GDP and GMP TrainingOur range of highly interactive and thought provoking GDP and GMP training courses are available in the classroom, for your experts, and online for your organisation.
GDP and GMP Training – Classroom courses for your experts and online courses for your organisation
Whatever your GMP and GDP training needs are, Inspired Pharma have the right solution for you. We offer a series of public classroom courses that run on a 6 monthly basis, at least, and often more regularly. These courses are also available for in-house delivery and can be tailored to meet your exact needs.
In addition, we have developed a range of online GDP and GMP training courses which can be deployed for
- a GDP or a GMP compliance training programme
- a GDP or a GMP refresher training programme
- or used as part of a GDP or a GMP induction training programme
These online GMP and GDP training courses can also be complemented with workshop activities designed and delivered by Inspired Pharma experts to maximise the impact of any of these programmes.
Our expertise is second to none and we have delivered GMP training to many of the top global Pharma organisations.
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