GB/T 15692.2-1995
Replaced
T/SHQAP 001.2-2024
Active
Group standards
T/SHQAP 001.2-2024 Guidelines for Continuous Manufacture of Biopharmaceuticals Part 2: Formulations (Therapeutic Proteins)
T/SHQAP 001.2-2024 Guidelines for Continuous Manufacture of Biopharmaceuticals Part 2: Formulations (Therapeutic Proteins)
Price:
$ 20.00
Basic Information
Standard Code:
T/SHQAP 001.2-2024
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:
2024-04-08
Implement Date:
2024-05-07
Scope
Main technical content: This document proposes the general principles of continuous manufacturing of protein preparations prepared by engineered cells using continuous manufacturing technology, and suggestions for production management. This document is applicable to the production of protein preparations prepared by engineered cells using continuous manufacturing technology, including the integration of continuous raw materials and preparations, as well as the continuous production process of preparations.
Development Information
Same series standard
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