GB/T 13339-1991
Abolished
T/SHPPA 002-2020
Active
Group standards
T/SHPPA 002-2020 Narrow therapeutic index drug quality evaluation and standard development generic technical requirements
T/SHPPA 002-2020 Narrow therapeutic index drug quality evaluation and standard development generic technical requirements
Price:
$ 20.00
Basic Information
Standard Code:
T/SHPPA 002-2020
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medicine, health, and labor protection
ICS Name:
Quality management and quality assurance
Publish Date:
2020-05-20
Implement Date:
2020-07-01
Scope
Scope: This document is applicable to the quality evaluation and standard formulation of narrow therapeutic index drugs; Main technical content: The formulation of this document refers to the relevant laws, regulations, and technical requirements related to narrow therapeutic index drugs, and is based on the research data and clinical monitoring data of existing narrow therapeutic index drugs in R&D, production, circulation, and use. Based on the characteristics of NTIDs and the risks of clinical use, this technical requirement takes quality management as the core and makes provisions in terms of quality evaluation and the establishment of quality standards.
Development Information
Related Standards
GB/T 13340-1991
Abolished
GB/T 13340-1991 Methods for determination and calculation of quality grading rate of products
GB/T 13341-1991
Abolished
GB/T 13341-1991 Methods for determination and accounting of quality failure rate
GB/T 19004.3-1994
Abolished
GB/T 19004.3-1994 Quality management and quality system elements—Part 3:Guidelines for processed materials
GB/T 19004.2-1994
Abolished
GB/T 19004.2-1994 Quality management and quality system element—Part 2:Guidelines for services
GB/T 19000.4-1995
Abolished