T/SHPPA 012-2022
Validation technical requirements for rapid sterility testing method of cellular and gene therapy products (English Version)
- Standard No.
- T/SHPPA 012-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- Group Standards of the People's Republic of China
- Latest
- T/SHPPA 012-2022
- Scope
- Cell and gene therapy products are different from traditional sterile drugs. They have special characteristics such as large process differences, low output, short validity period, and urgent clinical needs. The existing pharmacopoeia sterility inspection method is difficult to apply, so the products need to be tested. Quick check. This standard mainly stipulates the verification requirements for rapid sterility testing methods, which should at least include: specificity, detection limit, reproducibility, and durability. At the same time, requirements are also put forward for the parallel implementation period with the pharmacopoeia method and the re-validation or re-validation of the method.
T/SHPPA 012-2022 history
- 2022 T/SHPPA 012-2022 Validation technical requirements for rapid sterility testing method of cellular and gene therapy products
