2023 will bring new regulatory changes linked to process digitalisation and automation, REPHINE’s Dr. Eduard Cayón discusses the implications for quality control and how pharma companies can stay ahead of the curve.
Key insights:
- Life sciences companies should be agile - both in resolving immediate problems and adapting to changes that arise as the regulatory environment continues to evolve and modernise.
- Revised Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued August 2022, all but one of the new provisions must be fulfilled by August this year.
- Digital transformation and quality system improvements should always be with a view to delivering something more than compliance, such as improved operational effectiveness and efficiency.
A robust manufacturing and supply chain quality backbone has never been more critical than now in Life Sciences. Standards are being raised right around the world now – not just in developed markets, but everywhere 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. Now, 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 guide.