Imagen de Portada
Código QR

Automated Decision-Making Tool That Determines the Most Economic Sampling Plan for Process Validation of Pharmaceutical and Biomédical Products.

This paper proposes an automated digital system for the selection of the most cost-friendly process validation sampling plan. The system is based on the US Food and Drug Administration's mandates and other standardized procedures. The algorithm is designed to deliver one output as a function of mult...

Descripción completa

Publicado en:Journal of Validation Technology (JVT) Vol. 17; no. 4; pp. 76 - 81
Autor principal: Gola, Andres I.
Formato: tables/charts Journal Article
Publicado: Institute of Validation Technology Autumn2011
Acceso en línea:Ver este registro en EBSCOhost
fields @attributes:
  recordID: 1
pdfLink:
plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=69826312&site=ehost-live
header:
  @attributes:
    shortDbName: ccm
    uiTerm: 69826312
    longDbName: CINAHL Complete
    uiTag: AN
  controlInfo:
    bkinfo:
    dissinfo:
    jinfo:
      jid:
        10796630
        38NF
      jtl: Journal of Validation Technology (JVT)
      issn: 10796630
      maglogo: N
    pubinfo:
      dt: Autumn2011
      vid: 17
      iid: 4
      pid: 34717
      pub: Institute of Validation Technology
      place: Duluth, Minnesota
    artinfo:
      ui:
        69826312
        108212242
        108212242
        69826312
      ppf: 76
      ppct: 5
      formats:
      tig:
        atl: Automated Decision-Making Tool That Determines the Most Economic Sampling Plan for Process Validation of Pharmaceutical and Biomédical Products.
      aug:
        au: Gola, Andres I.
        affil: Quality engineer, GCI, Inc.
      sug:
        subj:
          Quality Assurance
          Technology, Pharmaceutical
          Automation
          United States Food and Drug Administration
          United States
          Algorithms
      ab: This paper proposes an automated digital system for the selection of the most cost-friendly process validation sampling plan. The system is based on the US Food and Drug Administration's mandates and other standardized procedures. The algorithm is designed to deliver one output as a function of multiple input parameters without further interaction with the users. The system will reduce any possible subjective elections and will make the output a completely objective and quantitative result.
      pubtype: Academic Journal
      doctype:
        tables/charts
        Journal Article
      ougenre: Article
    language: English
    refInfo:
    holdings:
      @attributes:
        islocal: N