GB/T 15692.2-1995
Replaced
T/SHQAP 013-2025
Active
Group standards
T/SHQAP 013-2025 Technical requirements of digital traceability in the whole process of drug production — Manufacturing super control and data acquisition
T/SHQAP 013-2025 Technical requirements of digital traceability in the whole process of drug production — Manufacturing super control and data acquisition
Price:
$ 20.00
Basic Information
Standard Code:
T/SHQAP 013-2025
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Biological products and blood products
ICS Name:
Other standards related to pharmaceutics
Publish Date:
2025-08-08
Implement Date:
2025-09-08
Scope
This document sets forth technical requirements for digital traceability in the collection and monitoring of production data for pharmaceutical manufacturers. It makes relevant provisions in the areas of data collection, data storage, real-time process monitoring, alarm management, and data management and operation and maintenance, with the aim of guiding pharmaceutical manufacturers in Shanghai to establish production data collection and monitoring systems that meet the requirements of the "Good Manufacturing Practice for Pharmaceutical Products (Revised in 2010)"
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