Bộ tiêu chuẩn ASTM cho ngành Dược

 

ASTM E2500-20: Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ASTM E2810-19: Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

ASTM E3077-17: Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

ASTM E3106-18: Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

ASTM E3219-20: Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)

ASTM E3263-20: Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

ASTM F838-20: Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

ASTM E2629-20: Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

ASTM E2891-20: Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

ASTM E2898-20: Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

ASTM E3177-18: Standard Guide on Sampling for Process Analytical Technology