Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
An effective change management system should consider the risk to quality when evaluating proposed changes specially to current products in the market and how they are authorized. This should also apply to processes that have a continuous improvement plan to reduce variability, enhance product quality and quality systems, improve process efficiency, and increase the ability to consistently meet quality needs. These changes should be implemented by teams of experts with extensive knowledge of the products or processes so that their effectiveness may be adequately monitored.
Specific to the Pharmaceutical industry, ICH Q8, Q9, and Q10 show how to maximize benefits from continuous improvement and effective changes by optimizing science and risk based post-approval change processes. After a triggering event, combining these regulations offers a path toward making a process improvement by performing with a risk assessment, collecting data for the critical parameters, assessing the variation, changing the process as need, and monitoring the improvement. Effectively implementing changes and improvements can vastly improve the consistency and quality of a product.
If you need support for implementing successful change control to improve product quality, the experts at EMMA International can help! Call us at 248-987-4497 or email us at info@emmainternational.com to learn more.
Doyle PhD, B. (2011, September 30). ICH Q10 and change management: Enabling Quality Improvement. Retrieved March 21, 2023, from https://www.fda.gov/media/85281/download