Inspired Expanding Overseas

Wishing everyone a wonderful 2019!

2018 saw an increasing number of overseas delegates attending our UK and Ireland public course programme. We also conducted a number of consultancy assigments in the US and the Far East as well as delivering many onsite courses to overseas subsidiaries of our UK pharma clients. And we succesfully delivered our 5-day Pharmaceutical GMP Auditor / Lead Auditor course in Japan.

So, we are excited that this new year takes us to new shores, as we also now plan to export our expertise to the Middle East and India.

Having seen considerable interest in our training courses we are now looking to hold public courses in Dubai and Mumbai later this year. Dubai is the dynamic, commercial hub of the UAE and the gateway to a region where the pharma economy is expected to reach $38 Billion by 2021. Mumbai is the financial and commercial capital of India, which boasts one of the world’s fastest growing economies, where the pharmaceutical industry ranks 3rd world-wide, in terms of volume.

Helping us with this expansion is Ravi Mirchandani, an International Business Development specialist who has over 30 years’ experience in the ISMEA region.

We are also finalising a new hotel venue in central London, to facilitate easy access for our overseas delegates. Our first event is the 5-day Pharmaceutical GMP Auditor / Lead Auditor course from 13^th May to 17^th of May 2019. This venue is also available to UK delegates who may prefer Central London to our Reading option.

Details on this course can be found here or feel free to contact us for further details or to discuss your specific needs in more detail.

Dominic

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.

More details