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Why are you writing a Business Continuity Plan (BCP)?
In our case, a client auditor reviewing our quality systems for cGMP compliance noted that while we had SOPs in place on Disaster Recovery, Backup Power Generation, Preservation of Raw Data, Safety and others to deal with adverse events that can disrupt the business of the laboratory, we did not have a formal BCP. It was to meet our client’s expectations, not to comply with the cGMPs, GLPs or ISO standards, that we wrote the BCP.
In the process, we learned that the BCP, to be more than a document, has to be part of a Businesvs Continuity Management (BCM) system. The BCM system supports the plan and fosters its continual improvement.
During manufacturing, medical devices are exposed to a wide range of processing agents and materials. Depending upon the medical device, residual levels of these processing agents and materials pose a potential toxicological risk to patients. Therefore manufacturers of medical devices need to identify and properly control for contamination of the medical device from processing agents and materials encountered during the manufacturing of the device. This is done by validation of the cleaning of the medical device.
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The demand for sophisticated drug delivery has led to the development of many innovative combinations of pharmaceuticals, biologics and medical devices across a broad range of therapeutic areas. While these combination products have the potential to fulfill major unmet medical needs, they also present unique challenges in development and approval. One of these challenges is the development and validation of analytical methods to assess the quality, safety and stability of combination products. This white paper will focus on the analytical methods needed for single entity combination products.
Recent changes in the FDA’s 510(k) requirements for medical device applications have spawned many inquiries from clients on how to address the request for extractables, leachables and drug compatibility data. Meeting the expectations of the CDRH can be challenging in that any given study design is not universally applicable to all devices. A good study design requires elements of the best practices documented in ISO-10993-12, the PQRI guidance for E&L testing of OINDP as well as any specific requests for drug compatibility data from CDRH.
A hybridized study design, incorporating the essential regulatory elements, has been developed and successfully implemented for a variety of medical device applications. The rationale behind selection of the elements, overall experimental design strategy and interpretation of the resulting data will be presented.