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

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 some element of inspections. Certainly, there is continued potential for remote auditing activity, which can help ensure best use of auditors’ time during an inspection – as long as all stakeholders appreciate and respect the limitations of the medium.

Remote sessions between inspectors and auditees can add value in the preparation of audits in telematic meetings; the review of CAPAs (corrective and preventive actions); the clarification or extension of information; and even for performing some audits where 360º vision is not fundamental. The realistic scope for remote activity should be assessed via a risk analysis before and after an audit. For any critical auditing activity, however, on-site inspections remain essential.

To come: updated cleanroom measures & next-gen tech validation

2023 will be another milestone year in Life Sciences, 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.

Across the board, 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 digitalized. This isn’t just about getting the most out of new systems, but 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.

That means planning well for all potential target outcomes, rather than trying to add new capabilities at the eleventh hour and potentially undermining system validation, while sending implementation costs soaring. 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.

Ensuring payback from Quality investments

Of course, 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. 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.

Whatever 2023 has in store, Life Science manufacturers will need to be ready with an actionable plan.