Biopharma Process Systems
Biopharma supplies freeze drying & bioprocessing equipment and services to the pharmaceutical, biotech & process industries across the UK & Ireland. They were asked by a leading diagnostics company to help them get a Covid-19 test to market as quickly as possible. Although used to analysis, process development and production projects, this would be a unique challenge.
Given the initial rise in the pandemic, the world was clamouring for reliable PCR tests in large volumes. The scale was above anything Biopharma had done before and required them to migrate into an ISO 13485 environment as quickly as possible.
1
New product introduction
2
Minor NCs
QFactorial Service offering
Implementation
Starting with our trademark Gap & Synergy Assessment, we worked closely with Biopharma to create and implement an action plan, closing the gaps and absorbing the synergies from existing process controls. Key elements of the QMS were delivered to a tight schedule, including the quality manual, policy, procedures, checklists, registers, audit schedule and internal audit.
Quality and Production are old adversaries. When the schedule is urgent – as in getting PCR tests to market during a pandemic – there is always a risk of quality being undermined by the pressure to ship more product, and faster. In this scenario, the role of ISO 13485 in establishing quality control and assurance is critical. We are pleased to have played a small role in this vital endeavour.
Working at the pace set by the client and the certification body, ISO 13485 was achieved within 9 months of our engagement, setting up the client for rapid and reliable production of Covid-19 PCR test kits.
Q! Feedback
“Although we have excellent in-house experience and robust existing systems, we needed some instant consultation on moving up to ISO 13485 and couldn’t risk falling short, so we sought a safe pair of hands to help us get over the line. It was particularly pleasing to achieve the standard with half as many OFIs and NCs as are typical. Without QFactorial we would have had a much-extended process and the flow of PCR tests would have been much reduced. Achieving ISO 13485 certification has enhanced our productivity and increased market interest from clients to support their projects, so money well spent.”
