WK92658 - New Guide for Evaluating the Risk of Cleaning Processes Using Process Capability for Pharmaceutical Products and Medical Devices

Work Item

ASTM WK92658

New Guide for Evaluating the Risk of Cleaning Processes Using Process Capability for Pharmaceutical Products and Medical Devices

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: 001

Ballot: E55.13 (25-01)

Status: In Balloting

New Guide for Evaluating the Risk of Cleaning Processes Using Process Capability for Pharmaceutical Products and Medical Devices

1. Scope

Keywords

Rationale

Details

Work Item Status

Related

New Guide for Evaluating the Risk of Cleaning Processes Using Process Capability for Pharmaceutical Products and Medical Devices

1. Scope

Keywords

Rationale

Details

Work Item Status

Related