This is 2020 Blog #3. I made it my business to reread the previous one (ok the truth – I am overwriting – the mother of all bad practices) #2. Written in June, I suppose I was Covid punch drunk and focused on business continuity / disaster recovery plans and shortages. By now we have sort of settled into life with Covid – I don’t leave the house without a face mask… unless I forget. I have a CAPA on that too – masks in every bag, briefcase, pocket…
In earlier blogs I had said we need to define the purpose of a quality system. GMPs are NOT a quality system and never were intended to be one. They are a series of requirements. If quality is “Meeting all the requirements all the time” we need to do a better job of defining requirements. I have done a little better on defining what a foundational quality system is – with the help of ISO9001:2015…another of my grumpy cats.
The ISO standard makes the crucial point under the section Risk Based Thinking: “One of the key purposes of a quality management system is to act as a preventive tool” and this is where the GMPs, industry and regulators have
colluded over the years to ensure failure.
What is this collusion? It is that nasty little part of the GMPS which accepts deviations as an essential part of what we do.
It is true the EU GMPs advise us to avoid deviations as much as possible, unlike 21CFR part 100 which with no such qualifying statement
says: “Any deviation from the written procedures shall be recorded and justified” or in other words 'there will always be deviations, let’s accept that as an unavoidable fact of life and just document them and JUSTIFY them!!!'
The GMPs MUST be revised and must remove / replace this statement. #PREVENT is my new movement to switch pharma from reactive to proactive mode. Deviations should not be accepted as an unavoidable fact of life. Risk based thinking and control strategies are about analyzing and MANAGING PROCESSES. Any process is amenable to this – as long as we map it out and spend time on #PLAN – developing a robust process where we didn’t say “ah it’ll be ok – and if there are deviations – well the GMP allow us to mop up.” Then with the wisdom of King Solomon, those incredibly smart QA Directors write a “risk assessment” and release the DEVIATING product. Human error, so let it happen again… and again… and again…
Once a deviation has happened and you are trying to justify releasing NON-CONFORMING product, this is NOT RISK BASED THINKING. It is RISK-TAKING which is a completely different kettle of fish (in this case stinking fish!) At the very least can regulators (calling out PIC/s here as I believe it started with them) STOP asking for a risk assessment which should be proactive and #PREVENT and call it what it is – a product impact assessment. Gosh – even for me… what a RANT! (Karen stop shouting – all those capital letters). Of course that’s the beauty of a blog – you can run with it and let it do whatever it wants.
Some conclusions then:
One of the primary purposes of a QMS is to #PREVENT bad things from happening, by using risk based thinking, by #PLAN, DO, CHECK, ACT = control strategy per process.
A MATURE quality system #PREVENTs!
GMP conformance CAN be integrated and the system still be effective but we should be aware that releasing ANY batch with an associated deviation is a sad and essentially bad thing to do. Sometimes, in order to avoid a genuine shortage which is a greater evil for the patient, we may HAVE to release a non-conforming batch. That may on rare occasions, be the right thing to do (they are not currently rare). NEVER should we deceive ourselves into believing that this is the preferred or default state. We do it only after the system failed to #PREVENT.
What other stumbling blocks have industry AND regulator placed in the way of an effective and foundational quality system?
In the previous blog I included two updates:
(i) ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
(ii) PIC/s draft guidance: How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management
These documents, which apparently are much needed, are nevertheless new and additional hurdles and therefore stumbling blocks for industry. FDA has been talking of a vision of an agile manufacturing organization – can we ever be agile if implementing changes requires ICHQ12 and the PIC/s draft guidance? I mean how many changes have you had to make in your QMS as a result of Covid. Plexiglass barriers to enforce distancing in offices and manufacturing and laboratory areas is just one part of it? Masks, staggered working hours, other? Did that go through the change control process and how long did it take and how well was it documented and controlled? I hope it was fast!
My vision for 2020 was to implement P-D-C-A for myself:
Every action that is taken during 2020 and thereafter, will be considered and planned. (P-D-C-A) Implementation will be according to what was planned OR, if what was planned turns out not to be the requirements, then the requirements will be officially changed, people who need to know will be notified and the action will be planned all over again prior to implementation.
As of August, we (my husband and I and my mother) had to move out of our homes (Plan: we sold them and bought in another city), and as our new places weren’t ready, we had to rent a furnished place. We are all together for now, because we are a “Covid Bubble group” – so all the careful planning which left several spare months for completion of our project – failed! We did move, but are rather stuck living out of suitcases with 95% of our belongings in storage. But we are ok and well as I hope all of you reading this are too.
More importantly – we are thank G-d all well. I pray that the people I know and those each of you know who are currently battling Covid, will make it through. Those of us who are healthy are blessed – whatever the restrictions. Let us acknowledge it and in appreciation do a kind deed for a neighbour or friend, or phone someone who lives alone. People are soooo lonely.
My best wishes to anyone reading this and remember…
# PREVENT – WEAR YOUR MASK WHENEVER YOU GO OUT – please… and stay safe.
Karen
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