T/SHPPA 028-2024 Active
T/SHPPA 028-2024 The quality requirements for clinical treatment bacteriophages
Abstract
Scope: This document is applicable to the quality evaluation of lytic phage preparations for human treatment. The quality evaluation of phage preparations for animal treatment can be referred to this document. Main technical content: This document specifies the detection conditions, detection items, limit standards, and detection methods for phage preparations used in clinical treatment. According to the different dosage forms of phage preparations, the detection items include identification, pH, moisture content, potency, microbial limits, bacterial endotoxins, and sterility. At the same time, corresponding provisions are made for batch division and batch number preparation, as well as sampling.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/SHPPA 028-2024 |
| CCS | Medicine, health, and labor protection |
| ICS | Other standards related to quality |
| Implement Date | 2024-10-08 |