T/CAPEB 00001.8-2022 Active Group standards

T/CAPEB 00001.8-2022 Pharmaceutical equipment—Vessel and pipe—Part 8:Validation

Publish Date: 2022-11-08 Implement Date: 2023-05-07 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/CAPEB 00001.8-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Pharmaceuticals, safety machinery, and equipment

ICS Name: -

Publish Date: 2022-11-08

Implement Date: 2023-05-07

Pages: 16 pages

Scope

This document specifies the requirements for document and record control, risk assessment, design validation, installation validation, operational validation, performance validation, and change and deviation management for containers and pipelines in pharmaceutical equipment that need to be cleaned, disinfected, sterilized, and validated in accordance with process requirements. This document applies to container and pipeline systems used in new construction, renovation, and expansion projects of pharmaceutical enterprises, and to the validation activities required before the equipment is officially put into use and used to produce drugs. This document does not apply to the validation of control systems related to containers and pipelines.