An examination of the influence that quality risk management has in the pharmaceutical manufacturing process

Abstract

The objective of this research is to examine the influence that quality risk management has in the pharmaceutical manufacturing process. This dissertation focusses on investigating how Quality Risk Management techniques are currently applied in the pharmaceutical manufacturing process and to investigate how the Quality Risk Management tools and techniques impact the efficiency of pharmaceutical products. The primary research was carried out through a survey questionnaire in many pharmaceutical industries. This research produced a number of key findings. The recent survey confirmed that quality risk management has a good influence in meeting pharmaceutical product requirements which are patient safeguard and product quality. There are several regulations which the pharmaceutical manufacturing process must follow in order to guarantee that the product is fit for purpose. Good manufacturing practices (GMP) are one of the regulations which ensure the product is consistently produced according to specifications. However, in order to meet GMP demands pharmaceutical industries must apply a quality risk management framework. The main conclusions drawn from this research were that the current tools and techniques approaches are efficient as they guarantee risk mitigation and quality assurance for the end products.