Is your quality agreement fit-for-purpose?May 07, 2019
Author: Melanie Ziehm, AbbVie Quality Director
A commitment to quality is essential to deliver safe, effective products that solve serious health issues and have a remarkable impact on people’s lives. This is demonstrated through development and implementation of a robust quality system designed to meet both customer and regulatory requirements. Product realization depends on the quality system to establish and maintain a state of control while facilitating continuous improvement.
A well-designed quality system has a global scope, incorporating guidelines from all relevant markets. This assures data quality and integrity through adherence to quality standards, policies and procedures. It also allows for the identification of benefits and risks which can be made available to those involved in making quality decisions. To expedite change, flexibility within the quality system is essential.
A global quality system assures cross-site compliance
To deliver on customer objectives, contract development and manufacturing organizations (CDMOs) typically operate across multiple geographical locations, each of which can be audited by a variety of different agencies. Centers of excellence ensure the quality system remains the same globally. Improvements to the quality system are implemented worldwide with input from the center of excellence members globally to maintain cross-site consistency. A specific site may be renowned as a center of excellence for a particular manufacturing capability or may perform a dedicated function of the quality system. This highlights the importance of embedding site-specific quality requirements within the global quality system.