REDUCING MICROBIOLOGICAL RISK AND USING QUALITY TOOLS IN THE PHARMACEUTICAL INDUSTRY

Manufacturing has been paid dividends for many years through the use of quality tools such as statistical process control, quality function deployment, vendor audit management, hazard analysis critical control points (HACCP), value stream analysis, and other valuation methods. In the highly regulated industries that manufacture pharmaceuticals, foods, and cosmetics, the quality control ‘scientists’ have been typically known to perform sampling and testing for determining the acceptability of finished products. During the past decade, the pharmaceutical industry has seen a significant regulator-industry aligned paradigm change and an important leap into the formality of quality improvement using quality tools. The paradigm of final product testing (and the myth of ‘testing quality into products’) has been challenged by both the industry and regulators. Recent industry and regulatory support of ‘risk-based’ concepts and principles are intended to produce a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety, and efficacy than in prior history.