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.
Cleaning, Cleaning Validation, Acceptance Limit, Maximum Safe Carryover, MSC, Total Organic Carbon, TOC, Visual Residue Limit, VRL Visual Inspection, Process Capability, Statistical Process Control, SPC
This standard will be used to provide guidance on implementing the E3106-18 Standard Guide Science-Based and Risk-Based Cleaning Process Development and Validation and for the E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs)
The title and scope are in draft form and are under development within this