Quality & the Life Sciences supply chain: what to expect in 2023

Author Company: REPHINE

Author Name: Dr. Eduard Cayón, VP of Audit Services

Editor: PharmiWeb Editor 

Summary

After practical supply chain issues in 2022, added to the impact of continued medicinal/device innovation, 2023 will bring new regulatory changes linked to process digitalisation and automation. REPHINE’s Dr. Eduard Cayón discusses the implications for Quality control.

Never before has the Life Sciences industry needed a robust manufacturing and supply chain Quality backbone as it does now.

Advanced markets such as Europe and North America are already well used to strict controls and audits, but standards are being raised right around the world now - from South America to the Middle East and Asia. The pandemic, the war in Ukraine, and innovation-based disruption at the core of the industry have contributed to a renewed focus on supply chain security and quality. The upshot is that manufacturers must be able to vouch for every aspect of the product manufacture and delivery lifecycle, wherever the different touchpoints are, with GxP standards (recognised good manufacturing/distribution practices) as their framework and guide.

Staying abreast of all of the requirements, and maximising opportunities, requires that Life Sciences companies are agile - both in resolving immediate problems and adapting to changes that arise as the regulatory environment continues to evolve and modernise. Companies must be confident of leaving no gaps in their level of GMP compliance.

COVID-19 has left its market

Aside from the direct impact on production lines and supply chains, the pandemic has left a legacy in the form of new channels and formats for auditing, most notably increased use of remote methodologies for at least

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