Work Item
ASTM WK81051

Revision of E2476-16 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture


Updated in response to comments received during the reapproval of this standard


Developed by Subcommittee: E55.01

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 02-18-2022

Technical Contact: Benoit Igne

Item: 002

Ballot: E55 (22-05)

Status: Negative Votes Need Resolution

Item: 002

Ballot: E55 (22-02)

Status: Will Reballot Item