Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2011 Vol: 3 Issue: 6

Conduct of Inspections for Pharmaceutical Manufactures or Importers as Per EU Guidelines

Abstract

Inspections have become a standard assessment tool deployed by regulatory authorities and standard bodies when monitoring external organizations under their remit. The objective of the present study was to document the requirements for the condition of inspection of pharmaceutical manufacturers or importers as per European Union (EU) guidelines. These guidelines provided by EU gives a general guidance on conducting inspections. The primary goal for the inspector should be to determine whether the various elements within the quality assurance system are effective and suitable for achieving compliances with GMP principles. In addition the goal is to determine that medicinal products comply with their marketing authorization. The task of an inspector is not limited to the disclosure of faults deficiencies and discrepancies. An inspection should normally include educational and motivating elements.