10.5 - Laboratory Physical and Chemical Testing 211.65 The measures to prevent cross-contamination

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

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

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

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

SOP and report form for the melting point determination of solid and semi-solid samples by Quality Control according to USP <741> and EP 2

10.5 - Laboratory Physical and Chemical Testing 211.65 The measures to prevent cross-contaminationWet 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