Karen Ginsbury’s Quality Blog #2

Well, Well, (not so) Well!

Welcome to 2020 Blog #2.  I just reread #1.  Written at the beginning of January it talked about visual acuity… and mature quality management systems, using technology, statistical process control and planning to ensure a reliable supply of drugs manufactured at each facility.  How certain I was that 2020 would carry on just like 2019… more of the same sprinkled with a  little improvement here and there…

Who had heard of Covid-19 in early January.  Like so many others, I had trips scheduled around the world for the rest of the year, and was busy doing what I do.  We heard of drug shortages and yet, even with the congressional report identifying logistical and regulatory challenges as making it difficult to recover after a supply chain disruption… were any of your company’s Covid ready?
Any of you got business continuity / disaster recovery plans which address pandemics? (I wonder how many of you have such plans in place at all – never mind addressing pandemics…).  As we gradually emerge from lockdown what kind of shortages are we likely to encounter?  Starting materials, components, or down to the basics… toilet paper for employees, eggs and flour for the canteen? Over 60’s not allowed out and our workforce doing the shopping for them? Social distancing thinning out the production lines?  SHORTAGES of FACEMASKs and cleanroom clothing because you and I know that the Covid 19 suits are Tyvek™ and if the world is short on those for ICU staff… pharma will be rather low on the list of those who can purchase them.

Oh where to start? Risk mitigation – will regulators allow relaxing of some accepted industry practice in lower grade areas?  Will those of us who routinely used face masks in grade D or C areas reconsider at least as a temporary measure?  Can we rethink “over-design” of clothing.  What about gloving practices?  Double gloving?  TRIPLE gloving?  We may find ourselves lucky to be able to allow one pair per entry for sterile gloves and may need to consider using non-sterile under gloves…IF, we can purchase those at all.  I may just add, that for the past month, no (non sterile) latex gloves, powdered or not, have been available in the stores in Israel where they were a standard item.  I understand there is a global shortage.

Remember Question #2 in the first blog of the year? How close is your Quality System to perfection?  No quality system is perfect – pharmaceutical or other.  Nor is this the desired state since it hinders continuous improvement and progress.  What we need is 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 had promised in blog #1 to investigate what a foundational quality system is and if CGMP conformance can be integrated and the system still be effective?  I said I would consider the stumbling blocks which industry AND regulator have, and continue to place in the way of just such a system and ask why other industries, of no less criticality than pharma manage to implement foundational quality systems.

I included two teasers and updates:

  • ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • PIC/s draft guidance: How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management

The teaser was why these documents are both grumpy and happy cats.

I wonder if you came up with your own answers? If so, please write in to IFF and share.

My answer: particularly the PIC/s document – very detailed, micro guidance that will require almost every pharma company to revisit and rewrite their change control policies as well as confusing change control with change management (a different blog topic).  There’s the grump!  On the other hand, the points raised make a GREAT checklist for helping to avoid disasters associated with change.  ICH Q12 – another document another guidance another distraction from the overall picture, another add-on to the existing system rather than an integrated and PROCESS-driven system.  There’s the grump.  BUT, the happy cat: enough of the prayer model – validation, three batches, filed in the archive for the mice to gnaw for 30 years and OOS batches are ok because the process is validated.  NO! the process must work – and lifecycle management acknowledges and plans and integrates changes over the lifecycle constantly checking – remember Plan -Do – Check- Act.

I will end by reminding myself and you of my vision for 2020

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.

Covid has given us all a bit of a laugh at that – considered and planned?  We didn’t plan a pandemic, we didn’t plan lockdown and I hope and pray that you and your loved ones are safe.  Right now, the only considerations and planning we can do are in line with the instructions we get from our governments.  Many of us are working remotely, doing what we were doing before and with a little more (or strangely without flights and car / bicycle trips) or less time on our hands.  We will need to put recovery plans in place, address lapses in the quality system through massive, government -mandated absenteeism and do the very best we can to ensure uninterrupted supply of life-saving therapies to patients.  May we succeed.