Quality in the pharmaceutical industry A literature review

Objectives: The aim of this study is to: a. Highlight the most important guidelines and practices of quality in the pharmaceutical industry. b. Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. Design: A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified: a. Research theme 1: Guidelines of the pharmaceutical quality. b. Research theme 2: General practices recently applied in the pharmaceutical industry. Main outcome measures: The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP.