I personally would apply the same retention strategy for clinical and commercial products, but opinions may vary between your Quality colleagues and regulatory agencies (even between colleagues within the regulatory agency) In pursuing any strategy, put together your best possible justification (science/regulation/industry best practice-based) and sell it to your Quality Assurance and Regulatory brethren. You won’t want to be standing alone if some regulatory authority objects a few years down the road. (Make sure that your justification and multi-discipline approval are well documented and retrievable). As always, this forum welcomes all applicable input from our subscribers.
Reply To: CFR Reserve SamplesJohn O'Neill2022-11-18T10:04:58-05:00