The Golden Rules of GMP – a free GMP video

This free GMP video is taken from Chapter 2 of our online GMP course – for more details see below.

The free GMP video lasts less than 2 minutes and you can download it for your personal use OR as a part of any refresher/compliance training programme you are running in your organisation providing you leave the opening and closing credits part of the video. To download the video visit our Vimeo site.

More Details about our online GMP course

Our GMP online course is aimed at new starters and existing staff as part of their induction and/or ongoing GMP training. The GMP online course provides a detailed overview of why we have GMP and what GMP is in three CORE chapters with ADDITIONAL chapters covering specific GMP requirements for different parts of the site. Versions available include:

GMP for Manufacturing Personnel
GMP for Packaging Personnel
GMP for Warehousing Personnel
GMP for Laboratory Personnel

The benefits of this approach include:

Access at any time (day or night)
Access via any computer, tablet or iPhone (or equivalent)
Built-in assessment questions and pass-mark
Provides training data for your compliance programme
Materials kept current and up-to-date as legislation changes
No need for an on-site trainer
Short modules with specific topics
Groups can undertake modules relevant to their role
Whether there is a large group to be trained or just a few individuals it is very cost effective
Approved by the Royal Society of Chemistry
Every learner who completes the course can download a Certificate with our logo and the RSC Approved Training logo

For more details about the online GMP course select the blue text in this sentence.

You can see more free videos by visiting our Vimeo site.

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