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Designated Person

Meaning

Within the context of regulatory affairs, particularly concerning pharmaceutical compounding or clinical trial oversight, a “Designated Person” is an individual formally appointed and legally accountable for ensuring strict adherence to specific quality, safety, and regulatory standards. This person is assigned a defined role with clear, non-transferable responsibilities, often encompassing the oversight of product integrity, meticulous documentation, and compliance with Good Manufacturing Practices (GMP) or other governing health guidelines. Their authority is essential for maintaining the highest standards of patient safety and product efficacy.