Importance Of Quality Management In Pharmaceutical Industry

INTRODUCTION

Pharmaceutical industry is the most astringently regulated manufacturing industry. This industry requires a system for the management of quality. Any mistake related to quality of drug product can affect the public health. Poor quality of pharmaceutical products could be health hazard and waste of money for both pharmaceutical industry as well as the consumer. A system for quality management is needed at every stage of production.

The concept of quality management system in pharmaceutical industry is based on internationally harmonized guidance ICH Q10. These guidelines are developed by the expert working group (EWG) of international conference on harmonization for registration of pharmaceuticals for human use.

1. Quality

The

This concept applies to industrial firms of all type and size, government bodies, non profit organization and sub group within an organization.

A customer is “anyone who is affected by the service, product or process”. External customer includes ultimate users and also intermediate processors as well as retailers. External customers are of prime importance. Internal customer includes divisions of a company that are provided with information or components for an assembly and also departments that provide products to each other [2]. Nobody knows what customer need or what he wants. To satisfy the customer includes providing what is needed when it’s

Only regional GMPs can not explicitly address all stage of product life cycle. The quality system elements and management responsibility described in this guideline intended to encourage the use of science and risk based approach at each lifecycle stage, thereby promoting continual improvement across the entire product life cycle.

ICH Q10 objectives

• Active product realization

To plan, implement and maintain a system that can ensure the quality of delivered product, so that the delivered product can meet the need of patient, health care professional, regulatory authority and other internal and external customers.

• Establish and maintain a state of control

To develop and use effective monitoring and control system for process performance and product quality, thereby providing assurance of continual suitability and capability of process. Quality risk management can be useful in identifying the monitoring and control