Karen Ginsbury’s Quality Blog #5 (2022/#1)

January 25, 2022

Back to the Future: Can Pharma have an Effective QMS?

Welcome to… 2022. I only managed one blog in 2021 compared to three in 2020 when Covid was new to us. I am not surprised as we moved twice – once in 2020 and again to permanent new home in Jerusalem in early 2021. My mother moved with us – now next door – so there was a lot to navigate in maintaining and recalibrating our Quality Management Systems!!

I see that in the previous blog, I over-optimistically wrote that Israel was almost done with masks. I was on a plane as I am now. The difference is that today I am DOUBLE-MASKED as a risk mitigating measure against the yet more infective Omicron. If I don’t test negative on arrival, I won’t be able to visit my sick father and that’s the entire purpose of the trip – so risk management is focusing on prevention rather than detection. I believe masks are effective when worn correctly.

I will continue to remind you that…

One of the key purposes of a quality management system is to act as a preventive tool”

Covid vaccines were in the last blog, and after three doses, it is clear to all that they do NOT #PREVENT Covid. What they seem to do is to reduce the severity of the disease and even that is open to question. Having had three doses, and my husband and mum after FOUR, one has to ask – how much of this stuff will we put in our bodies and why, if my 4 x vaccinated friends are getting Covid anyway.

I’m coming back to prevention and what makes an effective QMS in a moment. In the last blog I told you I was coming to terms with our i-robot for cleaning the new flat. Here is my report – entirely satisfactory – cleans far better than myself or my husband, is exceedingly thorough and set-up not overly laborious. However, I am not e-competent – operation is by husband. My motto is “need to know basis” – so as he can and does do it – I don’t need to. We have also installed a smart thermostat on the water heater, so that we can operate it at different times each day from outside the house and have boiling hot water at max efficiency any time there isn’t enough solar power to provide it free! Why am I sharing all this – because in the move to INDUSTRY 4.0 all of your companies should have a vision for eliminating the human element, where possible. Robots are reliable, don’t think and don’t make mistakes – they can break down but people get sick and leave. Competency is not an issue with a robot or smart system.

And now back to the QMS issue. Continuing my previous blog / rant regarding the PQS or “Pharmaceutical” Quality System and its focus on correcting bad things as they happen rather than prevention. I do really want to clarify – because in a course I am giving on CAPA I said a QMS is

useless if it only corrects and doesn’t prevent. A very wise and attentive student (I always get those at IFF – this one was online in Israel), called me out and asked if the system isn’t of use if it catches bad stuff. To which I replied, thanking him for reminding me of the dangers of using absolutes like “useless.” I have CAPA’d that statement, deleting “useless” and now it comes out like this:

A QMS is truly effective particularly from the cost aspect but also ensuring uninterrupted supply of quality product, when it #PREVENTS bad things from happening rather than just reacting and fixing them after they occur. It is still FAR better to catch them, especially in-house and fix them, then to have no system at all and the defects get out and harm a patient.

And now back to the rant – back to the future – have you seen…

THE DRAFT REVISION OF ICHQ9 R1? Issued in December 2021 Quality Risk Management. I haven’t read it cover to cover and haven’t yet submitted comments – I BEG OF YOU and your companies to do so. IFF committee – let’s work together and submit comments – maybe set up a Zoom to review it? Actually I am planning a short webinar on it at end of Feb early March. I’ll give Christina a heads-up so you can register early as participation is limited and it is FREE. This revision was supposed to be the BIG ONE – after 15 years (2006), a revision which will “shake up industry” and make QRM effective. Yet, when you read the introduction, the FIRST use of QRM discussed is to REACT to deviations and product / process non-conformities. Woe unto us, if the wording remains as proposed in lines 26 and 27 “ an effective QRM approach can further ensure the high quality of a drug product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing.”

Can “further ensure” “high” quality?

“further ensure” implies a secondary benefit. Proactive means should be PRIMARY – ISO9001:2015 – the purpose of an effective QMS is to act as a PREVENTIVE TOOL.”

And “high” quality? NO – QUALITY is meeting all the requirements all the time and failure to do so means there isn’t quality. Philip Crosby in Quality is Free tells us that we cheapen the term Quality by referring to “high” or “low” quality. At least let’s ask the ICH to make PROACTIVITY of the QMS a PRIMARY purpose and reaction such as prevention of shortages after we messed up and (better than missing it) react – a second and less beneficial purpose of QRM.

SO if this blog makes you read the draft, and if, even better makes your company comment, we will have made progress to a more effective QMS and a step away from the “PQS.”

I hope to see you all once again very soon and send you my very best wishes. I did see a lot of you last August when I managed to sneak in and out of Denmark during a Covid valley – hope to do so again this year.

Please… stay safe.