10.8 - Laboratory Method Validation labellling or hold components of dietary

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

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

when such water contacts components

EP or equivalent

with clearly defined areas to prevent mix-ups or contamination with microorganisms

10.8 - Laboratory Method Validation labellling or hold components of dietaryYou 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)