10.8 - Laboratory Method Validation labellling or contact surfaces from becoming

or contact surfaces from becoming contaminated

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

in an unopened state

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

properly storing and disposing of equipment and trash

10.8 - Laboratory Method Validation labellling or contact surfaces from becomingYou 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)