Express Pharma as part of SAP India’s Industry Knowledge Exchange Forum’s Expert Speak series, invited pharma quality veteran Dr Ranjana Pathak, President, Global Quality, Medical Affairs and Pharmacovigilance, Cipla to discuss how companies are proactively preparing for new modes of business like virtual inspections, and other ‘business-as-unusual’ practices. Pharma technology expert Rajesh Kuppuswamy was also part of the discussion
As the COVID-19 pandemic forced pharma companies and regulators to think out of the box, industry leaders today have advanced tools powered by AI and ML tools to help them comply with quality norms.
However, experts also realised that without the “why”, employees might not truly understand, and imbibe, the relevance of concepts like quality excellence, data integrity etc. Making these concepts part of the mindset of every employee, not just the quality department, is therefore mission-critical to increase compliance levels and achieve quality excellence.
“Quality is a mindset, not a department,” emphasises Dr Ranjana Pathak, President, Global Quality, Medical Affairs and Pharmacovigilance, Cipla during a recent Industry Knowledge Exchange Forum. Her mantra calls for designing procedures in such a way that everyone in all functions, from HR, R&D, supply chain, to the housekeeping staff, understand the relevance of quality and more importantly, the consequences of actions like “switching off the audit trail for two minutes.”
And rather than waiting for regulators to set quality compliance norms, she believes that “we know more (about our operations) than the regulator” and should therefore be ahead of the curve and proactively work at having “smart quality management systems”. Catching and solving problems proactively before they occur, literally “fixing the roof while the sun is shining” as Dr Pathak puts it, is much less expensive.
That sounds logical, especially as the reputational loss due to poor quality management systems is tougher to shake off than thinning profit margins.
The cost of non-compliance
Unfortunately, the cost of non-compliance is borne not just by the erring company. Regulators and the public at large start to lose faith in the sector and re-building that trust is almost impossible.
So, it’s not enough that a few larger companies like Cipla and peers are seen as proven quality champions; achieving quality excellence has to become vital for every company in the sector.
Fortunately, we now seem to have the technology tools to help companies up their quality game. Whether it is Dr Pathak piloting a quality control (QC) capacity planning tool across six factories which is “significantly enhancing the productivity” of Cipla’s QC lab network or Rajesh Kuppuswamy, Life Sciences and Health Care Industry Advisor, SAP India helping Indian pharma clients identify parameters for “golden batches.”
Indian companies should thus feel more confident of charting unknown territories like biosimilars, as such technologies would help them identify weak spots to prevent early missteps, thus conserving scarce resources.
Unfortunately, Kuppuswamy’s experience is that not all companies are willing to believe in and invest in such technological solutions for a variety of reasons, not always cost-related.
For instance, one objection to quality intervention checks, manual or technology based, is that more checks and balances will decrease efficiency and productivity of the process, whereas Kuppuswamy reasons that it is actually completely the other way around.
Perhaps the greatest incentive to investing in quality is to consider it a competitive differentiator, especially during challenging times.
Dr Pathak goes a step further, pointing out that if a company was not successful on quality parameters during normal times, achieving success during tough times would be even more challenging.
For example, having been through three virtual inspections during the pandemic, she discusses why they are tougher than onsite inspections. “To be successful in a virtual audit we should have been successful every day, because unfortunately there’s no quick and easy methodology with what we do, there are no easy wins.”
As Kuppuswamy puts it, while technologies from companies like SAP can take care of expanding the capabilities of the workforce and the capacities of companies to support their growth plans, it can never change the intent of individual employees.
And that is where initiatives like Cipla’s Go Fearless campaign comes in. As Dr Pathak puts it, the programme empowers employees to own up to their mistakes, “If you’ve dropped coffee on the record batch today, raise your hand.” “Fostering that environment” is a step in the right direction and bodes well for the sector.
To sum up, the panellists agreed that while companies allocate budgets for high tech, it is equally if not more important, to first inculcate the right mindset that quality is not cost of compliance, instead it is a competitive differentiator. This then translates into an intent, which can be enabled by technology. The other frontiers for quality excellence will automatically fall in place. Those who are not able to bring this change will be forced to accept the change or be left behind.
This is excellent, as a right balance between people processes and technology is the key. Finally if we can create the compliance as culture rather than regulators enforcement, is the key differentiator.