Handling OOS Test Results and Robust Investigations

When regulatory authorities audit drug manufacturers, one of the most common issues they uncover is the inadequate investigation of failures, particularly those arising from Out of Specification (OOS) results. Authorities expect thorough investigations to uncover non-compliance, followed by effective interventions and a review of those interventions' success. Without a proper investigation and root cause analysis (RCA), organizations struggle to implement successful corrective actions, often wasting significant resources on ineffective solutions.

Many manufacturers face challenges complying with FDA, EU GMP, and WHO standards regarding Corrective and Preventive Actions (CAPA). Given that CAPA impacts nearly every facet of manufacturing operations, it's essential for all employees to understand the fundamentals—what CAPA is, why it matters, and how it works. However, simplifying the complexities of failure investigations and CAPA can be a daunting task, especially when non-compliance issues escalate to severe regulatory concerns.

WHY YOU SHOULD ATTEND:

Current Regulators expectations is that “A firm’s primary goals in investigating a Failure incident should include both discovering its cause and ensuring it does not reoccur”.

Regulators now expect that manufacturers prioritize discovering the cause of a failure and ensuring it doesn’t reoccur. This advanced training focuses on Out of Specification (OOS) failures, failure investigations, and root cause analysis (RCA), providing participants with the skills to conduct thorough investigations that reveal the true cause and develop CAPA strategies that prevent recurrence. This course also delves into current regulatory expectations regarding failure investigations, RCA, and implementing CAPA to improve Good Manufacturing Practices (GMP) and Quality Control (QC) systems.

AREAS COVERED IN THE SESSION:

• Introduction
• Determining Potential Product Impact through OOS investigation
• The Investigation – Trigger (OOS-How from day to day today analysis)
• Root Cause Analysis –Flow with Investigation Tools
• RCA Tools with Case studies
• Documentation of OOS with Phase-wise check list, (Failure Investigation Report)
• Handling of OOS-Investigations. A detailed SOP with OOS form
• Corrective and Preventive Action
• Tracking and Trending
• Recent OOS Regulatory agencies cited examples by USFDA/MHRA
• Key Elements of the Investigation Report (RCA Report)
• Questions and answer section

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• All API and Formulation Companies

Course Director: G. Sundar

G. Sundar is a quality practitioner with vast 35 years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA, Japan guidelines. He has conducted more than 200 GMP/GLP audits including Q10 & Q11 implementation, 50 Formulation Contract Manufacturing Units (all types of formulations), 10 Contract Research and Analytical laboratories, 10 Clinical research CROs. He has also conducted 1000 plus trainings Asia, US, EU, Middle East and South-East Asia. Mr. Sundar Ganesan is the Director and Senior Consultant at PharmQA Compliance Services.