T/CBPIA 0008-2024 Active Group standards

T/CBPIA 0008-2024 Recombinant oncolytic type II herpes simplex virus production technical specifications

Publish Date: 2024-10-26 Implement Date: 2024-11-26 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CBPIA 0008-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2024-10-26

Implement Date: 2024-11-26

Scope

Scope: This standard applies to the production management, quality control, and quality assurance activities of recombinant oncolytic herpes simplex virus type II. It is worth noting that, if there are changes related to the production and quality of recombinant oncolytic herpes simplex virus type II, they shall be implemented in accordance with current regulations and relevant technical guidelines for changes, and the approved registration production processes and quality control procedures shall not be altered based on this standard. Main technical content: This standard applies to the production management, quality control, and quality assurance activities of recombinant oncolytic herpes simplex virus type II. The main content includes: scope, normative reference documents, terms, definitions, and abbreviations, general requirements, organizational structures and personnel, production sites and facilities, production management, procurement control and material management, quality control, packaging, storage, and transportation. If there are changes related to the production and quality of recombinant oncolytic herpes simplex virus type II, they shall be implemented in accordance with current regulations and relevant technical guidelines for changes, and the approved registration production processes and quality control procedures shall not be altered based on this standard.