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Work Item

ASTM WK85802

New Guide for Performing Failure Modes and Effects Analysis on Cleaning Processes

1. Scope
Pharmaceutical/biopharmaceutical cleaning processes, Medical Device cleaning processes, cosmetic cleaning processes
Keywords
Cleaning; Risk Assessment; FMEA; FMECA
Rationale

ASTM E3106 requires a Risk Analysis of cleaning procedures and there is no specific guidance on application of FMEA to cleaning processes. This Guide will facilitate this step in the E3106 Quality Risk Management Process

Details

Developed by Subcommittee: E55.13

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 03-30-2023

Technical Contact: Andrew Walsh

Item: 001

Ballot: E55.13 (24-01)

Status: Will Reballot Item

Item: 006

Ballot: E55 (24-06)

Status: Negative Votes Need Resolution

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Copyright/Permissions