gases and so on depends on risk which should be documented in the contamination control...
Annex 1 2022 Section 1: Scope

Annex 1 2022 Section 1: Scope

In the first article I summarised the background to the latest update to Annex 1. In this article I want to focus on sections 1, “Scope”. The scope of a document is usually intended to outline the range of application of the document. It can be used to summarise areas...
History of the Orange Guide

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...
What is a medicine?

What is a medicine?

When I am running GMP training courses I often ask the delegates at the start of the course what a medicine actually is.  This always prompts some interesting discussion and gets people thinking – which is never a bad thing on a training course.  Typical answers...