ISPE Field-Tests Quality Program

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2018 ISPE Quality Manufacturing Conferencethat it is field-testing the design principles of a comprehensive industry-ledprogram of self-evaluation of pharmaceutical quality program with industrycolleagues, senior leaders, and regulators. The vision for the program is toevolve the focus from submission of harmonized quality metrics as given inrecent FDA guidance documents to establishing a framework for advancing thestate of pharmaceutical quality, while at the same time continuing to alignwith the purpose outlined by FDA. ISPE believes this approach will deliver onthe objectives outlined by FDA and will increase the value to industry, ISPEsaid in a June 5, 2018 press release.

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