Design Qualification (DQ) in Pharma: Aligning Equipment Design with GMP Requirements

Design Qualification (DQ) in Pharma: Aligning Equipment Design with GMP Requirements Design Qualification (DQ) in Pharma: Aligning Equipment Design with GMP Requirements Design Qualification (DQ) is the documented verification that the proposed design of a system, equipment, or facility is suitable for its intended purpose, aligns with regulatory expectations, and complies with GMP requirements. DQ is typically the first step in the equipment qualification lifecycle and plays a pivotal role in laying the foundation for successful Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This article provides a comprehensive guide for QA, Engineering, Validation, and Regulatory Affairs teams…

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