Research ArticlePDA Paper

Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations

Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling and Mike Windover
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 635-647; DOI: https://doi.org/10.5731/pdajpst.2019.010645

References

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    U.S. Pharmacopeial Convention. General Chapter <1> Injections and Implanted Drug Products (Parenterals)–Product Quality Tests. In USP 41–NF 36; USP: Rockville, MD, 2018; pp 5915–5920.
  2. 2.↵
    Parenteral Drug Association. Technical Report No. 78: Particulate Matter in Oral Dosage Forms; Bethesda, MD, 2017.
  3. 3.↵
    Parenteral Drug Association. Technical Report No. 44: Quality Risk Management for Aseptic Processes; Bethesda, MD, 2008.
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    Industry Perspective on the Medical Risk of Particles in Injectable Products. PDA J. Pharm. Sci. Technol. 2015, 69 (1), 123–139.
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Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
Sylvia Anger, Cecile Begat, Vincent Crnko, GianMaurizio Fantozzi, Wadi Farach, Sean Fitzpatrick, Brian Gallagher, Stefan Huelsmann, Paul Kinsey, Vincent Langlade, Ghislain Lefevre, Elise Legendre, Kevin McLean, Jahanvi Miller, Ravi Patel, Anthony Perry, Herve Soukiassian, Amy Stanton, Dorothee Streich, Christopher Timmons, DAVID Vaneylen, Tony van Hoose, Linda Wildling, Mike Windover
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 635-647; DOI: 10.5731/pdajpst.2019.010645
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