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Non-sterile products: Challenge test validation

  • At: 2017 FIP Congress in Stockholm (Sweden)
  • Type: Poster
  • By: PINTO, Terezinha J A (FACULDADE DE CIÊNCIAS FARMACÊUTICAS - USP, FARMÁCIA, SÃO PAULO, Brazil)
  • Co-author(s): Marina de Souza Braga: Pharmacy, Faculty of Pharmaceutical Sciences - University of São Paulo , São Paulo, Brazil
    Daniela Dal Molim Ghisleni: Pharmacy, Faculty of Pharmaceutical Sciences - University of São Paulo, São Paulo, Brazil
    Kamal Dua: School of Pharmacy and Biomedical Sciences, The University of Newcastle , Newcastle , Australia;School of Pharmaceutical Sciences, Shoolini University , Solan, India
    Antonio Felizes Pinto: Pharmacy, Faculty of Pharmaceutical Sciences - University of São Paulo , São Paulo, Brazil
    Cleide Maria de Oliveira Amaral: Pharmacy, Faculty of Pharmaceutical Sciences - University of São Paulo, São Paulo, Brazil
    Felipe Rebello Lourenço: Pharmacy, Faculty of Pharmaceutical Sciences - University of São Paulo, São Paulo, Brazil
    Rajendra Awasthi: NKBR College of Pharmacy & R. Centre , Meerut, Uttar Pradesh, India
    M. V. Ramana: Amity Institute of Pharmacy, Amity University -Lucknow , Uttar Pradesh , India
    Terezinha J A Pinto: Pharmacy, Faculty of Pharmaceutical Sciences - University of São Paulo, São Paulo, Brazil
  • Abstract:

    Backgrounds

    Production of non-sterile oral pharmaceutical products requires a focus on strict specification for microbial-quality aspects. Considering production under Good Manufacturing Practice concept, the expectation is about a product with a low level of microorganism, as detected by enumeration tests and also an absence of undesirable

    ..

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Last update 4 October 2019

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