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Work Item

ASTM WK86188

New Guide for Risk Assessment of Cleaning Validation Programs

1. Scope
Pharmaceutical, biopharmaceutical, nutraceutical and cosmetics industry
Keywords
Risk Assessment; FMEA; HACCP; Risk Control; Risk Analysis; Risk Evaluation; Hazard Identification
Rationale

There is currently no guidance for industry to perform a Risk Assessment for cleaning validation programs as described by the ASTM E3106 Standard.

Details

Developed by Subcommittee: E55.13

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 05-02-2023

Technical Contact: Andrew Walsh

Item: 000

Ballot: 

Status: 

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