Bringing rigour to global supply chains as the reinvention of medicine continues
by: Dr. Eduard Cayon, VP Audit Services, Rephine
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, we’ve seen a number of important trends emerge or deepen, which are having a significant impact on our sector.
As a result of the pandemic, then aggravated by the war situation in Europe, the problem of shortages of some medicines remains. The closure of China and the difficulties in the supply of raw materials present a major problem.
At a more strategic level, we’re seeing a whole raft of innovation 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.
Fostering safe innovation through GxP rigour
To keep pace with all of this activity, and to maintain and increase patient safety, regulations continue to be updated and strengthened. We’re seeing new harmonised standards and guidelines being published whose changes are based on the need for better scientific and technical knowledge of the processes, as well as risk-based management.
Developed 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 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 as their framework and guide.
Keeping on top 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. Having access to specialist consultancy and auditing services is becoming essential.
Lessons from the Covid-19 chapter
Looking specifically at audit services, the pandemic provided Rephine with the opportunity to develop new remote methodologies and test their advantages and limitations.
We do see continued value for remote activity, which can help ensure best use of auditors’ time during an inspection. In this context, remote sessions can add value in the preparation of audits in telematic meetings; the review of CAPAs; the clarification or extension of information, or even for performing some audits where 360º vision is not fundamental. This potential is assessed via a risk analysis before and after the audit.
For any critical auditing activity, however, on-site inspections remain essential.
Quality developments
At Rephine, we have always been committed to being “market driven”, which ensures we are very attuned to changes in this industry and in the needs of our clients. We pride ourselves on harnessing digital transformation and quality system improvements to clearly focus on being an aid to effectiveness and efficiency.
We’re also consistently up to date with new chemical-pharmaceutical processes and technologies, enabling us to be a good and trusted support – 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.
From new cleanroom measures to sustainable supply chains: what’s coming next
2023 is set to be another milestone year in Life Sciences, and we’re ready for a new surge of activity. Sterile drugs are currently regaining prominence on the pharmaceutical manufacturing map. With this in mind, the implementation of the changes related to the new Annex 1 to EU GMP is a challenge we look forward to helping our customers with. We can perform gap assessments and build a good action plan, or support manufacturers as they develop specific activities as part of that roadmap.
Meanwhile the need to identify and secure new sources of raw materials will see clients looking for assurances about those suppliers’ quality controls. With the most extensive and trusted audit services in the market, we are anticipating a surge of demand for our expert help here.
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 digital technologies and the intricacies of the processes to be digitalized. We are specialists in both, so are perfectly positioned to support for our customers as they look to redesign processes, chose the best digital platforms, and implement and validate them.
Whatever 2023 has in store, Rephine is ready
We are immensely proud of our positioning and expansion in the market, now as a deeply experienced Life Sciences supply chain business process consultancy, offering both customised advice and a full suite of tailor-made audit and quality assurance services.
The sum of our current capabilities, following the merger of Rephine, TDV and AFA in 2022, takes us a long way towards our goal of becoming the clear choice and most reliable reference within our industry. Our activities around the world are reinforced by having the best professionals in each region, allowing us to provide an agile service of the highest calibre.