The pharmaceutical industry is full of procedures. This is why GMP is often jokingly re-named to Great Mountains of Paperwork. Whilst the importance of having good quality procedures in place is vital I often see a focus on getting small problems with procedures corrected and then often missing the bigger issue – is the document any good?
What is important is that our procedures are accurate and correct. However I see lots of examples where new versions of procedures are not authorised because of a minor typing error, or typo, such as the word “and” being spelt incorrectly for example. Whilst it is important that procedures are accurate and easy to understand – we do sometimes get obsessed with having them word-perfect. This may not be as important as you might think. Feel free to read the text below – it is full of typos.
“Acconig to a rscheearch at an Elingsh uinervtisy, it deosn’t mttaer in waht oredr the ltteers in a word are, the olny iprmoetnt tihng is taht frist and lsat ltteer is at the rghit pclae.”
Most of you will read this and it will make perfect sense. So perhaps we shouldn’t worry too much about the odd typo in a document if it is not going to cause any problems.
A better area of focus for those reviewing and approving new procedures is to ensure that they actually reflect working practices and are going to be understood by the end-user. Not consulting the end-user in the design and content of documents is one of the main reasons (that I see) as to why documents are either not used AND why so many documentation errors occur.
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
Find out about our course ranges