Sample retention time should be based on the shelf life/expiration date of the finished devices. You most likely will not find a definitive source, because this information needs to be established by the organisation themselves. As such, if you have a personal lubricant with an expiration date (or shelf life) of say 5 years, you would want to have a sample retention time at least 5 years from the date of manufacture. And it is always a good idea to extend the sample retention time beyond that for your established period of time, e.g. 6 months, 1 year, etc. Because inevitably you will have those customers call up that said they used the product, it did not work, and then realised it was 6 months past the expiration date.
You should establish a valid sampling method and sample size for the retention period. As example, if your personal lubricants are packaged in containers of 50 mL with batch sizes of typically 1000 units, you have to establish the sampling method from the finished batch and then a quantity say 10 units for sample retention. All of this should be defined, include rationale, and documented. The shelf life, sample retention time, sample retention quantity is left up to each organisation to define themselves as there is any number of different medical devices. it should be noted that there is no regulatory requirement in ISO 13485 or FDA QSR 21 CFR 820 for maintaining retained samples, but it is definitely good business practice, i.e. investigating customer complaints.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 21-Dec-2017 16:53
From: Anonymous Member
Subject: Sample Retention Time
This message was posted by a user wishing to remain anonymous
Does anybody know what the sample retention time is for personal lubricant and personal care products or can somebody direct me to a source where I may find that information?
Thank you.