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Research ArticleCase Studies

Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment

Ruben van der Galiën, Arjan L. Langen, Leon J. M. Jacobs, Prachi Sawant Raschdorf, Annie Xing and Irene M. C. van Amsterdam
PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 208-217; DOI: https://doi.org/10.5731/pdajpst.2024-003018
Ruben van der Galiën
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
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  • For correspondence: Ruben.Galien@gehealthcare.com
Arjan L. Langen
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
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Leon J. M. Jacobs
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
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Prachi Sawant Raschdorf
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
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Annie Xing
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
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Irene M. C. van Amsterdam
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
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References

  1. 1.↵
    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 Products for Human Use. European Commission: Brussels, 2018. https://ec.europa.eu/health/system/files/2019-02/2018_annex2_en_0.pdf (Accessed July 1, 2024).
  2. 2.↵
    International Conference for Harmonisation. Harmonised Tripartate Guideline Q10: Pharmaceutical Quality System. ICH: Geneva, 2008. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf (Accessed July 1, 2024).
  3. 3.↵
    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 1, Manufacture of Sterile Medicinal Products. European Commission: Brussels, 2008. https://ec.europa.eu/health/system/files/2016-11/2008_11_25_gmp-an1_en_0.pdf (Accessed July 1, 2024).
  4. 4.↵
    1. van der Galiën R.,
    2. Langen A. L.,
    3. Jacobs L. J. M.,
    4. Hagen B.,
    5. Flahive K.,
    6. Chatterjee S. D.,
    7. van Amsterdam M. C.
    (2023) – Setup of a Contamination Control Strategy Using the Hazard Analysis Critical Control Point (HACCP) Methodology. PDA J. Pharm. Sci. Technol. 2023, 77 (4), 317–328
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    1. El Azab W.
    Contamination Control Strategy: Implementation Road Map. PDA J. Pharm. Sci. Technol. 2021, 75 (5), 445–453.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    Parenteral Drug Association Inc. Technical Report. No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing; Bethesda, MD, 2023. https://kh.aquaenergyexpo.com/wp-content/uploads/2023/06/Best-guide-for-contamination-control-strategy-CCS-.pdf (Accessed November 19, 2024).
  7. 7.↵
    ECA Task Force on Contamination Control Strategy. CCS Guideline version 2.0; 2022. https://www.scribd.com/document/628514745/20220119-ECA-Task-Force-CCS-Guideline-Vers2 (Accessed July 5, 2024).
  8. 8.↵
    International Conference for Harmonisation. Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2008. https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-quality-risk-management-step-5-first-version_en.pdf (Accessed July 5, 2024).
  9. 9.↵
    1. Sandle T.,
    2. Leavy C.,
    3. Di Mattia M.
    (2019) - Use of Hazard Analysis Critical Control Point (HACCP) Methodology for Biocontamination Control: Assessing Microbial Risks and to Determining Environmental Monitoring Locations. Eur. J. Parenter. Pharm. Sci. 2019, 243 18–45.
    OpenUrl
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    1. Gillings N.,
    2. Hjelstuen O.,
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    12. Ocak M.,
    13. Patt M.,
    14. Todde S.,
    15. Walte A.
    EANM Guideline on Quality Risk Management for Radiopharmaceuticals. Eur. J. Nucl. Med. Mol. Imaging 2022, 49 (10), 3353–3364.
    OpenUrlPubMed
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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
Ruben van der Galiën, Arjan L. Langen, Leon J. M. Jacobs, Prachi Sawant Raschdorf, Annie Xing, Irene M. C. van Amsterdam
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 208-217; DOI: 10.5731/pdajpst.2024-003018

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Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
Ruben van der Galiën, Arjan L. Langen, Leon J. M. Jacobs, Prachi Sawant Raschdorf, Annie Xing, Irene M. C. van Amsterdam
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 208-217; DOI: 10.5731/pdajpst.2024-003018
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