10.8 - Laboratory Method Validation labellling including examinations and assays to

including examinations and assays to demonstrate batches of drug product meet established specifications of identity

when such water contacts components

You must quarantine materials and dietary supplements you receive before you use them in the manufacture of a dietary supplement until you collect representative samples of each unique lot and Quality control personnel review and approve the results of any tests or examinations conducted

or hold components of dietary supplements using approved chemical agents at the required frequency to prevent contamination

and storage operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labelled as specified in the manufacturing record

10.8 - Laboratory Method Validation labellling including examinations and assays toYou must verify that the laboratory examination and test methods are appropriate for their intended use for each supplement or drug. You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required. Non pharmacopeial, in house methods must be validated, see ICH Q2(R2)