Importantly, this resulted in a reduction of onsite inspections and an increase on the reliance of self-assessment, robust compliance monitoring, risk management and, critically, greater levels of trust and co-operation.
With the fallout from the pandemic and the multitude of studies, guidance and management tools now available — including QMM, outcome based co-operative regulation, cultural excellence, quality culture and climate, and sustainability — are we experiencing a new era in pharma regulation?
To find out more, I spoke to Sam Atkinson, Executive Vice President at NSF, about her perspectives on regulatory evolution and NSF’s new quality management maturity (QMM) assessment tool.
Sam was previously the Chief Quality and Access Officer at the MHRA and had worked within the UK regulatory system for almost 17 years. Needless to say, Sam has a wealth of first-hand experience and is a seasoned traveller along the path towards regulatory progression.
I asked Sam about her career history at the MHRA. “It was a fantastic experience,” she says: “I was working with incredibly talented people across the globe, influencing regulatory approaches and, ultimately, working to improve the supply of safe and effective medicines for patients.”
“What’s interesting is how, with time, both the regulatory bodies and industry have adapted. The commitment and dedication to improving what we do for patients has been evident and is the driving force that ensures that the sector remains at the top of its game.”
I suggested that the pandemic may have had a fair bit to do with the evolution of regulatory and digital approaches. “Indeed, we had to act rapidly. Every sector was in the same position. Transformation that would normally take years was done in weeks and months. The balance of risk had changed and our ability to operate in the same way was no longer possible.”
So where have things moved to now? “Some of the positive changes that were implemented during the pandemic have been kept in part or full, whereas other regulatory flexibilities have been removed now that the risk has changed. While we responded to the coronavirus threat, there was a need for organisations to take greater levels of accountability of their regulatory responsibilities.”
“Onsite inspections (almost) ground to a halt as virtual monitoring took over. The regulators required greater levels of evidence of internal oversight and self-assessment — putting greater levels of trust in the industry.”
“This aligns with many of the new approaches that we’re seeing today. Historically, regulators shone a bright spotlight on data integrity issues following a number of data quality or fraud incidents. There is now a greater level of focus on co-operative regulation, whereby each party within the regulated space takes ownership of maintaining compliance."
"This requires an optimised culture or climate to be maintained within the organisation — one in which quality is embedded and is understood by every part of the company.”
“More recent research and activity has focused on QMM as an integral factor in supply chain robustness. Indeed, a 2019 US Federal Drug Shortages Task Force report concluded that 62% of shortages between 2013 and 2017 were attributed to manufacturing or product quality problems.”
I was curious to hear about NSF’s QMM Assessment Tool. “The NSF model has been designed to align with and reflect the FDA’s findings regarding the Center for Drug Evaluation and Research (CDER)’s assessment process; but, importantly, it also takes into consideration other research on the impact of culture on the (quality) organisation (such as the ISPE APQ Guide: Cultural Excellence).”
“Historically the dichotomy between quality and business objectives has shaped a company’s operational activities. QMM, however, ensures a cohesive approach that blends together a mature quality culture, technical processes and corporate-wide business approaches.”
“The quality organisation is assessed according to three pillars — strategic, tactical and operational — that each contain a number of assessment areas. These can be customised to meet the needs of a specific assessment. The current maturity level is provided, along with recommendations and a target maturity level.” Some of the benefits are that
- it examines the robustness and effectiveness of the Pharmaceutical Quality System (PQS) and looks beyond the immediate environment
- it supports a positive culture climate that encourages openness, trust and learning, leading to fewer deficiencies or excursions and resulting in fewer non-compliances or recalls
- it future-proofs the organisation, supporting proactive continuous improvement and sustainable compliance management
- it’s flexible; the model can be used to undertake an organisational/site health check or consider PQS maturity improvements.
In conclusion Sam adds: “To achieve success, senior leaders must be open to the benefits of tools such as NSF’s QMM Assessment. Recognising the opportunity and taking the first step could result in a cascade of long-term benefits, a more resilient organisation and a drug supply that’s both sustainable and secure.”
Keen to know more? Don't miss Sam's presentation on this topic at the upcoming Manufacturing Chemist LIVE event.
