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  • Q

    The time point at which dissolution samples are tested, as described in USP 24 NF 19 <711>

  • Q4B Outcome

    (ICH Q4B) Produced by the Q4B evaluation process; information concerning how the evaluated pharmacopeial text can be used. The Q4B Outcome is included as part of the topic-specific Q4B annex developed as a result of each favorable evaluation.

  • Q8, Q9, Q10

    ICH Guidance documents dealing with pharmaceutical development, quality risk management, and pharmaceutical quality systems, respectively.

  • QA

    Quality Assurance

  • QA

  • QA Change Control

    Process by which proposed changes to a qualified system are assessed before implementation to determine the impact on the system. Proposed changes must be approved prior to implementation.

  • QAP

    Quality Activity Plan

  • QbD

    Quality by Design

  • QbR

    Question based Review (FDA)

  • QC

    Quality Control

  • QCSC

    Quality and Compliance Subcommittee (ISPE term)

  • QM

    Quality Management

  • QMS

    Quality Management System

  • QP

    Qualified Person

  • QRM

    Quality Risk Management

  • QRMP

    Quality Risk Management Plan

  • QS

  • QSIT

    Quality System Inspection Technique (FDA medical devices)

  • QSM

    Quality Assurance and Safety of Medicines (WHO)

  • QSR

    Quality System Regulation (FDA medical devices)

  • QTPP

    Quality Target Product Profile

  • QU

    Quality Unit

  • QUA

    Formal “Quality Unit Approval” Point in C&Q

  • Qualification

    Process of demonstrating whether an entity – activity or process, product, organization, or any combination thereof – is capable of fulfilling specified requirements.

  • Qualification

    Process of demonstrating whether an entity is capable of fulfilling specified requirements.NOTE: in the context of meeting regulatory requirements, ‘qualification’ implies adherence to strict documentation requirements, reviews and approvals.