WK92658 - New Guide for Evaluating the Risk of Cleaning Processes Using Process Capability

Work Item

ASTM WK92658

New Guide for Evaluating the Risk of Cleaning Processes Using Process Capability

1. Scope

Cleaning processes for Active Pharmaceutical Ingredients (APIs) finished dosage forms, over-the-counter, veterinary, biologics, clinical supplies, medical devices, cosmetics, and consumer products.

Keywords

Process Capability, Process Capability Index, Cpu

Rationale

There are no standards or guidance on how to use process capability for evaluating cleaning processes

Details

Developed by Subcommittee: E55.13

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 10-29-2024

Technical Contact: Andrew Walsh

Item: 000

Ballot:

Status: