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 Martin
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
To see all of the articles on Annex 1 2022 select the button below:
The original objectives for the update of annex 1 included the need to incorporate risk management in the manufacture of sterile products, to address the advances in technology for clean spaces, increased use of closed and single use systems and to address a number of historical ambiguities and inaccuracies.
So what are the main changes?
The 2008 version of Annex 1 covers 16 pages and a total of 127 clauses while the new version now covers 58 pages and 294 clauses. In essence all the old clauses are still there even if in some cases slightly reworded. In the most part many have been added to provide clarity. There are also many new clauses.
The new annex 1 has a new structure covering 10 sections and a glossary.
Annex 1 Structure
As well as explicit requirements on risk management perhaps the subject creating the greatest amount of interest is that of a contamination control strategy.
This and many of the new and updated concepts will be reviewed and discussed in forthcoming articles. However, for now let’s just say that underlying the requirements in annex 1 is having the appropriate knowledge and competencies within the organisation. These are and will continue to be essential for keeping up to date, to performing robust, professional, and responsible risk assessments and in the development of the contamination control strategy. Ultimately, this enhancement of knowledge management should be better for patient.
About the author
Andy Martin
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.
