T/SHPPA 028-2024 Active Group standards

T/SHPPA 028-2024 The quality requirements for clinical treatment bacteriophages

T/SHPPA 028-2024 The quality requirements for clinical treatment bacteriophages

Publish Date: 2024-08-08 Implement Date: 2024-10-08 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
Price: $ 20.00
Download

Basic Information

Standard Code: T/SHPPA 028-2024
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: Medicine, health, and labor protection
ICS Name: Other standards related to quality
Publish Date: 2024-08-08
Implement Date: 2024-10-08
Pages: 7 pages

Scope

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.

Development Information

Pages: 7 pages

Related Standards

Contact Us