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Study on applying qbd approach to microbial limit tests on non-sterile pharmaceutical products

  • At: 2018 FIP Congress in Glasgow (Scotland)
  • Type: Poster
  • By: AKSU, Buket (İSTANBUL KEMERBURGAZ University, Pharmaceutical Technology)
  • Co-author(s): Buket Aksu: Faculty of Pharmacy, Altınbaş University, Istanbul, Turkey
    Gizem Yegen: Faculty of Pharmacy, Altınbaş University, Istanbul, Turkey
    Cansu Vatansever: Faculty of Pharmacy, Altınbaş University, Istanbul, Turkey
  • Abstract:

    Background

    Microorganisms can cause spoilage in pharmaceutical products and are potential hazard to patients. Thus, certain tests must be conducted to demonstrate that pharmaceutical products are within the safety microbial limits (1). In QbD (Quality by Design) studies, it is important to determine the critical quality attributes (CQAs) and

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Last update 13 May 2019

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