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.