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.
Airflow; Smoke study; Aseptic
This guides to provide best practices on how to comply with ISO, FDA and EudraLex requirements.
The title and scope are in draft form and are under development within this ASTM Committee.
Date Initiated: 10-16-2020
Technical Contact: Scott Drummond
Item: 001
Ballot: E55.06 (22-01)
Status: Negative Votes Need Resolution
Item: 000
Ballot:
Status: