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

doi:10.5731/pdajpst.2022.012783

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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vol. 77 no. 4 317-328

DOI

https://doi.org/10.5731/pdajpst.2022.012783

PubMed

37188535

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online August 11, 2023.

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previous version (May 15, 2023 - 11:52).
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Author Information

R van der Galiën¹,*,
A. L. Langen¹,
L. J. M. Jacobs¹,
B. Hagen²,
K. Flahive³,
S. D. Chatterjee¹ and
M. C. van Amsterdam¹

¹General Electric HealthCare B.V., De Rondom 8, 5612 AP Eindhoven, The Netherlands;
²General Electric HealthCare AS., Nycoveien 1, 0485 Oslo, Norway; and
³General Electric HealthCare, IDA Business Park, Carrigtwohill, Ireland

↵*Corresponding Author: De Rondom 8, 5612 AP Eindhoven, The Netherlands; Telephone: +31681371581, E-mail: Ruben.Galien{at}ge.com

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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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