Quality Assurance Section
The Quality Assurance (QA) Section serves as the cornerstone of product integrity and regulatory compliance. It ensures that every vaccine, diagnostic reagent, and biological product manufactured by the Institute meets the highest standards of quality, safety, and efficacy in accordance with national and international guidelines.
Overview
The Quality Assurance Section is responsible for establishing and maintaining a comprehensive quality management system (QMS) encompassing every aspect of vaccine and diagnostic production. QA ensures compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and all relevant national standards.
The section also monitors documentation, validation, deviation control, and product release authorization to ensure continuous improvement and traceability.
Core Functions
- • Oversight of all GMP and GLP documentation and compliance
- • Batch record review and final product release authorization
- • Process validation and equipment qualification
- • Internal audits and corrective/preventive action (CAPA) tracking
- • Vendor qualification and material traceability monitoring
- • Staff training and competency assessment in quality systems
Quality Management System (QMS)
The QMS implemented by the QA Section covers documentation control, deviation handling, change management, and product recall procedures. Each process is designed to ensure full compliance with ISO 9001 and regulatory guidelines for veterinary biological production.
Infrastructure and Facilities
- • Dedicated QA office and document control unit
- • Secure digital archive for batch records and SOPs
- • Validation and calibration monitoring systems
- • Controlled access storage for retained samples and reference standards
Collaboration with Other Divisions
The QA Section works in close coordination with Quality Control (QC), production, and R&D divisions to ensure that all products meet predefined acceptance criteria before release. QA also participates in external audits and proficiency testing to benchmark institutional quality standards.
Commitment to Excellence
Upholding transparency, accountability, and continuous improvement, the Quality Assurance Section remains committed to delivering biological products that meet the expectations of farmers, veterinarians, and regulatory authorities alike.