10.8 - Laboratory Method Validation labellling There must be sufficient qualified

There must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer

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

or contact surfaces from becoming contaminated

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

10.8 - Laboratory Method Validation labellling There must be sufficient qualifiedYou 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)