title: Risk/science-based approach to validation: a win-win-win for patients, regulators, and industry.
abstract: Regulatory compliance is often perceived to be in conflict with business success and profitability. In many cases this perception cascades down through the ranks, resulting in meeting only the letter of the law of the regulations without satisfying their intent. This in turn generates further problems that can ultimately lead to non-compliance and/or product failure with a negative impact on the patient, both in health risks and high costs of medication. In the end the conflict between regulatory and business generates risk for every facet of the health care system: patients, regulatory, and industry. This paper proposes a risk/science-based strategy for "validation" using design of experiments that will be viewed as a victory for all--patients, regulators, and industry--a win-win-win. This strategy offers vital assurance that regulatory will see no degradation of previous expectations, while affording business leaders a high level of confidence that compliance can also reduce waste within the business and therefore positively affect the bottom line. Science-based validation supports new FDA views outlined in a new Draft Guidance for Industry, PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, published August 2003. Patients can ultimately expect benefits in improved quality and lower cost. In short, the three-fold goals of this strategy are to achieve compliance to regulations, combined with return on investment (ROI) to industry, and lower health risks and costs to the patient.
authors.affiliation: Center for Risk-based Strategies, Inc., Grayslake, IL 60030, USA.
authors.forename: Karen A
authors.initials: KA
authors.lastname: Welch
authors.forename: Conrad A
authors.initials: CA
authors.lastname: Fung
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Schmidt
mesh_terms: D004345:Drug Industry; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical; D014481:United States; D014486:United States Food and Drug Administration