Troubleshooting in quality assurance in the pharmaceutical industry

Abstract

Quality Assurance (QA) in the pharmaceutical industry is a major pillar in preserving the quality of products and systems in place. Regional unification of standards and principles on quality, safety and efficacy is attempted through guidelines such as EU and US-FDA's cGMP. At the same time there is no standard structured approach to be applied in the practical setting to tackle challenges that arise during pharmaceutical processes. The official documents are deemed as general guides and practices in which the literature lacks reference to application in real use scenarios. In troubleshooting activities, quality guidelines are referred to according to an on-the-go basis rather than having a validated systematic framework that could be adapted to the specific situation. The aim of the research was to perform a comprehensive literature review on troubleshooting in quality assurance in the pharmaceutical industry, primarily highlighting main areas of criticality, and in turn composing and validating a general structure to be used as a guideline for QA troubleshooting in the industry. The fieldwork consisted of a retrospective analysis of a sample of QA troubleshooting occurring during three months in a pharmaceutical industry and validation of the developed framework through a focus group panel of experts representing professionals from the industry. The developed guided framework on troubleshooting in Quality Assurance can help QA personnel choose the appropriate approaches to solve problems within different departments in their firms whilst having the possibility of proactively preventing any future obstacles of similar nature.