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
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 10-29-2024
Technical Contact: Andrew Walsh
Item: 001
Ballot: E55.13 (25-01)
Status: In Balloting