Examinando por Autor "Yupanqui Egoavil, Sonia Luz"

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    Propuesta de implementación de documentos técnicos para el cumplimiento de las buenas prácticas de distribución y transporte en droguerías de especialidades farmacéuticas a temperatura ambiente controlada; con base en la R. M. N.º 833-2015/MINSA
    (Universidad Privada Norbert Wiener, 2018-01-24) León Basilio, Rocio Jakeline; Yupanqui Egoavil, Sonia Luz; Rodríguez Lichtenheldt, José Edwin
    The present thesis proposed the implementation of technical documents to ensure compliance with Good Distribution and Transportation Practices in Pharmaceutical Specialty Wholesalers at controlled room temperature, in order to preserve the quality, efficacy, and safety of products during distribution and transportation, as stipulated in R.M. No. 833-2015/MINSA. The research consisted of five stages. In the first stage, the R.M. No. 833-2015/MINSA was reviewed and analyzed, and eleven points were identified for compliance with Good Distribution and Transportation Practices for Pharmaceutical Specialties at controlled room temperature. In the second stage, a Quality Manual and an Organization and Functions Manual were developed. In the third stage, Standard Operating Procedures (SOPs) were prepared. In the fourth stage, Record Formats were implemented. In the fifth stage, compliance with the requirements of R.M. No. 833-2015/MINSA was verified using a checklist. In this thesis, the implementation of the following technical documents was proposed: two manuals, twenty Standard Operating Procedures, and twenty-five Record Formats. The proposal for implementing the technical documents was carried out based on a detailed analysis and in accordance with the requirements of R.M. No. 833-2015/MINSA.