GB/T 17000-1997
Replaced
T/SHPPA 005-2019
Active
Group standards
T/SHPPA 005-2019 General technical requirements for the production of human recombinant monoclonal antibody products
T/SHPPA 005-2019 General technical requirements for the production of human recombinant monoclonal antibody products
Price:
$ 20.00
Basic Information
Standard Code:
T/SHPPA 005-2019
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medicine, health, and labor protection
ICS Name:
Other standards related to quality
Publish Date:
2019-11-01
Implement Date:
2020-01-01
Scope
Scope: These general technical requirements apply to the entire process of commercial production of monoclonal antibody products. Clinical trial drugs prepared in accordance with GMP requirements may be implemented as a reference; Main technical content: These technical requirements set forth requirements for all aspects of the production of human recombinant monoclonal antibody products from six aspects: principles, personnel, plant and equipment, material management, production and quality control, and quality management.
Development Information
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