title: Process validation.
authors.affiliation: CBER/FDA, Rockville, MD 20852, USA.
authors.forename: M G
authors.initials: MG
authors.lastname: Beatrice
mesh_terms: D001688:Biological Products / Q000302:isolation & purification* / Q000592:standards; D001709:Biotechnology; D011786:Quality Control; D015203:Reproducibility of Results; D012449:Safety
chemical_list: D001688:Biological Products