Reserve Sample Storage

Integrated Analytical Laboratories, LLC (IAL) offers ICH compliant controlled chambers for Reserve Sample Storage and Customer Complaint Testing. FDA Title 21 Section 2110.170 indicates that reserve samples of active ingredients as well as drug products that are representative of entire lots shall be retained. Each reserve sample needs to have sufficient sample quantity to conduct each test needed to meet its specification at least twice. Each reserve sample needs to be maintained one year after the expiration date of the last lot of the drug product containing the active. As you are aware, this can amount to a great volume of reserve samples. 21 CFR Section 2110.170 also states that reserve samples need to be stored under conditions that are consistent with the product or ingredient labeling and statistical procedures need to be in place to determine the number of reserve samples that must undergo a visual inspection annually for evidence of deterioration.