GB/T 15692.2-1995
Replaced
DB32/T 4556-2023
Active
Jiangsu ProvinceLocal standards
DB32/T 4556-2023 Guidelines for investigating out-of-specification test results for pharmaceutical production
DB32/T 4556-2023 Guidelines for investigating out-of-specification test results for pharmaceutical production
Basic Information
Standard Code:
DB32/T 4556-2023
Standard Type:
Local standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Integrated services in the fields of medicine, health, and labor protection
ICS Name:
Other standards related to pharmaceutics
Publish Date:
2023-09-22
Implement Date:
2023-10-22
Pages:
16 pages
Scope
This document provides the investigation process and methods for data exceeding standards in drug production inspections.
This document is applicable to laboratory inspection items that exceed quality standards, including materials (active pharmaceutical ingredients, excipients, drug packaging materials), intermediates, finished products, and stability study samples.
This document is not applicable to analytical method validation, inspector training, data generated during the verification of newly purchased instruments and systems (such as computerized systems), data generated by process analytical technology (PAT), and microbiology-related inspection items.
Development Information
Related Standards
GB/T 15692.6-1995
Replaced
GB/T 15692.6-1995 Terms of pharmaceutical machinery—Water treatment equipment for pharmaceutical use
GB/T 15692.7-1995
Replaced
GB/T 15692.7-1995 Terms of pharmaceutical machinery—Pharmaceutical packaging machinery
GB/T 15692.8-1995
Replaced
GB/T 15692.8-1995 Terms of pharmaceutical machinery—Medicine detecting instrument
GB/T 16312-1996
Abolished
GB/T 16312-1996 Chinese medicinal spray dryer system
GB/T 15692-2008
Replaced