New waves of innovation in Life Sciences, and a redoubled effort by regulators around the world to maintain the highest standards of safety, are placing increased pressure on drug and device manufacturers to assure the consistent standards of their manufacturing processes, systems and supply-chain partnerships. During 2022, a number of important trends emerged or deepened, which are having a significant impact on the sector – ranging from practical supply chain issues to medicinal/device innovation. 2023 is set to be another milestone year, with more regulatory changes afoot linked to process digitalisation and automation. REPHINE’s Dr. Eduard Cayón sets out the key Quality considerations global LS manufacturers need to be on top of.
If ever the Life Sciences industry needed a robust manufacturing and supply chain Quality backbone, it is now. The reinvention of medicine continues apace, global supply chains are being restructured, and regulators are extending their controls over critical processes in digitalised and automated form.
Change and the need for consistency, fluidity and predictability mean that manufacturers need reliable controls and proof of their attention to detail. Even as they go deeper with digital transformation, they must consider the IT systems and automation tools they are harnessing, designing in quality from the outset and ensuring that everything is validated and will stand up to the scrutiny of an audit inspection.
There’s a lot to unpack, but success starts with awareness and a plan.
Disruption is Everywhere
As a result of the pandemic, and further aggravated by the war situation in Europe, the problem of shortages of some medicines persisted in 2022. The continued/repeat closure of China and the difficulties in the supply of raw materials presented a major problem, forcing pharma companies to rethink their reliance on far-flung markets for APIs and other raw materials. To ensure supply security, manufacturers have had to review their sourcing options and, in many cases, opt for alternatives closer to home – despite the associated expense. This activity continues and with it the need to review the quality performance and compliance records of new suppliers or alternative manufacturing sites in Europe or North America.
At a more strategic level, we’re seeing a whole raft of innovations and new medicines focused on macromolecules from biotech processes, or adaptation of existing medicines through the addition of medical devices and/or app-based digital controls and data exchanges. As the regulatory environment strives to adapt its quality and safety requirements, parameters for compliance are becoming stricter and more all-encompassing, putting pressure on manufacturers to keep updating their controls and monitoring more of their activity. We are seeing new harmonised standards and guidelines being published all the time, whose changes are based on the need for better scientific and technical knowledge of the processes, as well as risk-based management.
