T/SHBX 003-2023 Active Group standards

T/SHBX 003-2023 Drug manufacturing process disposable polymer component extraction technology regulations

T/SHBX 003-2023 Drug manufacturing process disposable polymer component extraction technology regulations

Publish Date: 2023-03-23 Implement Date: 2023-04-23 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/SHBX 003-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Packaging materials and containers

ICS Name: Chemical analysis

Publish Date: 2023-03-23

Implement Date: 2023-04-23

Pages: 72 pages

Scope

1.1 This document provides the technical specifications for the extractable substance detection of disposable polymer components used in the single-use system (SUS) for contacting material solutions in the pharmaceutical process.

Development Information

Word Count: 132 Thousand words Pages: 72 pages

Referenced Standards

ICH Q3D(R2) ICH M7 USP<233>　元素杂质　程序

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