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ASTM WK5935

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Work Item: ASTM WK5935 - New Practice for Process Understanding Related to Pharmaceutical Manufacture and Control


Developed by Subcommittee: E55.01 | Committee E55 Home | Contact Staff Manager



1. Scope

This standard describes Process Understanding, as it applies to processes for pharmaceutical manufacture and control. Historically, process understanding has been function related within the pharmaceutical industry. This document is necessary to provide a wholistic approach to process understanding, and build on the concepts set forth in the FDAs PAT guidance.

Keywords

Process Design; Process Capability; Process Understanding

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

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Work Item Status:
Date Initiated:9-22-2004
Technical Contact: Jean M Geoffroy

Item: 001
Ballot: E55 (09-01)
Status: Negative Votes Need Resolution

Item: 001
Ballot: E55 (08-01)
Status: Withdrawn From Balloting

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