8.5 - Laboratory Controls - Physical and Chemical Testing limit of quantification and contamination

and contamination

of materials or drug product must be examined visually for appropriate labeling as to contents

SOP and report form for determining the consistency

pending the appropriate sampling

or holding of a drug product shall wear clean clothing appropriate for the duties they perform

8.5 - Laboratory Controls - Physical and Chemical Testing limit of quantification and contaminationAppropriate physical and chemical tests or examinations must be performed by qualified personnel on representative samples of components, packaging, labels, in process materials, and drug products according to their established specifications to help determine if the specification for identity, strength, quality and purity is met