GB/T 13339-1991
Abolished
T/SHPPA 024-2023
Active
Group standards
T/SHPPA 024-2023 Quality Management Specification for Drug Safety Activities Delegation
T/SHPPA 024-2023 Quality Management Specification for Drug Safety Activities Delegation
Price:
$ 20.00
Basic Information
Standard Code:
T/SHPPA 024-2023
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:
2023-12-25
Implement Date:
2024-01-06
Pages:
14 pages
Scope
Scope: This document specifies the procedures and requirements for the outsourcing of pharmacovigilance, and defines the content of the outsourcing, quality objectives of the outsourcing, etc. This document applies to sponsors of clinical trials and marketing authorization holders who outsource pharmacovigilance products and services to suppliers to carry out pharmacovigilance activities, and also applies to the outsourcing of pharmacovigilance activities within group companies (including commercial companies within the group); Main technical content: This document sets forth requirements for the management of outsourcing pharmacovigilance activities, and makes provisions on the form of outsourcing, scope of outsourcing, responsibilities of outsourcing, and content of outsourcing. At the same time, it also clarifies requirements for the quality objectives of outsourcing pharmacovigilance activities and data security 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