4.0 - Equipment Design and Construction reprocess performed maximum annually once the

performed maximum annually once the drug is marketed

environment

one investigation per OOS test parameter

the lot and any other implicated lots must be quarantined and an out of specification (OOS) investigation conducted to determine the validity of the result

4.0 - Equipment Design and Construction reprocess performed maximum annually once theFor the production of dietary supplements you must use equipment and utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained thus preventing cross contamination