Implementation of a Change Control Process in a Pharmaceutical Industry

Abstract

The pharmaceutical industry is monitored by the highest regulatory bodies such as the Food and Drug Administration (FDA) and other agencies to ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). The quality of the product is demonstrated through data generated within the process and supporting documentation. The data should demonstrate consistency, accuracy and completeness for data integrity. At the same time the equipment, process and systems should be validated for the intended use. This project focuses on the implementation of a change control in a validated system emphasizing in the required documentation to demonstrate the system has the capacity to function as it is intended and continues to meet regulatory standards. Additionally, the project provides a solution to a problem that has the potential to have data integrity issues. Key Terms ⎯ Change Control, Computer System Validation, Pharmaceutical Industry.