For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 info@inspiredpharma.com

We are pleased to announce that following a close partnership with one of our clients we now have available a one-hour on-line course designed to provide people new to the pharmaceutical industry with an appreciation of the main requirements of Good Distribution Practice. 

It can also be used as part of on-going refresher or compliance training for people with experience of working to GDP. The course can be customised and also accessed via your own internal systems, if required.

The course has four chapters including:

  • an introduction to the pharmaceutical industry
  • an introduction to Good Distribution Practice
  • an overview of The Good Distribution Practice guidelines
  • an overview of the key elements of working to GDP

The cost is £95 for an individual booking with substantial discounts available for multi-person bookings. For full details of the course click here.

Or complete the details in the panel below to try out a sample of this course.

If you have any queries on this initiative or any of our other services then please get in touch.

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 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

Related Articles

Find out about our course ranges

GMP Training

 

QMS Training

 

GDP/RP Training

 

GMP Compliance

 

QP Training

 

GDP Compliance

 

Free Taster courses

To try a free taster of our online courses to see if they are of interest visit this page.