Regulatory Terms Starting With Q

Q-Submission (Q-Sub)

FDA's formal mechanism for device sponsors to obtain feedback on development plans, submission content, or regulatory strategy before filing.

Qualified Person for Pharmacovigilance (QPPV)

The designated EU-based individual responsible for the establishment and maintenance of a Marketing Authorization Holder's pharmacovigilance system.

Quality Agreement (Quality Agreement)

A written document defining the cGMP responsibilities and activities between a drug owner and contract manufacturer or testing facility.

Quality by Design (QbD)

A systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.

Quality System Regulation (QSR)

FDA regulations governing the methods and facilities used in the manufacture of medical devices.

Quality Target Product Profile (QTPP)

A prospective summary of the quality characteristics a drug product should possess to deliver the intended therapeutic benefit to the patient.