WK76297 - New Practice for GMP Implementation of Advanced Process Control (APC) in Commercial Manufacturing

Work Item

ASTM WK76297

New Practice for GMP Implementation of Advanced Process Control (APC) in Commercial Manufacturing

to develop guiding principles for the development of advanced process control for pharmaceutical processes

APC; pharmaceutical

currently no standards exist on this topic

Developed by Subcommittee: E55.13

Committee: E55

Staff Manager: Travis Murdock

Date Initiated: 03-18-2021

Technical Contact: Benoit Igne

Item: 001

Ballot: E55.01 (22-01)

Status: Will Reballot Item

Item: 001

Ballot: E55 (23-07)

Status: Will Reballot Item