The Food and Drug Administration (FDA) has issued a proposed rule amending the sterility test requirements for biological products, including vaccines and stem-cell treatments.
Aimed at providing manufacturers with “greater flexibility to encourage use of the most appropriate and state-of-the-art test methods,” the proposal is part of FDA’s efforts to review and update biologics regulations as necessary. FDA requests comments by September 19, 2011.
According to FDA, manufacturers of cell and gene therapy products “may benefit from sterility test methods with rapid and advanced detection capabilities.” To ensure that biological products are sterile, the proposed rule addresses testing of novel and currently approved products and urges manufacturers to adopt latest test methods tailored to specific products with appropriate sample sizes. Recognizing that final containers supply the most-appropriate material to test, the proposed rule would eliminate sterility testing for most bulk material. It also calls for repeat sterility tests to occur only once for each lot.
FDA plans to maintain current exceptions to sterility test requirements for whole blood, Cryoprecipitated AHF, platelets, red blood cells, plasma, source plasma, smallpox vaccine, reagent red blood cells, anti-human globulin, and blood grouping reagent. “However, we request comment on whether any of these current exceptions should be removed,” FDA said. “For example, we specifically request comment on whether to remove the exemption for platelets. Bacterial contamination of platelets is a recognized public health risk and the blood collection industry has already called for and implemented methods to detect and limit or inactivate bacteria in platelet components. Requiring testing for platelets would be consistent with these industry practices.” See Federal Register, June 21, 2011.