10.8 - Laboratory Method Validation labellling with clearly defined areas to

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

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

when such water contacts components

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

EP or equivalent

10.8 - Laboratory Method Validation labellling with clearly defined areas 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)