Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

Importancia y uso:

4.1 Application of the approach described within this guide applies risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for cleaning should also be commensurate with the level of risk.

4.2 Application of the approach described within this guide applies many of the science-based, risk-based, and statistical concepts and principles introduced in the FDA’s Guidance for Industry Process Validation: General Principles and Practices (3) and Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement.

4.3 This guide supports, and is consistent with, elements from ICH Q8, ICH Q9, ICH Q10, ICH Q11, and ICH Q12.

4.4 This guide supports and is consistent with the content and intent of ISO 14971.

4.5 Key Concepts—This guide applies the following key concepts: (1) quality risk management, (2) science-based approach, (3) statistics-based approach, (4) process understanding, (5) continued improvement, and (6) life-cycle management as described in the ICH Q series.

Subcomité:

E55.13

Referida por:

G0122-20, F3127-22, D8219-19, E3263-22E01, G0121-18, E3219-20, E3418-23E01

Volúmen:

14.01

Número ICS:

13.020.60 (Product life-cycles)

Palabras clave:

acceptance limits; CIP; cleaning development; cleaning validation; HBEL; PAT; QRM; risk-based; science-based; Shirokizawa;