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.

The title and scope are in draft form and are under development within this ASTM Committee.

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: