Executive Summary

The Pharmaceutical industry, much like any industry regulated under the Food and Drug Administration (FDA), has an obligation to deliver products to market of the utmost level of quality and safety. Anything less and these companies risk facing recalls, losing creditability and brand equity, as well as revenue.

With the FDA cracking down on oversight and the resulting increase in regulations, there is a rising need for initiatives that will provide guidance to help enhance the scope of safety and quality within the Pharmaceuticals industry. One of these regulations is the International Conference on Harmonization (ICH) Q10 model, which describes the elements of an effective Pharmaceutical Quality Management System (QMS).

With a vision to “Develop a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science,”1 ICH Q10 provides the framework for a truly effective Pharmaceutical QMS and puts emphasis on continual improvement and management responsibility. Regional GMP requirements, ISO QMS standards, and the ICH Q7 guideline, “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” set the foundation for ICH Q10.

While not mandatory, compliance with the ICH Q10 model is indicative of a pursuit for quality and excellence within an organization. This paper will describe the best practices for implementing a Pharmaceutical Quality Management System as stated by ICH Q10 as well additional aspects of a QMS that can go above and beyond in meeting Pharmaceutical quality expectations.