Questions that arrive through the contact form, answered here so the next person does not have to ask. Each answer cites the clause. Ask your own at the bottom.
How often does management review have to happen?
No regulation sets a number. ICH Q10 asks for management review at appropriate intervals and EU GMP 1.6 says periodic. The interval is yours to define and justify in a procedure, and most sites settle on annual with an interim review at six months or quarterly.
What inspectors test is whether the interval matches the risk. A site that had a recall, a critical inspection finding or a failing supplier and waited eleven months to put it in front of senior management has not met EU GMP 1.6's 'timely and effective communication and escalation', whatever the procedure says. An interim mechanism for events that cannot wait is the practical answer.
Who must attend, and can the site head send a delegate?
The regulations name the role, not the person: senior management in ICH Q10 and EU GMP Chapters 1 and 2. The point of the clause is that the people who can commit resources and change the system are the ones who judge it.
A delegate can attend a review; a delegate cannot make the review's decisions. If the site head is routinely absent and signs the minutes afterwards, an inspector will read that as senior management not owning the system, which is a finding against ICH Q10 2.1 and EU GMP 1.5 rather than a scheduling problem. Record who attended by role, and if a required role was absent, record how the decisions were ratified.
ICH Q10 3.2.4 and 4.1 describe them without a numbered list: process performance and product quality, CAPA, change management, audits and inspections, regulatory commitments, changes in regulations and guidelines, performance indicators, and the outcome of previous reviews. EU GMP Chapter 1 expects the same ground to be covered when senior management reviews the system.
In practice a site that also covers PQR conclusions, supplier performance, validation status, training and resources will satisfy both. A review that has never discussed one of the ICH Q10 inputs is incomplete on its face, and an inspector will check the list against your minutes.
That the inputs were assessed and that decisions were made. ICH Q10 4.3(d) and EU GMP 1.6 expect the outcome to be documented and communicated, and EU GMP Chapter 4 requires the quality system to be documented. An attendance sheet and a copy of the slides prove that a meeting happened, not that anything was reviewed.
The test an inspector applies is simple: pick an input, find where the minutes say what was concluded about it and what will be done. Minutes built around 'noted' and 'presented' fail that test. Minutes that record the question each input raised, the conclusion, the decision, the owner and the date pass it. Debate and disagreement belong in the minutes too; they are the evidence that senior management judged rather than rubber-stamped.
We do a thorough PQR every year. Is that not our management review?
No. The product quality review under EU GMP 1.10, and under ICH Q7 2.5 for active substances, looks at one product or product family: its batches, specifications, deviations, changes and stability. Management review looks at the quality system as a whole: whether the processes, resources and controls that produce every product are suitable and effective. The PQR is one of the most important inputs to management review; it is not a substitute for it.
The relationship should be visible in both records. PQR conclusions and open actions go into the review pack, and decisions the review makes about a product or process are traceable back to the PQR that raised them. A site with excellent PQRs and a formality of a management review has a senior management ownership gap, not a product quality gap.
Fewer than most sites present, and each one with a target or limit, a trend rule and a question. ICH Q10 talks about process performance and product quality indicators, EU GMP 1.4 expects a state of control demonstrated through monitoring of process performance and product quality. Batch acceptance rate, product quality complaint rate and invalidated OOS rate are the three an inspector is most likely to ask for by name. Right-first-time, deviation rate by cause, CAPA on-time closure and effectiveness, complaint rate per units distributed, overdue training and audit finding closure cover most systems.
The number that matters is how many decisions the metrics produced. A pack of thirty charts that led to no decision is worse than six indicators that each raised a question the review answered. Leading indicators (overdue CAPAs, open changes without effectiveness review) are more useful to a review than lagging counts, because the review can still act on them.
ICH Q10 3.2.4 and 4.3 expect improvements to processes and products, allocation of resources, and changes to the quality policy and objectives. EU GMP 1.6 expects opportunities for improvement to be identified.
Each output has to be written as something that can be closed: an owner by name, a deliverable, a date and a way of knowing it worked. An inspector will pull the last review's outputs and ask what happened to them. 'Improve training' cannot be checked; 'training manager to bring overdue training in packaging below 5% by 31 March, reviewed at the interim review' can.
