Hi,
I am currently working in an In vitro diagnostic company and I am doing a study about expiry date of raw materials after package opening. It is hard to find datas about that and I try to extrapolate informations from unopened raw material package. I deduced 3 options to consider:
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Contact the vendor for data;
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Perform your own accelerated ageing, and concurrently, set aside product (the RM and/or the finished product) for real-time studies; sufficient qty to pull and test samples at several intervals up to the max. period desired;
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Industry standards / practices (supported by 2.).
I am presently contacting vendors for information about my study but some of them do not actually have the answer and we can not perform big stability studies because of the large range of our production.
Hence, could you please tell me, as you may know, how/where can I find “Industry standards/practices” about that kind of expiry date or maybe the standards for some kinds of “product families” which may have the same assignated expiry date because of their similarities.
Thank you, Best regards
Raphael,
Quality process support