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4.0 - Equipment Design and Construction reprocessFor 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
Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records
one investigation per OOS test parameter
environment
to enable that person to perform the assigned functions
without being a source of contamination
packaging material
quality or efficacy
identified through a sound statistical sampling plan (or otherwise every finished batch)
comply with applicable Federal
performed maximum annually once the drug is marketed
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
calibration
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