A renewed focus on supply chain quality: GxP evolution in 2023

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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.

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.

What’s ahead in 2023

2023 will be another milestone year from a quality and compliance perspective. Sterile drugs are currently regaining prominence on the pharmaceutical manufacturing map, for instance.

In Europe, this has given rise to adaptations to EU GMP. Revised Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued last August, starting the clock for compliance. All but one of the new provisions must be fulfilled by August this year.

The updated requirements are significant and wide-ranging, spanning the quality system and the manufacturing process itself. To ensure they are ready, affected manufacturers must now perform gap assessments and build a good action plan, or move forward with designated activities as part of that roadmap.

Overall, the opportunities presented by digital transformation, and regulators’ growing expectations for digital advancement, mean that manufacturers will need to understand both the capabilities of the new technologies and the intricacies of the processes to be digitalised. This isn’t just about getting the most out of new systems; it’s also about taking care when redesigning and optimising processes, choosing the best digital platforms, and implementing and validating them - with quality embedded right from the initial design.

All of this means planning well for all potential target outcomes, rather than trying to add new capabilities (and validate them) at the eleventh hour.

The new Annex 11 to EU GMP covers the associated changes currently being discussed by Medicines for Europe’s Quality working group. In the US, the FDA has also issued new guidance, based on Computer Software Assurance for Production and Quality System Software, and the ISPE GAMP guidance has been updated to GMP 5 2º edition.

Digital transformation and quality system improvements should always be with a view to delivering something more than compliance, of course - such as improved operational effectiveness and efficiency. Tangible, optimised progress will rely on companies having access to the latest knowledge of new chemical-pharmaceutical processes and technologies, to guarantee quality at all stages of drug development, from pre-clinical studies and clinical trials to the development of new treatments or manufacture of medical devices.

Certainly, companies will need to be ready with an actionable plan if they want to stay on the right side of the updated requirements.