1
tesis de grado
Publicado 2016
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In this Report of Pre Professional Practices pose, a Proposal of Standard Operating Procedure (SOP) for reporting notice of Adverse incidents(AI) and notice of adverse drug Reaction(ADR) at pharmacies , within the framework of implementation of a Management System (QMS) ISO 9001: 2008 in Pharmacies, a proposal by Angulo Alvarado P. (2010). The elaboration was divided in 6 phases: In the first phase of the establishment processes and their classification according to ISO 9001 Identified, the second included the identification of existing national laws relating to Pharmacovigilance and Pharmaceutical Technovigilance in office. Registration List of Internal and External Records and Documents, Standard Operating Procedure for Processing and Document Control, Standard Operating Procedure for reporting notice of AI and notice of suspected ADRs: In the third phase the following documents and re...