As per CFR 211.170, the FDA requires reserve samples of each lot of pharmaceutical products to be stored during the shelf life of the product. Drug products must be stored in the original container-closure in which it is packaged and/or marketed and stored for at least one year past the product’s expiry date.
Whether you are looking for reserve sample storage for commercial or clinical drug products, Siris provides reserve sample storage services for your pharmaceutical drug products. Reserve samples are inspected upon receipt and stored appropriately at your drug products appropriate storage conditions in one of our temperature-controlled, monitored and secure facilities. Samples are stored for at least one year past the expiry date, but are ultimately kept as long as you need and will only be destroyed with client request and approval.
Another requirement of CFR 211.170 is for reserve samples to receive Annual Visual Inspections (AVI) during the shelf life of your drug products. Siris provides Annual Visual Inspections on all samples and can customize inspection reporting to include any specific requirements you may have. We can also quickly provide inspections or shipments to your preferred laboratory if you experience any recalls, discrepancies or issues out in the market or at your clinical trial site.