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Research ArticleTechnology/Application

A Practical Discussion of Risk Management for Manufacturing of Pharmaceutical Products

A. Hamid Mollah, Harold S. Baseman, Mike Long and Anurag S. Rathore
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 271-280; DOI: https://doi.org/10.5731/pdajpst.2014.00975
A. Hamid Mollah
1Genentech, South San Francisco, CA, USA;
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  • For correspondence: amollah@gene.com
Harold S. Baseman
2ValSource, Jupiter, FL, USA;
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Mike Long
3ConcordiaValSource, Wayland, MA, USA; and
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Anurag S. Rathore
4Department of Chemical Engineering, Indian Institute of Technology, Delhi, India
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References

  1. 1.↵
    1. Mollah A. H.,
    2. Long M.,
    3. Baseman H. S.
    Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, 1st ed.; John Wiley & Sons: Hoboken, NJ, 2013.
  2. 2.↵
    ICH Q10, Pharmaceutical Quality System, ICH Harmonised Tripartite Guideline, June 2008.
  3. 3.↵
    ICH Q8 (R2), Pharmaceutical. Development, ICH Harmonised Tripartite Guideline, August 2009, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf.
  4. 4.↵
    1. Harms J.,
    2. Wang X.,
    3. Kim T.,
    4. Yang X.,
    5. Rathore A. S.
    Defining design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol. Prog. 2008, 24 (3), 655–662.
    OpenUrlPubMed
  5. 5.↵
    1. Rathore A. S.,
    2. Mhatre R.
    1. van Hoek P.,
    2. Harms J.,
    3. Wang X.,
    4. Rathore A. S.
    Case study on definition of process design space for a microbial fermentation step. In Quality by Design for Biopharmaceuticals: Perspectives and Case Studies, Rathore A. S., Mhatre R., Eds.; Wiley & Sons, Inc.: Hoboken, NJ, 2009; pp 85–109.
  6. 6.↵
    1. Rathore A. S.,
    2. Sofer G.
    1. Seely R. J.,
    2. Haury J.
    Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes. In Process Validation in Manufacturing of Biopharmaceuticals, Rathore A. S., Sofer G., Eds.; Taylor & Francis: Boca Raton, FL, 2005; pp 31–68.
  7. 7.↵
    1. Mollah A. H.,
    2. Long M,
    3. Baseman H. S.
    1. Baseman H. S.,
    2. Mollah A. H.
    Background and Introduction. In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, Mollah A. H., Long M, Baseman H. S., Eds.; John Wiley & Sons: Hoboken, NJ, 2013; pp 1–15.
  8. 8.↵
    1. Rathore A. S.
    A roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol. 2009, 27 (9), 546–553.
    OpenUrlCrossRefPubMed
  9. 9.↵
    ICH Q9, Pharmaceutical Quality System, ICH Harmonised Tripartite Guideline, June 2008.
  10. 10.↵
    1. Mollah A. H.,
    2. Long M,
    3. Baseman H. S.
    1. Walker M.,
    2. Busmann T.
    Risk Management Tools. In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, Mollah A. H., Long M, Baseman H. S., Eds.; John Wiley & Sons: Hoboken, NJ, 2013; pp 17–47.
  11. 11.↵
    1. Mollah A. H.,
    2. Long M,
    3. Baseman H. S.
    1. Long M.
    Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration. In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, Mollah A. H., Long M, Baseman H. S., Eds.; John Wiley & Sons: Hoboken, NJ, 2013; pp 49–73.
  12. 12.↵
    1. Mollah A. H.,
    2. Long M,
    3. Baseman H. S.
    1. Long M.
    Statistical Topics and Analysis in Risk Assessment. In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, Mollah A. H., Long M, Baseman H. S., Eds.; John Wiley & Sons: Hoboken, NJ, 2013; pp 75–88.
  13. 13.↵
    1. Mollah A. H.,
    2. Long M,
    3. Baseman H. S.
    1. Raschiatore M.
    Pharmaceutical Product Manufacturing. In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, Mollah A. H., Long M, Baseman H. S., Eds.; John Wiley & Sons: Hoboken, NJ, 2013; pp 275–323.
  14. 14.↵
    1. Miele W.
    A Science and Risk Based Approach to Microbiological Control of Manufacturing Environments Applicable to Multiple Dosage Forms Produced in a Non-Sterile Setting. PDA Annual Meeting, March 2001.
  15. 15.↵
    U.S. Department of Agriculture. Hazard Analysis and Critical Control Point Principles and Application Guidelines. August 1997. Available at http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/HACCPPrinciplesApplicationGuidelines/default.htm.
  16. 16.↵
    World Health Organization (WHO). HACCP: Introducing the Hazard Analysis Critical Control Point System,WHO/FSF/FOS/97.2 (1997). Available at http://www.who.int/foodsafety/fs_management/en/intro_haccp.pdf.
  17. 17.↵
    Submission of quality information for biotechnology products in the Office of Biotechnology Products; notice of pilot program. Federal Register 2008, 73 (128), 37973.
    OpenUrl
  18. 18.↵
    1. Rathore A. S.
    Follow-on protein products: scientific issues, developments and challenges. Trends Biotechnol. 2009, 27 (12), 698–705.
    OpenUrlPubMed
  19. 19.↵
    1. Mollah A. H.,
    2. Long M,
    3. Baseman H. S.
    1. Ahmed R.,
    2. Genova T.
    Biopharmaceutical Manufacturing. In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, Mollah A. H., Long M, Baseman H. S., Eds.; John Wiley & Sons: Hoboken, NJ, 2013; pp 325–366.
  20. 20.↵
    1. Rathore A. S.,
    2. Low D.
    Managing Raw Materials in the QbD Paradigm. BioPharm Int. 2010, Part 1: Understanding Risks, 23 (11), pp 34–42; Part 2: Risk Assessment and Communication, 23 (12), pp 48–57.
  21. 21.↵
    1. Ozturk S. S,
    2. Hu W.-S.
    1. Bates R.
    Downstream Processing. In Cell Culture Technology for Pharmaceutical and Cell-Based Therapies, Ozturk S. S, Hu W.-S., Eds.; Oxford, UK: Taylor and Francis Group, LLC, 2006; pp 439–482.
  22. 22.↵
    1. Kirdar A. O.,
    2. Chen G.,
    3. Weidner J.,
    4. Rathore A. S.
    Application of near-infrared (NIR) spectroscopy and multivariate data analysis (MVDA) for screening of raw materials used in the cell culture medium for the production of a recombinant therapeutic protein. Biotechnol. Prog. 2010, 26 (2), 527–531.
    OpenUrlPubMed
  23. 23.↵
    FDA Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics, Chemistry, Manufacturing, and Controls Documentation, May 1999.
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PDA Journal of Pharmaceutical Science and Technology: 68 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 3
May/June 2014
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A Practical Discussion of Risk Management for Manufacturing of Pharmaceutical Products
A. Hamid Mollah, Harold S. Baseman, Mike Long, Anurag S. Rathore
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 271-280; DOI: 10.5731/pdajpst.2014.00975

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A Practical Discussion of Risk Management for Manufacturing of Pharmaceutical Products
A. Hamid Mollah, Harold S. Baseman, Mike Long, Anurag S. Rathore
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 271-280; DOI: 10.5731/pdajpst.2014.00975
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