Our organization is transitioning from a third-party compounder to compounding in-house. We are primarily a medical device manufacturer but have started to dive into OTC. In working through 21 CFR 210/211, there are specific requirements for retains. From a compounding aspect, are there specific requirements for retaining bulk samples for medical device (e.g., gel) vs the final finished good? We already have a retention program in place for FG. Some of our gels also have limited expiration dates and must be packaged within 5 days of compounding which also throws a wrench in a retention time of bulk.
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Stacey Benser
Senior Quality/Regulatory Manager
HR Pharmaceuticals, Inc
York PA
United States
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