Research ArticleTechnology/Application
Statistical Quality and Process Control in Biopharmaceutical Manufacturing—Practical Issues and Remedies
Nicolas Heigl, Bernhard Schmelzer, Franz Innerbichler and Mahesh Shivhare
PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 425-444; DOI: https://doi.org/10.5731/pdajpst.2020.011676
Nicolas Heigl
Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria
Bernhard Schmelzer
Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria
Franz Innerbichler
Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria
Mahesh Shivhare
Novartis AG, Biochemiestraße 10, 6336 Langkampfen, Austria

References
- 1.↵
- Shewhart W. A.,
- Deming W. E.
- 2.↵
- Shewhart W. A.
- 3.↵
- Deming W. E.
- 4.↵
- Box G. E. P.,
- Luceno A.,
- Paniagua-Quinones M.
- 5.↵
- Montgomery D. C.
- 6.↵
- Wheeler D. J.,
- Chambers D. S.
- 7.↵
- Wheeler D. J.
- 8.↵
- Wheeler D. J.
- 9.↵
- Grant E. L.,
- Leavenworth R. S.
- 10.↵U.S. Food and Drug Administration. Guidance for Industry: (Q8 (R2)) Pharmaceutical Developments; U.S. Food and Drug Administration: Rockville, MD, 2009.
- 11.↵U.S. Food and Drug Administration. ORA Laboratory Manual—Section 4: Laboratory Applications of Statistical Concepts; U.S. Food and Drug Administration: Rockville, MD, 2013.
- 12.↵U.S. Food and Drug Administration. Guidance for Industry: (ICH Q-10) Quality Systems Approach to Pharmaceuticals Cgmp Regulations; U.S. Food and Drug Administration: Rockville, MD, 2006.
- 13.↵U.S. Food and Drug Administration. Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application; U.S. Food and Drug Administration: Rockville, MD, 2003.
- 14.↵U.S. Food and Drug Administration. Guidance for Industry: Process Validation: General Principles and Practices; U.S. Food and Drug Administration: Rockville, MD, 2011.
- 15.↵U.S. Food and Drug Administration. Guidance for Industry: Submission of Quality Metrics Data; U.S. Food and Drug Administration: Rockville, MD, 2016.
- 16.↵U.S. Food and Drug Administration. Topic 2—Stage 3 Process Validation: Applying Continued Process Verification Expectations to New and Existing Products. International Society for Pharmaceutical Engineering; online discussion paper, 2012.
- 17.↵Parenteral Drug Association. A-Mab: A Case Study in Bioprocess Development; Parenteral Drug Association: Bethesda, MD, 2009.
- 18.↵Parenteral Drug Association. Utilization of Statistical Methods for Production Monitoring; Parenteral Drug Association: Bethesda, MD, 2012, 59.
- 19.↵Parenteral Drug Association. Process Validation: A Lifecycle Approach; Parenteral Drug Association: Bethesda, MD, 2013, 60.
- 20.↵BioPhorum Operations Group. Continued Process Verification: An Industry Position Paper with Example Plan; BioPhorum Operations Group: Sheffield, UK, 2014, Vol. 1.
- 21.↵International Society for Pharmaceutical Engineering. Product Quality Lifecycle Implementation (PQLI)—SPC and Process Monitoring; International Society for Pharmaceutical Engineering, Online Discussion Paper, 2008.
- 22.↵ASTM International. Standard E2587-12: Standard Practice for Use of Control Charts in Statistical Process Control; ASTM International: West Conshohocken, PA, 2012.
- 23.↵ASTM International. Standard E29-13: Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications; ASTM International: West Conshohocken, PA, 2013.
- 24.↵
- Morrow T.,
- Felcone L. H.
- 25.↵
- Wheeler D. J.
- 26.↵
- Nelson L. S.
- 27.↵R Core Team. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing: Vienna, Austria, 2018.
- 28.↵
- Wickham H.
- 29.↵
- Bisgaard S.,
- Kulahci M.
- 30.↵
- 31.↵
- Persson T.,
- Rootzen H.
- 32.↵
- Haas C. N.,
- Scheff P. A.
- 33.↵
- Plutta P. L.
- 34.↵
- Boyer M.,
- Gampfer J.,
- Zamamiri A.,
- Payne R.
- 35.↵
- Parkesh V.,
- Rajoria R.,
- Kumar D.
- 36.↵
- Khlebnikova E.
- 37.↵
- Torbeck L. D.
- 38.↵
- Wheeler D. J.
- 39.↵
- Wheeler D. J.
- 40.↵
- Wheeler D. J.
- 41.↵
- Wheeler D. J.
- 42.↵
- Wheeler D. J.
- 43.↵
- Wheeler D. J.
- 44.↵
- Wheeler D. J.
- 45.↵
- Woodall W. H.
- 46.↵
- Hindle S. A.
- 47.↵
- Yang H.,
- Zhao W.,
- O'Day T.,
- Fleming W.
- 48.↵
- Yau K. K. W.,
- Lee A. H.,
- Wang K.
- 49.↵
- Ridout M.,
- Demetrio C. G. B.,
- Hinde J.
- 50.↵
- Armbruster D. A.,
- Pry T.
- 51.↵
- Rathore A. S.,
- Undey C.,
- Konold P.
- 52.↵
- Macgregor J. F.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 5
September/October 2021
Statistical Quality and Process Control in Biopharmaceutical Manufacturing—Practical Issues and Remedies
Nicolas Heigl, Bernhard Schmelzer, Franz Innerbichler, Mahesh Shivhare
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 425-444; DOI: 10.5731/pdajpst.2020.011676
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