Abstract

EVALUATING THE EFFECTIVENESS OF CURRENT OUT OF SPECIFICATION INVESTIGATION TECHNIQUES AND PROCEDURES IN PREVENTING BATCH FAILURE

Deepthi Mathew*, Preethu P. John, Prof. Dr. Santhosh M. Mathews and Sinci Saji

ABSTRACT

In the pharmaceutical and manufacturing industries, maintaining batch quality and preventing batch failures are critical for ensuring product safety and regulatory compliance. The intention of Regulatory Authorities is to safeguard the patients and avert them from receive sub-standard drugs, this encourages pharmaceutical professionals to think constantly about producing quality drug and drug products. Out of Specification (OOS) results are events that pose a significant risk to batch integrity. It necessitates thorough Out of Specification investigations, corrective and preventive actions. This project aims to evaluate the effectiveness of existing OOS investigation techniques and procedures in preventing batch failure. The study involves a comprehensive review of current industry practices, regulatory guidelines and scientific literature related to OOS Investigations. Key factors contributing to batch failures are analysed in this study including equipment malfunctions, operator errors and environmental variations. A case study approach is used to evaluate the effectiveness of existing OOS investigation techniques and procedures. Some cases of batch failure incidents are analysed focusing on the investigational processes and subsequent corrective and preventive actions taken. The outcomes and effectiveness of these actions in preventing future failures will be assessed. Thus the findings of this research will contribute to the understanding of the strengths of current OOS investigation techniques and procedures.

Keywords: Quality Management Systems, Deviations, Change Control, Out of Specification (OOS), Quality Risk Assessment, Corrective and Preventive Action (CAPA), Investigation Tools and Techniques, Root Cause Analysis (RCA).