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10.5 - Laboratory Physical and Chemical Testing 211.65 specifications and testing

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Description

specifications and testing

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

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

You must provide water that is safe and sanitary

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

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