Glossary

Say what the inspector means

The vocabulary of management review, grouped by stage of the review cycle. Definitions are ours; the source clause is given where one exists.

Responsibility

Management review: The periodic review by senior management of the operation of the quality system, to decide whether it is suitable, adequate and effective and to identify opportunities for improvement. Defined by its participants and its outputs, not by its name.EU GMP 1.6; ICH Q10 2.6, 3.2.4, 4.1
Senior management: The person or group who directs and controls the site or company at the highest level, with ultimate responsibility for the quality system and for providing its resources. The site head and their direct reports at a manufacturing site.EU GMP 1.5, 2.1; ICH Q10 2.1
Pharmaceutical quality system (PQS): The management system that directs and controls a pharmaceutical company with regard to quality, as described in ICH Q10 and required by EU GMP Chapter 1. Management review is one of its four elements alongside process performance and product quality monitoring, CAPA, and change management.EU GMP 1.4; ICH Q10 1.1 and 3.2
Quality policy: Senior management's statement of intentions and direction on quality, which the review periodically confirms or revises. Objectives should be traceable to it.ICH Q10 2.2
Quality objectives: Measurable goals set by senior management to implement the quality policy, cascaded to the relevant functions, and reported against at the review. An objective that cannot be measured cannot be reviewed.ICH Q10 2.3

Inputs

Review inputs: The information the review must consider, as listed in ICH Q10 3.2.4 and 4.1. Put it into one register so a missing input is visible before the meeting.ICH Q10 3.2.4, 4.1
Input pack: The document set circulated before the review, compiled against the input register, containing each input with its trend, comparison, reasons and the decision requested. The pack is the evidence of what senior management was shown.
Product quality review (PQR): The periodic or rolling review of each authorised product required by EU GMP 1.10, covering starting materials, critical process controls, batches, deviations, changes, stability, complaints, recalls and more. A product-level review whose conclusions are an input to the system-level management review.EU GMP 1.10 and 1.11; PIC/S PE 009 Ch. 1
PQR follow-up: The evaluation of PQR results that EU GMP 1.11 requires: an assessment of whether corrective and preventive action or revalidation is needed, with reasons documented and the actions completed in a timely and effective manner under management procedures. The management review sees the status of that follow-up, not the PQRs themselves.EU GMP 1.11; ICH Q7 2.5
Status of previous actions: The first input at every review: each action from the last review, its owner, its status and, where closed, the evidence that it worked. Its absence is one of the two most common input findings.ICH Q10 3.2.4(c)
Supplier and outsourced activity performance: Rejections, supplier deviations, audit status, quality agreement status and watch-list suppliers, presented as an input because senior management is responsible for outsourced activities and purchased materials.ICH Q10 2.7 and 4.1(b); EU GMP Chapter 7
Regulatory commitments: Undertakings given to an authority in response to inspection findings or in a submission. ICH Q10 asks the review to consider them alongside inspection results; an unmet commitment is a finding in its own right.ICH Q10 3.2.4(a)
Internal and external factors: Emerging regulations and guidance, innovations, changes in the business and its objectives, and changes in product ownership, which ICH Q10 asks the review to monitor because they change what the system has to cope with.ICH Q10 4.2
Resource adequacy: Headcount against plan, vacancy duration, overtime and backlog in quality-critical functions, presented so that senior management can exercise its responsibility to provide adequate resources. The input most often omitted.EU GMP 1.5, 2.1; ICH Q10 2.4

Metrics

Performance indicator: A measurable parameter used to quantify quality objectives and the performance of a process, which the review assesses. ICH Q10 names the processes to measure but leaves the choice of indicator to the site.ICH Q10 glossary and 4.1(b)
State of control: The condition EU GMP 1.4 requires the pharmaceutical quality system to establish and maintain through effective monitoring and control of process performance and product quality. The metrics presented at the review are the site's evidence that the state of control exists; ICH Q10 3.2.1 describes the monitoring system that produces them.EU GMP 1.4; ICH Q10 3.2.1 and glossary
Leading indicator: A measure that predicts future quality outcomes: overdue CAPAs, overdue training, validation reviews past due, QC backlog, unfilled vacancies. Reviews that use only lagging indicators are reviewing history.
Lagging indicator: A measure of what has already gone wrong: complaints, recalls, rejected batches, inspection findings. Necessary, but too late to prevent the event it records.
Trend rule: A written condition that turns a graph into a trigger, such as three consecutive periods above target or any period above the upper limit, and that places the metric on the review agenda automatically.ICH Q10 3.2.1; EU GMP 1.10
Rate versus count: A count changes with production volume; a rate (per batch, per million units, as a proportion of open items) does not. Present rates at review so the trend reflects quality rather than throughput.
Ageing: The distribution of open records (deviations, CAPAs, changes, overdue training) by time open. The most useful leading indicator and almost always a resources conversation.

Meeting

Planned interval: The frequency of review set in the site's procedure. The regulations say periodic; the number is yours to justify. Missing your own interval is a departure from procedure.EU GMP 1.6; PIC/S PE 009 1.6
Unscheduled review: A review triggered outside the planned interval by a defined event: recall, critical finding, regulatory warning, serious supplier failure, data integrity event, change in ownership. The mechanism that makes escalation timely.EU GMP 1.6; ICH Q10 2.6
Quorum: The minimum attendance, defined in the procedure, without which the review is rescheduled rather than held. It should name the chair and the functions required, and the record should show it was met.
Escalation: The defined route and time by which a quality issue moves from the point of detection to the level of management able to decide on it, and by which decisions travel back down. Management review sits at the top of the chain and depends on the levels below it.EU GMP 1.6; ICH Q10 2.5 and 4.3(d)
Decision rule: The agenda convention that every input ends in a minuted decision, an action with owner and date, or an explicit decision to take no action with the reason. 'Noted' is not a permitted outcome.
Quality culture: The shared attitudes and behaviours that determine whether problems are reported, investigated and escalated. Inspectors read it from the review record: whether bad news is presented plainly and answered with decisions.ICH Q10 2.1 and 2.5

Outputs and records

Review outputs: What the review must produce: decisions on the suitability, adequacy and effectiveness of the system and its processes, resource needs and allocation, improvement actions, and changes to the quality policy and objectives.ICH Q10 3.2.4, 4.3
Suitability, adequacy and effectiveness: The three conclusions the review must reach about the system. Suitable: fit for the organisation's purpose. Adequate: sufficient to meet requirements. Effective: producing the intended results. State the conclusion in these words, with its basis.ICH Q10 2.6
Action log: The persistent record of review actions, with identifier, owner, due date, status, extensions with rationale and closure with evidence, held under the same discipline as CAPA. The first item at every review.ICH Q10 3.2.4(c)
Effectiveness of actions: Evidence, reported at a subsequent review, that a closed action moved the metric it was meant to move. Closure is not effectiveness.ICH Q10 3.2.2 and 4.4
Minutes: The record of the review: attendance against quorum, each input with its finding, discussion and outcome, the conclusion on the system, resource decisions, objectives, the action list and the chair's dated approval. Slides and an attendance sheet are not minutes.EU GMP Chapter 4; ICH Q10 4.3(d)