Volume : 13, Issue : 07, July – 2026

Title:

IMPLEMENTATION OF CHANGE CONTROL SYSTEM IN PHARMACEUTICAL MANUFACTURING

Authors :

Sayed Shaffath Ali, I.Shruthi, Dr. Shaik Shabeer, Dr. P Poli Reddy

Abstract :

Change control is a fundamental component of pharmaceutical quality systems that ensures all modifications affecting products, processes, equipment, facilities, utilities, analytical methods, and documentation are properly evaluated, approved, implemented, and monitored. The implementation of an effective change control system in pharmaceutical manufacturing is essential for maintaining product quality, patient safety, regulatory compliance, and continuous process improvement.
This study reviews the implementation of change control practices in pharmaceutical manufacturing based on published research articles, regulatory guidelines, and industry standards. The review examines the principles, procedures, and regulatory requirements established by Good Manufacturing Practices (GMP), the World Health Organization (WHO), the United States Food and Drug Administration (USFDA), and the International Council for Harmonization (ICH). The change control process involves identification of the proposed change, risk assessment, impact evaluation, approval, implementation, verification, and post-implementation review.
The study concludes that successful implementation of change control in pharmaceutical manufacturing requires a structured quality management framework, cross-functional collaboration, comprehensive risk assessment, and adherence to regulatory expectations. A robust change control system contributes significantly to product consistency, operational efficiency, and patient safety, thereby strengthening the overall pharmaceutical quality system.

Cite This Article:

Please cite this article in press Sayed Shaffath Ali et al., Implementation Of Change Control System In Pharmaceutical Manufacturing, Indo Am. J. P. Sci, 2026; 13(07).

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