10.0 - Laboratory Operations rework without being a source of

without being a source of contamination

including written procedures for the tests and examinations that you conduct to determine whether specifications are met

supplying or exporting medicinal products or active ingredients

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

or holding of a drug product shall wear clean clothing appropriate for the duties they perform

10.0 - Laboratory Operations rework without being a source ofYou 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