Certain medical devices utilize materials of animal origin, and the regulatory requirements are outlined in the ISO 24422-2 standard introduced below. PharmOut regularly assists clients to audit their suppliers of materials of animal origin to ISO 22442 and ISO 13485 and can help you prepare. We can facilitate both onsite and remote auditing, as well as provide recommendations and guidance on addressing and resolving your audit deficiencies.
Animal tissues and their derivatives are used in the design and manufacture of medical devices to provide performance characteristics that have been chosen for advantages over non-animal based materials. The range and quantities of materials of animal origin in medical devices vary. These materials can comprise a major part of the device (e.g., bovine/porcine heart valves, bone substitutes for use in dental or orthopaedic applications, haemostatic devices), can be a product coating or impregnation (e.g., collagen, gelatine, heparin), or can be used in the device manufacturing process (e.g., tallow derivatives such as oleates and stearates, foetal calf serum, enzymes, culture media).
Tissues and derivatives for use in medical devices are typically obtained by the manufacturer from a range of sources such as animal herds or flocks and commercial harvesting (including fishing). Some specialized industries also process materials of animal origin to manufacture a finished product (e.g., gelatine) which is incorporated as a raw material into the finished medical device by the manufacturer. PharmOut has extensive experience in auditing to the ISO 22442-2 standard and can help you meet your regulatory/customer requirements – contact us to discuss.
If you have an ISO 24422-2 audit coming up, or just want a check on the current compliance status of your facility, make sure you are audit-ready by having a pre-audit performed by one of our experienced consultants.
PharmOut can help you set up a GMP vendor management audit programme to assess the GMP compliance of suppliers.
Receiving a notice of deficiencies after an audit by a regulator is never pleasant. For some companies it will mean major remediation efforts are required, for others it may mean having to address a few small issues. PharmOut can help prepare your GMP Audit Response.
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