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Research ArticleTechnology/Application

Setup of a Contamination Control Strategy Using the Hazard Analysis Critical Control Point (HACCP) Methodology

R van der Galiën, A. L. Langen, L. J. M. Jacobs, B. Hagen, K. Flahive, S. D. Chatterjee and M. C. van Amsterdam
PDA Journal of Pharmaceutical Science and Technology July 2023, 77 (4) 317-328; DOI: https://doi.org/10.5731/pdajpst.2022.012783
R van der Galiën
1General Electric HealthCare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands;
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  • For correspondence: Ruben.Galien@ge.com
A. L. Langen
1General Electric HealthCare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands;
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L. J. M. Jacobs
1General Electric HealthCare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands;
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B. Hagen
2General Electric HealthCare AS., Nycoveien 1, 0485 Oslo, Norway; and
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K. Flahive
3General Electric HealthCare, IDA Business Park, Carrigtwohill, Ireland
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S. D. Chatterjee
1General Electric HealthCare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands;
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M. C. van Amsterdam
1General Electric HealthCare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands;
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  • Article
  • Figures & Data
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References

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    European Commission, Eudralex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 2, Manufacture of Biological Active Substances and Medicinal Product for Human Use. https://ec.europa.eu/health/system/files/2019-02/2018_annex2_en_0.pdf (Accessed May 2, 2022).
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    European Medicines Agency. ICH Guideline Q9 on Quality Risk Management. EMA/CHMP/ICH/24235/2006. https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdf (Accessed May 3, 2022).
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    Developing an Effective Contamination Control Strategy. Pharm. Tech. 2019, 43 (9), 57–58. http://www.pharmtech.com/developing-effective-contamination-control-strategy-0.
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PDA Journal of Pharmaceutical Science and Technology: 77 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 4
July/August 2023
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Setup of a Contamination Control Strategy Using the Hazard Analysis Critical Control Point (HACCP) Methodology
R van der Galiën, A. L. Langen, L. J. M. Jacobs, B. Hagen, K. Flahive, S. D. Chatterjee, M. C. van Amsterdam
PDA Journal of Pharmaceutical Science and Technology Jul 2023, 77 (4) 317-328; DOI: 10.5731/pdajpst.2022.012783

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Setup of a Contamination Control Strategy Using the Hazard Analysis Critical Control Point (HACCP) Methodology
R van der Galiën, A. L. Langen, L. J. M. Jacobs, B. Hagen, K. Flahive, S. D. Chatterjee, M. C. van Amsterdam
PDA Journal of Pharmaceutical Science and Technology Jul 2023, 77 (4) 317-328; DOI: 10.5731/pdajpst.2022.012783
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Keywords

  • Contamination Control Strategy
  • Critical Control Point
  • FMEA
  • HACCP
  • Annex 1
  • Sterility assurance

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