Contract manufacturing
Medical device companies are recognising that QbD is not just about internal processes but also about strategic partnerships.
Turning data into quality
The heavy cross-functional investment in design quality and manufacturing is meant to result in higher product quality with fewer iterations, but the return on investment in QbD can often fall short of expectations, particularly if the money is spent on developing in-house processes. The inefficiency may come from the failure of continuous process verification programmes to make best use of manufacturing data. Real-time, transactional manufacturing data has great value in determining how any shortfall in quality has arisen. Understanding it can pay huge dividends down the line, not only when it comes to post-launch issues but also in the development stage before the product is finalised.
Outsourcing a host of QbD services – everything from initial risk management through post-market surveillance, including statistical DoE, risk-based control strategies and validation protocols – can leverage the investment that is being made by software vendors in developing QbD modules within their digital quality management systems (QMS). These systems are optimised to use data from manufacturing and a host of other processes to enable CMOs and OEMs to outsource QbD execution, data capture and regulatory-grade validation with confidence.
The services on offer come under ISO 13485 and FDA design-control frameworks, both of which are crucial for ensuring the quality and safety of medical devices throughout their life cycle. They establish a structured approach to design and development to ensure that devices meet user needs and regulatory
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requirements. Though they do differ in some respects, they share the same core principles of planning, specification, review and correction.
Software meets science
Software vendors are embedding QbD processes into QMS systems through modules that streamline processes, enhance traceability and facilitate proactive risk management, ultimately improving product quality and compliance. A QMS can be integrated into the entire design process so that key quality parameters are factored in at every stage. It can also identify, assess and mitigate any risks associated with product design and manufacturing, making risk management a proactive process.
Integration with manufacturing execution systems (MES) and ERP systems enables a QMS to provide real-time monitoring and control of production processes and some QMS solutions also offer statistical process control capabilities that allow manufacturers to track and analyse process variations and identify potential issues before major problems arise.
Through document management, change management and workflow automation through to high-end reporting and analytics on quality performance and compliance status, the latest generation of QMS solutions is enabling software vendors to help their clients build quality into their products and processes from the outset. While traditional approaches to QbD may bring significant value – for a price – a more dynamic, cost- effective and flexible approach is close at hand. ●
www.medicaldevice-developments.com
Andrii Yalanskyi/
Shutterstock.com
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