Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach

Importancia y uso:

5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, for example, qualified, and to satisfy requirements for design, 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.

5.3 This guide supports, and is consistent with, the framework described in ICH Q8, ICH Q9, ICH Q10, ICH Q11, ICH Q12, and ICH Q13.

5.4 This guide is designed to conform with FDA Guidance for Industry Process Validation, EU GMP (Annex 11 and 15), and other international regulations regarding equipment and facility suitability for use and qualification.

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

Subcomité:

E55.11

Referida por:

E2476-22, E3051-25, E3106-22, E2656-25, E3051-25, E2629-20, E2363-23, E2656-25, E2476-22, E2363-23, E2898-20A, E3077-17E02, E2629-20

Volúmen:

14.01

Número ICS:

11.120.99 (Other standards related to pharmaceutics)

Palabras clave:

critical aspects; critical design elements; design; equipment; manufacturing systems; specification; system owner; verification;