10.8 - Laboratory Method Validation labellling You must quarantine materials and

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

when such water contacts components

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

or contact surfaces from becoming contaminated

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

10.8 - Laboratory Method Validation labellling You must quarantine materials andYou 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)