Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing

Importancia y uso:

5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that SUS are fit for their intended use and to satisfy requirements for sourcing, supply, design, specification, installation, operation, and performance.

5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach. It supports and is consistent with the framework described in FDA Guidance for Industry—Process Validation: General Principles and Practices, in ICH Q7, ICH Q8 (R2), ICH Q9 (R1), and ICH Q10.

5.3 This guide includes concepts developed in the PDA Technical Report No. 66.

5.4 This guide may be used independently or in conjunction with other ASTM Committee E55 proposed standards to be published by ASTM International.

5.5 Specific standard practices about extractables, leachables, particulate matter, and integrity testing/leak detection, biocompatibility, and raw materials as available should be used by suppliers and end users and applied to their own manufacturing process facilities.

Subcomité:

E55.07

Referida por:

E2500-20, E3244-23, E2500-20, E3077-17E02, E3326-22

Volúmen:

14.01

Número ICS:

11.120.99 (Other standards related to pharmaceutics)

Palabras clave:

biopharmaceutical manufacturing process; end users; quality risk management; single-use system; suppliers; SUS;