10.5 - Laboratory Physical and Chemical Testing 211.65 specifications and testing

specifications and testing

the appropriateness of current specifications for both starting materials and finished product

Quantitative test methods must be validated by determining in assays the sensitivity

You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine that specifications are met

10.5 - Laboratory Physical and Chemical Testing 211.65 specifications and testingWet chemistry requirements of the Quality Control (QC) Laboratory with respect to written procedures and specifications, equipment, calibration, sampling, reagents, standards, and glassware, in order to perform USP, EP or other recognised test methods, or validated in house methods