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10.5 - Laboratory Physical and Chemical Testing 211.65 the appropriateness of current specifications

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Description

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

or label to make it suitable for use in the manufacture of a dietary supplement unless Quality control personnel conduct a material review and make a disposition decision to approve this

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

10.5 - Laboratory Physical and Chemical Testing 211.65 the appropriateness of current specificationsWet 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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