10.5 - Laboratory Physical and Chemical Testing 211.65 or holding of a drug

or holding of a drug product shall be maintained in a clean and sanitary condition

You must provide water that is safe and sanitary

specifications and testing

The measures to prevent cross-contamination should be commensurate with the risks using Quality Risk Management principles to assess and control the risks

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

10.5 - Laboratory Physical and Chemical Testing 211.65 or holding of a drugWet 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