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Investigating inspection practices of pharmaceutical manufacturing facilities in selected Arab countries: views of inspectors and pharmaceutical industry employees
EMHJ-Eastern Mediterranean Health Journal. 2013; 19 (11): 919-929
em Inglês | IMEMR | ID: emr-159121
ABSTRACT
There are few studies that explore inspection practices of pharmaceutical facilities from the viewpoint of inspectors and industry employees. In this descriptive, cross-sectional study, inspectors and quality assurance staff from 4 Arab countries - the United Arab Emirates, Saudi Arabia, Egypt and Jordan - were surveyed about their inspection practices and views. There was considerable variation in inspection practices across countries and between the inspectorate and quality assurance staff within countries. Divergence was found in views associated with payment mechanisms. There was mutual agreement by both groups that inspectors were in short supply and that they needed to be better trained. Inspectors appeared to have less authority than expected in order to control pharmaceutical manufacturing and marketing activities. Compounding this was a dearth of policy which would support a more uniform and systematic approach to the inspection process within and across countries
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Índice: IMEMR (Mediterrâneo Oriental) Assunto principal: Política Pública / Garantia da Qualidade dos Cuidados de Saúde / Preparações Farmacêuticas / Estudos Transversais / Árabes / Fidelidade a Diretrizes Tipo de estudo: Estudo de prevalência Idioma: Inglês Revista: East Mediterr Health J. Ano de publicação: 2013

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Índice: IMEMR (Mediterrâneo Oriental) Assunto principal: Política Pública / Garantia da Qualidade dos Cuidados de Saúde / Preparações Farmacêuticas / Estudos Transversais / Árabes / Fidelidade a Diretrizes Tipo de estudo: Estudo de prevalência Idioma: Inglês Revista: East Mediterr Health J. Ano de publicação: 2013