I recently had the honour to be invited to speak at the PDA India’s annual conference in Hyderabad. The event was well supported by the local India office of FDA in person and senior FDA personnel (including Carmela Rosa and Jose Melendez amongst others) virtually. It was great to see the FDA continue to support events like this to help the industry grow.  

The meeting had some great presentations and discussions. Day 1 was focused on regulatory feedback and some of the great work that PDA is doing to support the industry. Day 2 was focused on interpretation of regulations, data integrity and cleaning, including a great presentation from Lachman’s own Scott Deckebach on data integrity and AI.  

Day 3 focused on aseptic manufacturing with a focus on smoke studies, with a fantastic live demonstration of what a smoke study should look like (and what it should not look like!).  

On Day 2, I presented on interpretation of regulations. There was a lot of discussion addressing the question: Can the regulators tell us exactly what to do? This reminded me of when I was chairing the Annex 1 (EU GMP Vol IV) rewrite. After the first public consultation, we received over 6000 comments, but there were two clear subgroups that came out during the review. These were exemplified by the following statements: 

    1. “This document is too prescriptive, we are a mature industry and do not need this level of guidance.” 
    2. And of course, the second subgroup stating, “this document does not have enough detail and needs to be more prescriptive.” 

 

It surprised me that, in this day and age of Quality Risk Management (QRM), that we, as an industry, have not fully embraced this. The regulators are giving us the freedom to tell them what we do and why.  

As I spoke about the interpretation of regulations, I used an anecdote from many years ago when Chapter 1 of GMP (regarding Quality Systems) was updated to include reference to the use of QRM principles. One of my ex-colleagues from the MHRA led the working group and I saw him present on the updated document. During the presentation he stopped and looked thoughtful for a moment and then said something along the lines of: “Of course, if we really embraced the principles of QRM, the guidelines would be one paragraph ‘Don’t do anything stupid!’”. Then he stopped and thought for a moment more, and then said, “Well, perhaps it would be two paragraphs…Para 1, ‘Don’t do anything stupid’, and Para 2, ‘if you really must do something stupid, don’t do it again!’” 

That sentiment really rings true with me, especially as today we see repeat issues such as DEG/EG and contaminated products that are long standing observations from decades ago and we are still asking the regulator to tell us what to do.  

So, what does a firm need to do to really embrace QRM? Well, there are a number of critical key elements: 

    1. You need to have the support of the senior management team, “leadership from top down, but empowerment from bottom up.” 
    2. You need people with the right attitude – they really need to know not just the “How” but also the “Why”; this also came up repeatedly at the PDA India Annual Meeting. The “Why” means not only “this is how you do it” but also, this is “Why”; e.g., there is a patient in need of a medication at the end of our supply chain for every product and if we get it wrong, their lives may be put at risk. 
    3. We need to perform open and honest risk assessments to underpin our decisions; too often assessments are based on a pre-determined outcome, rather than being an unbiased conclusion. 
    4. We also need to have the correct technical knowledge and “company memory”. How many of you have been in discussions during investigations where somebody from the shopfloor “pipes up” and says, “we had the same problem 10 years ago” and invariably, they also have the solution, which everybody else had forgotten.  
    5. We need to have good knowledge management processes to ensure the transfer of knowledge, especially as we see more experienced personnel leaving and taking their hard-won knowledge with them. 

 

In my opinion, these are key to QRM principles. With regards to adequate technical knowledge, one of my other colleagues from the MHRA used to say, “If I know more about your process than you do, then there is a problem.” Unfortunately, we frequently did know more! 

So, for me, I think we as an industry need to stop asking the regulator to tell us exactly what to do and embrace knowledge and science and tell the regulator what we do, and why we do it, with a focus on our ultimate objective of patient health.  

The regulator has asked us to embrace QRM, but I would give this note of caution; as stated by Voltaire (and I believe Spiderman as well): “With great power comes great responsibility.”  

Lachman has many technically gifted people on staff who have great regulatory experience (many of them are ex-regulators from a number of different authorities) and have practical advice for firms regarding QRM. Reach out to us today for a consultation at LCS@LachmanConsultants.com.