2 - Quality assurance and control

Abstract

This chapter explains that within the pharmaceutical manufacturing environment, the various functions related to quality management are critical. It deals with two of the three main functions: quality assurance (QA) and quality control (QC). The third element, good manufacturing practice (GMP) is also discussed. This topic is potentially confusing because of the need to understand the difference between quality management, QA, and QC. Quality management, with the overall policy of the organization toward quality, comes above everything else. Next comes quality assurance, which is the unit that ensures the policy is achieved. GMP is a part of quality assurance; it deals with the risks that cannot be tested and builds quality into the product. Quality control is a part of GMP: the part that is focused on testing of the environment and facilities, as well as the testing of the materials, components, and product in accordance with the standard. Quality management, with the overall policy of the organization toward quality, comes above everything else.