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
Arjan L. Langen
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
Leon J. M. Jacobs
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
Prachi Sawant Raschdorf
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
Annie Xing
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands
Irene M. C. van Amsterdam
1General Electric Healthcare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands

References
- 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.↵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.↵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.↵
- van der Galiën R.,
- Langen A. L.,
- Jacobs L. J. M.,
- Hagen B.,
- Flahive K.,
- Chatterjee S. D.,
- van Amsterdam M. C.
- 5.↵
- El Azab W.
- 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.↵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.↵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.↵
- Sandle T.,
- Leavy C.,
- Di Mattia M.
- 10.↵
- Gillings N.,
- Hjelstuen O.,
- Behe M.,
- Decristoforo C.,
- Elsinga P. H.,
- Ferrari V.,
- Kiss O. C.,
- Kolenc P.,
- Koziorowski J.,
- Laverman P.,
- Mindt T. L.,
- Ocak M.,
- Patt M.,
- Todde S.,
- Walte A.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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
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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