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...
Documents required by USA GMP (21 CFR 211)
The article covers the requirement of written procedures required by 21 CFR 211. As with the similar blog articles on documents required by EU GMP and ISO 9001 the reader should note that the words “written procedure” are not the same as...
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...
Documents required by EU GMP
There are many activities that you do that are “procedures”, such as how you get in the car in the morning (unlock the door, adjust the seat, fasten seat-belt, start the engine, and so on), but this is (hopefully) not a “documented procedure”! “Documented procedures”...
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