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.
stability study
This standard would be useful to simplify the initial assessment of stability for an IND submission.
The title and scope are in draft form and are under development within this ASTM Committee.
Date Initiated: 08-31-2018
Technical Contact: Robert Steininger II
Item: 003
Ballot: E55.04 (19-01)
Status: Will Reballot Item
Item: 002
Ballot: E55.04 (19-03)
Status: Will Reballot Item
Item: 001
Ballot: E55 (21-01)
Status: Negative Votes Need Resolution