Occasionally it seems that waves sweep over the pharma industry and everyone you talk to has wet shoes, or a mate with wet shoes, or a story of someone who's shoes were so wet they ended up sacked or jailed.
The MHRA, like the Admiralty Office, publishes a 'table', telling us when the regulatory tide will be coming in and just how deep the water will be!! This year’s spring tide is 'Data Integrity'. Data Integrity is ‘the talk of the steamie’: the industry magazines are writing about it, the pharma trainers are running courses on it, we hear that MHRA inspectors are looking for it (you can almost hear John Williams' classic soundtrack in the background!), and we tell the stories of groups who failed 'data integrity'.
So what is Data Integrity?
The ideas behind ‘data integrity’ are defined in the new Data Integrity Guidelinesand relate to computer systems and how pharma uses them to control processes or generate accurate results. Computers are powerful and sophisticated tools that help with pharmaceutical production, but are often built and programmed by people who don't understand pharmaceutical quality. Just think about those frustrating days when your computer or phone crashes and you lose your last few hours work, your contact list, or your game level, and how that sort of bug on a manufacturing line would affect medicines intended for patients. One of my former colleagues from about 20 years ago had a funny story about one facility he heard of where hooky versions of Doom had been installed on the networked PCs, which became so popular with staff after-hours that the bandwidth couldn’t cope and skipped realtime data from the lab’s testing equipment!
Back to the Future
So why, 20 years later, are the Data Integrity Guidelines coming in and washing away our sand castles? The 'street talk' is that they are coming in now, not because covert Black Ops gaming sessions are compromising quality, but because some companies have been found manipulating, falsifying or otherwise ‘pockling’ data. I can’t find any website or publication that is prepared to state the new Guidelines have come out because of fraud, so perhaps it’s just ‘tearoom chat’. (Although the author of this article in Pharmaceutical Technology must use our kitchen too!).
During a recent audit of our lab systems I was asked questions about ‘selecting’ data and running undeclared ‘pre-testing’ on test samples. At the time they seemed like weird questions (because they seemed to me to fly in the face of a 'proper' analytical process) but with hindsight I think if the auditor was trying to work out if I operated in an environment where the focus of my lab tests was to obtaining data to 'confirm the required result’ and not actually 'measure the right one’.
Root cause and driversI've blogged in the past about the driving forces of the pharmaceutical industry, how cost 'drivers' give cheap products, but not necessarily quality ones: and how the dangerous concoction this makes when mixed with large-scale purchasing arrangements where the buyer - who is not the patient or consumer - also works to cost drivers.The focus of pharmaceutical regulation is that manufacturers needs to make sure they’re using the right equipment, in the right way, to get the right result. The Data Integrity Guidelines form part of the framework that helps those involved in pharmaceutical production do the 'right' thing.But do they go far enough? One of the most thought-provoking conversations I had last week was whether ‘we’ (the pharma industry and the regulators) have really got to 'root cause' on this one: the new rules are about Data Integrity, but is the real issue Cultural Integrity?
Integrity GuidelinesThe word integrity has a few different meanings. In the context of the new regulations it means 'whole or complete', but the word also means 'moral or honest'. I wonder if the regulators have deliberately titled the new guidelines with a ‘double meaning’. Either way, last week’s discussion focussed around the idea that Data Integrity needed Cultural Integrity: measurements and processes that are ‘whole and complete’ can only come from a culture that is ‘moral and honest’.
An organisation with Cultural Integrity (ie moral and honest) will use the Data Integrity Guidelines to plug any loopholes in their processes so that their Data is Integral (ie whole and complete) and they 'get' or measure the 'right answer'. Organisations without Cultural Integrity will use the Data Integrity Guidelines to find the loopholes they can still use so that they can claim the data is integral but keep on producing the 'required answer' their culture demands.
I’m struck by the difference emphasis given to integrity (as morality and honesty) by the pharmaceutical regulations as compared to professional bodies. The Royal Society of Chemisty requires that I, as a Charted Chemist, “Demonstrate reliability, integrity and respect for confidentiality on work related and personal matters”. Similarly, pharmacists and pharmacy technicians are required to “Be honest and trustworthy”. The closest the GMP guidelines get to this is this statement in the Eudralex: “The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience” (Eudralex, Volume 4, Part 1, Chapter 2: Personnel, para 2.1). Not quite the same.
It appears that honesty and integrity are required for membership of a 'learned society', but not to produce pharmaceuticals! To be fair, I doubt that many professional bodies actually check that their members are honest, trustworthy and 'personally reliable', but the absence (even a brief one) of a similar standard of conduct in the GMP manufacturing guidelines does seem a bit stark. I'm not sure that the pharmaceutical regulatory agencies will be publishing 'Cultural Integrity Guidelines' in the near future (although it'd be interesting to get an insight into how good manufacturers develop and maintain a proper 'integral culture'), but a sentence in the Eudralex might be a good place to start!