title: Process validation.
abstract: Process validation is a required element in the clinical good manufacturing practice equation that helps to ensure that systems are performing in the intended manner and that the product we manufacture has the required potency, purity and safety. The parameters defined during the validation process help to define the elements of process control and provide a mechanism for on-going quality assurance, quality control, training, competency review and continuous improvement.
authors.affiliation: Progenitor Cell Therapy, LLC, Hackensack, NJ, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Preti
mesh_terms: D018952:Antigens, CD34 / Q000032:analysis; D064987:Cell- and Tissue-Based Therapy / Q000379:methods / Q000592:standards*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods / Q000592:standards*; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018952:Antigens, CD34