T/SHPPA 012-2022 Active

Scope: This document specifies the technical requirements for validating the rapid sterility testing method for cell and gene therapy products using a culture system based on the principle of microbial growth. This document applies to cell and gene therapy products with a short shelf life and small batches, for which it is impossible to ensure that the release inspection is completed before product use using current pharmacopoeia methods. It can also serve as a reference for implementing the rapid sterility testing method during the clinical trial phase of cell and gene therapy products. Main technical content: Cell and gene therapy products differ from traditional sterile drugs in that they have significant process differences, low production volumes, short shelf lives, and urgent clinical needs. Existing pharmacopoeia sterility testing methods are difficult to apply, so rapid testing of the products is needed. This standard mainly stipulates the validation requirements for the rapid sterility testing method, which should at least include: specificity, detection limit, reproducibility, and durability. At the same time, it also sets requirements for the parallel implementation period with pharmacopoeia methods and the re-confirmation or re-validation of the method.