Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data

References

1. 1.↵
   European Medicines Agency, EU GMP Guide Annex 1: Manufacture of Sterile Medicinal Products. EMA: London, 2009.
2. 2.↵
   U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Centers for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004.
3. 3.↵
   1. Gordon O.,
   2. Goverde M.,
   3. Pazdan J.,
   4. Staerk A.,
   5. Roesti D.

   Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data. PDA J. Pharm. Sci. Technol. 2015, 69 (3), 383–398.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   1. Levinson W. A.

   Statistical Process Control for Real-World Applications; CRC Press-Taylor and Francis, Boca Raton, FL, 2010.
5. 5.↵
   Parenteral Drug Association Inc. Technical Report 13 (Revised): Fundamentals of an Environmental Monitoring Program; PDA: Bethesda, MD, 2014.
6. 6.↵
   1. Wilson J. D.

   Setting Alert/Action Limits for Environmental Monitoring Programs. PDA J. Pharm. Sci. Technol. 1997, 51 (4), 161–162.

   OpenUrlFREE Full Text
7. 7.↵
   World Health Organization. Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities, 2012,. WHO Web site. www.who.int/immunization_standards/vaccine_quality/env_monitoring_cleanrooms_final.pdf. (accessed August 10, 2021).
8. 8.↵
   1. Bethea R. M.,
   2. Duran B. S.,
   3. Boullion T. L.

   Statistical Methods for Engineers and Scientists, Marcel Decker, Inc, 1985.
9. 9.↵
   U.S. Pharmacopeial Convention, General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments. In USP 43—NF 38, USP: Rockville, MD, 2020.
10. 10.↵
    1. Caputo R. A.,
    2. Huffman A.

    Environmental Monitoring: Data Trending Using a Frequency Model. PDA J. Pharm. Sci. Technol. 2004, 58 (5), 254–260.

    OpenUrlAbstract/FREE Full Text
11. 11.↵
    1. Yang H.,
    2. Zhao W.,
    3. O'day T.,
    4. Fleming W.

    Environmental Monitoring: Setting Alert and Action Limits Based on Zero-Inflated Model. PDA J. Pharm. Sci. Technol. 2013, 67 (1), 2–8.

    OpenUrlAbstract/FREE Full Text
12. 12.↵
    American National Standards Institute; American Society for Quality. ANSI/ASQ Z1.4–2003: Sampling Procedures and Tables for Inspection by Attributes; ASQ: Milwaukee, WI, 2003.
13. 13.↵
    1. Montgomery D. C.

    Introduction to Statistical Quality Control, 3rd ed.; John Wiley & Sons, Inc: New York, 1997.
14. 14.↵
    1. Purkar S. T.,
    2. Khandwawala A. I.

    Construction of Operating Characteristics Curve for Acceptance Sampling Plan by Using MATLAB Software. Int J. Eng. Sci. 2012, 1 (1), 44–48.

    OpenUrl