10.0 - Laboratory Operations rework identified through a sound statistical

identified through a sound statistical sampling plan (or otherwise every finished batch)

without being a source of contamination

There shall be written procedures for production and process control designed to assure that the drug products have the correct identity

The level of effort

supplying or exporting medicinal products or active ingredients

10.0 - Laboratory Operations rework identified through a sound statisticalYou must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine whether components, in process checks, and dietary supplements meet specifications. You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met