Does your organisational culture "get" data integrity and it’s importance?

The MHRA’s GXP data integrity guide was published in March 2018. ‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are

Good Clinical Practice,
Good Distribution Practice,
Good Laboratory Practice,
Good Manufacturing Practice and
Good Pharmacovigilance Practice.

As can be seen below, from an extract of the guide, section 3.1 states a clear expectation that ‘the organisational culture’ should ensure data is complete, consistent and accurate in all of it’s forms.

The guide also refers to the acronym ALCOA as the “attributes of data quality that are suitable for regulatory purposes”.

Do the people in your team understand the principles espoused by ALCOA and their role in making sure that your data quality is ‘suitable for regulatory purposes‘?

Have you met this challenge? Or if not, will your organisation be one of the many facing compliance issues on your next MHRA inspection?

We can help. Our 20-minute online course on Data Integrity can help you to meet this challenge. It is affordable for every member of your team and covers these topics:

What is Data Integrity?
Why it is important
The ALCOA principles, for: Paper-based, computer-based and hybrid systems
Application of the ALCOA Principles
The importance of metadata
Positive Quality Culture

And it is approved by the Royal Society of Chemistry.

After successful completion of the course, a certificate with our logo and the RSC Approved Training logo is available for download by the learner and/or your team administrator.

Find out more by clicking on any of the links in this article or here.

The MHRA’s GXP data integrity guide can be read in full by selecting the text in blue.

For anyone needing a more detailed review of this important topic we also offer a one-day course.

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