Quality Management in the Pharmaceutical Industry

Quality Management in the Pharmaceutical Industry

Author: Dr Prateek Goyal , Mansarovar Global University, Bhopal

Introduction

In the Pharmaceutical Industry, Quality Management is defined as the crucial part of management function that determines and implements the management’s policy, i.e., the overall intention and direction of an organization regarding quality, as formally voiced and sanctioned by senior management.

The key elements of quality management are:

• Quality Policy and Objectives
• Quality Manual
• Organizational Structure and Responsibilities
• Internal Processes
• Customer Satisfaction with Product Quality
• Continuous Improvement
• Document Control
• Quality Management System

The entirety of these actions is termed as ‘Quality Assurance’.

Within an organization, quality assurance serves as a management tool. The concepts of quality assurance, GMP and quality control are unified aspects of quality management. The management of manufacturing organization must ensure that the quality of the pharmaceutical products fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of these quality objectives is the responsibility of senior management and requires the participation and commitment of all levels within the organization.