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Standard Guide for Using FMECA and HACCP for Performing Risk Identification, Risk Analysis & Risk Control on Cleaning Processes for Pharmaceuticals and Medical Devices
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.
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