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Data Integrity has become a ‘hot’ topic

The careful and secure control of data and records has become a hot topic at regulatory inspections recently.  One reason for this is the increased use of computer systems to hold data in one form or another.  That said – data integrity is not just about computerised records.  It is about keeping all records, including paper-based records, safe and secure, accessible and free from damage, alteration and deterioration.  Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.

This is the DDomesday Bookomesday Book, a manuscript recording the “Great Survey” of much of England, completed in 1086 by order of King William the Conqueror.  It was a record of what England was at the time; the cities and towns, populations, number of inns, churches, farms, cows and sheep, etc.  It currently resides in Kew Gardens in London.

In the mid 1980’s, to mark the 900th anniversary of the publication of the Domesday Book the BBC embarked on a grand project to replicated the Domesday Book for the modern world.  Thus started the BBC Domesday Project, involving thousands of school children up and down the country collecting data, photographs and surveys of their own towns to create a new survey of the whole of the United Kingdom.  I was one of these children – who spent many a wet Saturday afternoon taking to people in my home town about that they did for a living, the type of house they lived in, number of children, pets, how they got to work, etc.  In 1986 this was then produced – the finished article.  Two laser discs worth of information – accessible by a BBC Microcomputer.  Amazing!Domesday PC

Now, 30 years later we have a bit of a problem!  As this is the last working BBC Micro in the world that can read the laser discs that the project was saved on.  So after just 30 years the project is (excuse the pun) doomed itself.  It is not that the data is not there, it is that the software and hardware needed to access the data is no longer freely available.  Whereas, still residing in Kew Gardens is the original work, which needs no technology to read it at all.

This is one of the problems with data integrity, especially with regarding to storing data electronically.  We often discard items of equipment when we have finished using them, without realising that the item is essential to read data Domesday PC and Discthat is stored somewhere.  And this continues today.  I have videos at home with no VCR to watch them on, and I have music on LPs and CDs, with no hardware to play them on either.  Now on the grand scheme of things this is not that serious, and a problem can be found.  However, in a regulated environment, such as pharmaceuticals, where the keeping of data for a long time is essential, then do ensure that you that you have the right policies and procedures in place to ensure that critical data is not lost or made inaccessible over time.

Update to post May 2017

New guidance now available on EMA’s website

The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.

EMA’s GMP / Good Distribution Practice (GDP) Inspectors Working Group has developed a set of questions & answers with advice for stakeholders on measures that ensure data integrity and minimise risks at all stages of the data lifecycle in pharmaceutical quality systems. The advice applies to both paper-based and electronic systems. It specifically addresses:

  • assessment of risks to data integrity in the collection, processing and storage of data;
  • risk management measures at various stages of the ‘data lifecycle’;
  • design and control of both electronic and paper-based documentation systems;
  • measures to ensure data integrity for activities contracted out to another company.

The document is aligned with existing GMP guidance published by some regulatory authorities participating in the Pharmaceutical Inspection Co-operation Scheme (PIC/S). It should be read in conjunction with national guidance, medicines legislation and the GMP standards published in Eudralex volume 4.

Also see recent Guidance and Consultation paper from MHRA

If you need any help or support in this area, then please get in touch.  You may also want to consider attending our one-day Data Integrity training course.

TAKE NOTE! We now also have a 20-minute online Data Integrity course designed to bring your team up to speed on this important topic – click here 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 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

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