Regulatory Terms Starting With Q

7 terms in the Q index.

• Q-Submission (Q-Sub)

  Q-Submission is FDA's umbrella mechanism for a device sponsor to request feedback or a meeting rather than a marketing decision, covering Pre-Submissions, Submission Issue Requests, Study Risk Determinations, and Informational Meetings.

• Qualified Person for Pharmacovigilance (QPPV)

  Qualified Person for Pharmacovigilance (QPPV) is the single named individual, resident in the EU/EEA, whom a marketing authorisation holder must have permanently and continuously at its disposal to establish and maintain its EU pharmacovigilance system.

• Quality Agreement (Quality Agreement)

  A Quality Agreement is a written cGMP contract between a drug owner and a contract facility that assigns each quality responsibility (batch release, deviation investigation, change control, audit rights) to one named party, separate from the commercial supply agreement.

• Quality by Design (QbD)

  Quality by Design is a systematic pharmaceutical development approach that fixes quality targets before experimentation, then builds product and process understanding until quality is designed into the manufacturing process rather than tested into the finished batch.

• Quality System (QS)

  Quality System is the documented management framework a regulated manufacturer uses to direct product quality across the lifecycle, distinct from GMP's minimum production rules by adding management responsibility, monitoring, and continual improvement obligations.

• Quality System Regulation (QSR)

  Quality System Regulation (QSR) was FDA's device current good manufacturing practice framework at 21 CFR Part 820, governing design and manufacture of finished devices until the Quality Management System Regulation superseded it on February 2, 2026.

• Quality Target Product Profile (QTPP)

  Quality Target Product Profile is a prospective summary of the quality characteristics a drug product must achieve, covering dosage form, strength, delivery, release and stability, from which every critical quality attribute in the control strategy is derived.