Both EU GMP and ICH Q10 expect a record of management review. ICH Q10 4.3(d) expects the outcome of the review to be documented and communicated. EU GMP 1.6 does not say 'record', but Chapter 4 makes every part of the quality system a documented one, and an inspector cannot assess a review they cannot read. The record is not an afterthought to the review. It is the only evidence the review happened, and the only evidence of what senior management knew and decided.
What the minutes must show
Minutes that record attendance, list the agenda and attach the slides prove that a meeting took place. They do not prove that anything was reviewed. The test an inspector applies is simple: from the minutes alone, could I tell what the review concluded about each input, and why? If the answer is no, the review is a formality on paper regardless of what happened in the room.
- Date, duration, chair, attendees and apologies, checked against the quorum in the procedure.
- Confirmation that every input on the register was presented, with a cross-reference to the pack. Where an input was not available, say so and say why.
- For each input: the key finding, the discussion in enough detail to show challenge, and the outcome: a decision, an action, or an explicit decision to take no action with the reason.
- The review's conclusion on the suitability, adequacy and effectiveness of the system, in those words, with its basis.
- Resource decisions, including requests declined and the risk accepted.
- Quality objectives for the coming period and any change to the quality policy.
- The action list with identifier, owner, date, resources and effectiveness measure.
- Approval by the chair, dated, within a defined time of the meeting.
The action log
Actions from management review need the same control as CAPAs: a unique identifier, an owner, a due date, a status, documented extensions with rationale and approval, and closure with attached evidence. Keep them in a log that persists between reviews, so that the first item at every review is the status of every open action and the effectiveness of every closed one. An inspector will ask for this log by name. If it does not exist, or if it exists only as a slide in each year's deck, the follow-up input required by ICH Q10 3.2.4(c) cannot be shown.
Effectiveness of previous actions
Closing an action is not the same as the action working. Each closed action should be reported at a subsequent review with the metric it was meant to move and what the metric did. If the line 3 counter was replaced in November and the labelling reconciliation deviation rate fell from 11 per quarter to 2, say so. If it did not fall, say that too, and reopen the question. This is the loop that turns management review into the continual improvement EU GMP 1.6 and ICH Q10 4.4 describe, and it is the record that most convincingly shows the review has consequences.
The link to PQR and CAPA
EU GMP 1.10 requires periodic product quality reviews for each product and 1.11 requires the results to be evaluated, with an assessment of whether corrective and preventive action or revalidation is needed and with management procedures for the ongoing management and review of those actions. ICH Q7 2.5 requires the same regular quality review for active substances. The PQR is a product-level review; the management review is system-level. The records should reference each other: the management review minutes should record the PQR programme status and the conclusions that affect the system, and PQR actions should appear in the same log or a log the review sees. An inspector who finds a PQR trend that never reached management review, or a management review that never mentions the PQR programme, will cite the gap under 1.6 or 1.11.
The same applies to CAPA. Actions from the review that require a change to a procedure, process or system should be raised as CAPAs or changes in the normal systems, cross-referenced from the review log, so that the review's decisions are carried out under the same controls as everything else.
What the inspector reads first
In a typical inspection, management review comes up in one of two ways. Either the inspector asks for the last two years of management review records as part of the quality system tour, or they arrive at management review from a problem: a trend, a repeated deviation, a late CAPA, and ask whether senior management knew. In both cases, the reading order is the same.
- The procedure: interval, inputs, outputs, quorum, records. Does the site know what it has committed to?
- The dates: were the reviews held at the interval the procedure requires, and were any unscheduled reviews triggered when something serious happened?
- Attendance against the organisation chart: was senior management present, in person?
- The inputs against the register: is anything missing, and is any input a count with no trend?
- The outputs: decisions, resources, actions with owners and dates.
- The action log: were the previous actions closed, with evidence, and did they work?
- The specific problem, if there was one: does it appear in a pack, and what was decided?
The findings sites actually receive
The wording varies by agency but the substance recurs. No evidence that senior management was aware of a significant quality issue. Management review did not include required inputs, most often supplier performance, the status of previous actions, or resources. Management review actions with no owner, no date or no evidence of completion. Management review held less frequently than the procedure required, or the procedure not defining a frequency. Management review records consisting of presentation slides with no record of discussion or decision. Each of these is a finding against the quality system, not against a procedure, and each is avoidable with the record described above.
Module 6 of the course provides the minutes template and action log, works through two years of a site's review records as an inspector would, and finishes with a practical exercise: present two years of reviews to an inspector in ten minutes.