Points to Consider When Using KPIs/Metrics

References

1. 1.↵
   U.S. Food and Drug Administration. Submission of Quality Metrics Data, Draft Guidance for Industry. FDA Web site, Nov 2016. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-quality-metrics-data-guidance-industry.
2. 2.↵
   1. Deming W. E.

   On a Classification of the Problems of Statistical Inference. J. Am. Stat. Assoc. 1942, 37 (218), 173–185.

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3. 3.↵
   PDA’s 4th Quality Metrics Conference, PDA Letter July-August 2017.
4. 4.↵
   Case for Quality Pilot report. FDA Web site, Jan 2020. https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality.
5. 5.↵
   U.S. Food and Drug Administration. Drug Shortages: Root Causes and Potential Solutions. FDA Web site, 21 Feb 2020. https://www.fda.gov/media/131130/download.
6. 6.↵
   U.S. Food and Drug Administration. Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers. Fed. Regist. 2020, 85 (201), 65824–65825.

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7. 7.↵
   U.S. Food and Drug Administration. Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities. Fed. Regist. 2020, 85 (201), 65828–65830.

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8. 8.↵
   Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S), Draft PIC/S Good Practices for Data Management and Integrity in GMP/GDP Environments. PIC/S: Geneva, 2018.
9. 9.↵
   International Conference for Harmonisation. Quality Guideline Q10: Pharmaceutical Quality System, ICH: Geneva, 2008.
10. 10.↵
    International Organization for Standardization, ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes. ISO: Geneva, 2016.
11. 11.↵
    Performance Indicator. Wikipedia. https://en.wikipedia.org/wiki/Performance_indicator.
12. 12.↵
    1. Patel P.,
    2. Baker D.,
    3. Burdick R.,
    4. Chen C.,
    5. Hill J.,
    6. Holland M.,
    7. Sawant A.

    Quality Culture Survey Report. PDA J. Pharm. Sci. Technol. 2015, 69 (5), 631–642.

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