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T/CBPIA 0001-2022 Active
T/CBPIA 0001-2022 Crafted Heparin Production Quality Management Guidelines
Abstract
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.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/CBPIA 0001-2022 |
| ICS | Drugs |
| Implement Date | 2022-09-15 |
Price
$ 20.00
Subtotal
$ 20.00
Tax
$ 0.00
Order Total (incl. tax)
$ 20.00