Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

Importancia y uso:

4.1 Application of the approach described within this standard guide applies science-based concepts and principles introduced in the FDA’s initiative on pharmaceutical CGMPs for the 21st century.4

4.2 This guide supports, and is consistent with, elements from ICH Q8 – Q11 and guidelines from USFDA, European Commission, Pharmaceutical Inspection Co-operation Scheme, and the China Food and Drug Administration.8

4.3 According to FDA Guidance for Industry, PAT, “With real time quality assurance, the desired quality attributes are ensured through continuous assessment during manufacture. Data from production batches can serve to validate the process and reflect the total system design concept, essentially supporting validation with each manufacturing batch.” In other words, the accumulated product and process understanding used to identify the Critical Quality Attributes (CQAs), together with the control strategy, will enable control of the CQAs, providing the confidence needed to show validation with each batch. This is as opposed to a traditional discrete process validation approach.

Subcomité:

E55.11

Referida por:

E2629-20, E2656-16, E2656-16, E2500-20, E2968-23, E2500-20, E3326-22, E2629-20

Volúmen:

14.01

Número ICS:

03.120.10 (Quality management and quality assurance), 11.120.01 (Pharmaceutics in general)

Palabras clave:

continuous improvement; continuous process monitoring; continuous process verification; process capability analysis; process control strategy; process understanding; real-time release;