ASTM E3470-25

1.1 This guide provides guidance on performing risk identification, risk analysis, and risk control on cleaning processes using failure modes, effects and criticality analysis (FMECA), and hazard analysis and critical control points/hazard analysis and risk-based preventive controls (HACCP/HARPC).

1.2 This guide applies to human and animal pharmaceuticals (including active pharmaceutical ingredients (APIs); commercial and clinical finished/final dosage forms (small molecule and biologics); and cosmetics and medical devices following all manufacturing and cleaning.

1.3 This standard does not apply to clinically-used medical devices.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

4.1 This standard provides guidance on using failure modes, effects and criticality analysis (FMECA), and hazard analysis and critical control points (HACCP) to perform the risk identification and risk analysis on cleaning procedures as required in Guide E3106. While this standard describes the use of FMEA/FMECA and HACCP/HARPC for risk analysis of cleaning processes, other risk assessment tools may be used as well (see ICH Q9 (R1) and ISO 13053).

4.2 Application of the approach allows data-driven risk reduction/risk control for manual, semi-automated (clean-out-of-place), and automated (clean-in-place) cleaning procedures and can be adapted/amended to specific cases.

4.3 Application of the approach allows evaluation of process analytical technology (PAT) tools to assess the adequacy of cleaning procedures (Guide E2476).

4.4 Key Concepts—This guide applies the following key concepts: (1) quality risk management (QRM), (2) failure modes, effects and criticality analysis (FMECA), (3) hazard analysis and critical control points (HACCP), (4) science-based approach, and (5) risk-based approach.