STANDARDIZED AND WELL STRUCTURED GMP CHECKLIST AS A VALUABLE TOOL FOR CONSISTENT AND SUCCESSFUL INTERNAL AUDIT

Edita ALILI-IDRIZI, Emilija JANEVIK IVANOVSKA, Sihana A. LIKA, Merita DAUTI, Faton AHMETI, Lulzime BALLAZHI, Drita HAVZIU

Abstract

Audit planning in the pharmaceutical industry, is the most crucial phase of the audit process, therefore it is imperative for the auditor to gain as much information in advance of this process, that should help him design tools useful in achieving the desired results. A GMP audit checklist is considered to be an invaluable and an effective tool in the implementation of an audit process. A well-prepared checklist comprises of a carefully structured series of questions that may be asked when verifying strengths and weaknesses within the organization’s control system. Therefore, this review outlines the most important sections recommended to be, at the very least, included in the GMP audit checklist. A bibliographic-research consists on analysis of review articles, original articles, guidelines, standards using the databases of PubMed, EBSCO, Scopus, Sage, Science Direct and Google Scholar. Based on the fact that GMP includes all parts of production starting from materials, equipment, documentation, storage to personnel training and hygiene, there are several sections recommended to be included in the audit checklist, such as Quality management, Personnel, Facility and Equipment System, Documentation, Production System, Packaging and Labelling System, Storage System, and Laboratory Control System. A well designed and structured checklist should enable assessment and identification of the problematic areas and possible problems, and can ensure beneficial, consistent and successful audit process and reports.

Pages: 145 - 150