T/CPAPE 01-2022 Active Group standards

T/CPAPE 01-2022 General technical requirements for producing sterile products using the Blow Fill Sealing (BFS) technology

Publish Date: 2022-05-06 Implement Date: 2022-06-01 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/CPAPE 01-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Medical and Health Technology (Vocabulary)

Publish Date: 2022-05-06

Implement Date: 2022-06-01

Scope

Scope: This document specifies the terms and definitions, abbreviations, BFS equipment classification and applications, design requirements, validation and verification, operation, and quality risk assessment for the production of sterile products using the Blow-Fill-Seal (BFS) technology. This document is applicable to the production of sterile products using the Blow-Fill-Seal (BFS) technology; Main technical content: This document is based on the requirements of Article 17 and Article 18 of Appendix I of Sterile Drugs in the Pharmaceutical Production Quality Management Regulations (revised in 2010), and references the "American Pharmaceutical Dosage Forms Council (PDA) Technical Report No. 77 'Using Blow-Fill-Seal Technology to Manufacture Sterile Drugs', the 'Considerations for the Production of Sterile Drugs and Infusion Products Using Blow-Fill-Seal Technology' (2012 Edition) of the International Blow-Fill-Seal Operators Association, and the content of 'Advanced Sterile Technology' in Chapter 1116 of USP 43/44 and 'Cleanliness Levels of Sterile Production Process Environments'".