GB/T 13339-1991
Abolished
T/SHPPA 001-2020
Active
Group standards
T/SHPPA 001-2020 Chemical Pharmaceutical Research Quality Management Guidelines
T/SHPPA 001-2020 Chemical Pharmaceutical Research Quality Management Guidelines
Price:
$ 20.00
Basic Information
Standard Code:
T/SHPPA 001-2020
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Integrated services in the fields of medicine, health, and labor protection
ICS Name:
Quality management and quality assurance
Publish Date:
2020-02-27
Implement Date:
2020-03-18
Scope
Scope: This guideline is applicable to pharmaceutical research activities such as the synthesis, formulation, and analysis of chemical drugs (including APIs and formulations) conducted for the purpose of drug registration. Early exploratory research can refer to this guideline for reference; Main technical content: This guideline mainly provides management guidelines for the pharmaceutical research phase of chemical drugs, namely the non-GMP phase, from the aspects of quality management, organizational structure and personnel, research sites and equipment instruments, material management, document and file management, electronic data management, implementation of research work, and laboratory safety management.
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