Quality And Guidelines

Quality Assurance in GLP Facility: Ensuring Compliance and Excellence

Our Good Laboratory Practice (GLP) facility is committed to maintaining the highest standards of quality assurance, ensuring the data integrity and reliability of our research and testing activities. Our robust Quality Management System (QMS) forms the foundation of our quality assurance program. We are dedicated to maintaining a culture of quality and compliance, ensuring the highest standards of research and testing excellence.

Key Components of Our Quality Assurance Program

1. Time Synchronization System: Ensures accurate and uniform timing across all equipment and systems.
2. Deviation and CAPA Management: Identifies, investigates, and corrects deviations, implementing corrective and preventive actions.
3. Change Control Process: Evaluates and approves changes to procedures, equipment, and systems.
4. Risk Assessment and Management: Proactively identifies and mitigates potential risks.
5. Standard Operating Procedures: Standard Operating Procedures ensure consistency and accuracy.
6. Temperature and Humidity Control: Maintains optimal environmental conditions.
7. Data quality and integrity: Ensure data is trustworthy and compliant

Compliance with Regulatory Requirements

1. OECD GLP Principles
2. ISO 9001:2015
3. 21 CFR Part 11 and Part 58
4. Other relevant regulatory requirements

Benefits of Our Quality Assurance Program

1. Ensures data integrity and accuracy.
2. Maintains compliance with regulatory requirements.
3. Enhances customer confidence.
4. Supports continuous improvement.
5. Protects data and research integrity.