Reserve Sample Storage

Reserve sample storage services in compliance with CFR 211.170

A clinical technician verifying information during a packaging job

Reference, Retain, and Reserve Samples

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.

Reserve Sample Storage Services

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.

Commercial or Clinical Reserve Sample Storage Services
Reserve Samples stored in compliance with Good Manufacturing Practices (cGMPs) and EU regulations
Annual Visual Inspections (AVI) as per CFR 211.170
Controlled Room Temperature Storage (20-25c)
Refrigerated Storage (2-8c)
Frozen Storage (-20c)

Reserve Sample Annual Visual Inspection

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.

Take the First Step With Siris

If you are looking for help with managing your clinical supply chain, please fill out the form below and a Siris representative will reach out to you as soon as possible. Or feel free to reach us at (908) 479-1331 or
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