Work Item
ASTM WK76297

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

1. Scope

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


APC; pharmaceutical


currently no standards exist on this topic

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


Developed by Subcommittee: E55.13

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 03-18-2021

Technical Contact: Benoit Igne

Item: 001

Ballot: E55.01 (22-01)

Status: Negative Votes Need Resolution