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6 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Quality Compliance O ver the past five years, global regulators have started a dialogue with pharmaceutical manufacturers about how best to measure quality (1). Frank discussions are taking place about management and corporate cultures (2) and whether they advance or impede efforts to establish opera- tional excellence and customer-focused quality. Efforts to study the relationship between quality and manufactur- ing performance peaked in the 1950s and 1960s. Inspired by thinkers such as Peter Drucker (3), W. Edwards Deming, and Taiichi Ohno, former chairman of the Toyota Motor Corp. in Japan, corporate leaders in a number of industries began to view quality as a revenue- creating opportunity rather than a cost center, and looked for new ways to empower workers to achieve excellence. The work clearly paid off. In 2014, in a study of 60 corporations, the Harvard Business School found that companies with strong quality cultures saved an average of $350 million per year (4). The first formal operational excellence programs embracing these concepts took off in the pharmaceutical industry in the late 1980s. In 2014, the Parenteral Drug Association (PDA) surveyed pharmaceu- tical companies on quality practices and set up a task force to help elucidate current connections between culture, behavior, and quality attributes, and to show how quality culture is ref lected in manu- facturing and quality performance. PDA then teamed up with the University of St. Gallen, Switzerland, to analyze survey results along with data from the Swiss university's extensive studies of pharma- ceutical manufacturing and quality practices. The research focused on such metrics as communication; transparency; commitment and employee engagement; and standardization of requirements. Ma- ture quality practices were defined as being objective and verifiable DUSANPETKOVIC1 - STOCK.ADOBE.COM Moving From Compliance to Quality Agnes Shanley Too narrow a focus on regulatory compliance may prevent organizations from embracing—and profiting from—quality and operational excellence.