Work Item
ASTM WK76297

New Guide for Advanced Process Control

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, specifications, and performance standards for the manufacture of pharmaceutical and biopharmaceutical products. The Committee will encourage research in this field and sponsor symposia, workshops, and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

Keywords

APC; pharmaceutical

Rationale

currently no standards exist on this topic

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

Details

Developed by Subcommittee: E55.01

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 03-18-2021

Technical Contact: Benoit Igne

Item: 000

Ballot:

Status: