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What is ORA Laboratory Quality Policies Manual about?

This document provides quality policies for laboratories within the Office of Regulatory Affairs (ORA) of the Food and Drug Administration (FDA). It discusses the organization of ORA laboratories, management system requirements, and technical requirements for testing. Specifically, it: 1) Explains that ORA laboratories must meet the requirements of ISO/IEC 17025 and outlines the organizational structure, including responsibilities of laboratory management. 2) Details the quality policy statement and requ

Author

Sundarapandiyan Sundaramoorthy

Language

EN