RPi TrainingFollowing a recent announcement by the MHRA this article highlights the importance of the RPi role after the transition period has finished and the RPi training available from Inspired Pharma
Following a recent announcement by the MHRA this article highlights the importance of the RPi role after the transition period has finished and the RPi training available from Inspired Pharma.
The role of the RPi
From 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the ‘Responsible Person (import) (RPi)’.
The RPi has a number of important responsibilities. These include:
- They need to implement a system to confirm that the required QP certification has taken place for products that have been imported into Great Britain from countries on an approved country for import list (initially, this will be countries in the EEA). The RPi may delegate the activity of checking QP certification has taken place but remains responsible for ensuring the effectiveness of these checks.
- Also, they need to ensure that products imported from a listed country are not the subject of a recall or reported as stolen and are available on the market within the listed country’s licensed supply chain.
- They also need to implement a process to confirm the status of the unique identifier for Prescription Only Medicines
So, this is now a very important role within the UK pharmaceutical industry and clearly organisations will need to recruit and train people to meet this new requirement.
The MHRA announcement highlighted several ways to qualify as an RPi including a Quality Management System Lead Auditor or the Pharmaceutical GMP Lead Auditor qualification awarded by the Chartered Quality Institute.
RPi training courses from Inspired
Our Pharmaceutical GMP Lead Auditor qualification meets this requirement with thousands of delegates attending this course from across the globe over the past 10 years. Find out more by selecting the link in this paragraph.
We also offer a 3-day intensive Responsible Person training course that is aimed at people who want to become a Responsible Person (RP) and is based on and includes the requirements of the Cogent Gold Standard for trainee RPs.
See the full announcement from the MHRA for more details.
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