T/CBPIA 0001-2022 Active Group standards

T/CBPIA 0001-2022 Crafted Heparin Production Quality Management Guidelines

Publish Date: 2022-08-15 Implement Date: 2022-09-15 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 0001-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2022-08-15

Implement Date: 2022-09-15

Pages: 39 pages

Scope

Main technical content: This guide specifies the general requirements for the production process, quality management and control, and traceability management of crude heparin. This guide is applicable to evaluating the production quality and process conformity of crude heparin sodium. Drug marketing authorization holders (hereinafter referred to as "MAH") of heparin preparations and other heparin-based products (i.e., biological active substances) may refer to this guide for quality control of the process chain from the acquisition of starting materials and the manufacture of intermediates to the production of drug substances.