Product quality review under EU GMP
Everything you need to write a PQR that verifies consistency, trends the data and drives action under EU GMP 1.10 and 1.11, and that the QP can rely on under Annex 16. Free guides, findings and a self-check, plus the practitioner course that teaches the whole method.
6 modules · 2.5 hours, self-paced · verifiable certificate with a unique id
The first lesson of Module 1, in full. See how the course teaches before you decide.
Start the lessonTen inspection scenarios. Find out which section of your PQR would generate a finding.
Take the self-checkThe PQR report template and the approval checklist, in a working version you can use today.
Open the templatesMapped to the regulations you are inspected against
Referenced for educational context. No regulator endorses or accredits training providers.
Product quality review deficiencies appear in every published EU inspection dataset and recur in EudraGMDP non-compliance statements year after year. It is rarely because sites do not produce the document. It is because of these.
The period ended in December, the report is signed in September, and the procedure said six months. An overdue PQR is the easiest finding an inspector can write, and it says the site does not use the review.
Forty batches of assay results in a table, every one within specification, and no chart, no run rule, no statement. EU GMP 1.10 asks the review to highlight trends. A table does not.
'The process is considered to be in a state of control and the specifications remain appropriate.' Signed. Meanwhile the report itself lists nine deviations with the same cause and a stability result approaching its limit.
The MAH holds a PDF from the CMO, unsigned by anyone at the MAH, with no evaluation of whether the MAH agrees with it. Chapter 7 and 1.11 put the responsibility for that evaluation on the contract giver.
Item (ix) asks whether last year's corrective actions worked. The section says 'not applicable' or repeats last year's action list without a status. The inspector compares the two reports side by side.
The PQR is produced to have a PQR. It is never presented to management, never feeds ongoing process verification and never changes a specification, a limit or a supplier. Inspectors can tell.
Regulators treat training as part of the quality system, not a favour to staff: EU GMP Chapter 2 requires it, requires its effectiveness to be assessed, and requires the records to prove it. The evidence says the same thing in numbers. Below: what the published studies found, what it looks like on your PQR KPIs, and the clause behind it.
41%
fewer quality defects
in the most engaged teams compared with the least engaged, across 112,000 business units. Engagement and development opportunities are measured together. [1]
26%
greater ability to deliver quality products
in organisations with a strong learning culture compared with those without. [2]
37%
higher employee productivity
in the same strong-learning-culture organisations; output per person, not hours. [2]
94%
would stay longer
of employees, at a company that invests in their learning. Retention is the quality metric nobody puts on the dashboard. [3]
The PQR KPIs a trained team moves
These are the numbers a QA head reports at management review and an inspector asks for when the PQR schedule comes up. No invented percentages here: measure yours over one review cycle before and one after, and you will have your own.
PQRs completed on schedule
Measured as: % of reviews approved by the due date in the annual schedule
Higher is better
Authors who know what each section needs collect the data through the year instead of in the last month. The review is written on time and the schedule stops slipping product by product.
PQRs with a trend evaluation
Measured as: % of reviews that evaluate trends, not just tabulate results
Higher is better
Chapter 1.10 asks for a review that verifies consistency and highlights trends. Trained authors plot, compare with the previous period and say what the data means, which is what an inspector reads first.
Conclusions that resulted in an action
Measured as: % of reviews with at least one CAPA or change control raised
Higher is better
A review that finds nothing is rarely believed. Authors who interrogate the data find the drift, the recurring deviation or the supplier issue, and the conclusion becomes a record with an owner.
PQR actions closed by the next review
Measured as: % of previous-period actions verified closed
Higher is better
Chapter 1.11 requires the previous actions to be assessed. Actions written with an owner, a date and a measurable outcome get closed; vague ones roll over year after year and turn into a finding.
CMO PQRs evaluated by the MAH on time
Measured as: % of contract-manufactured products with a documented MAH evaluation
Higher is better
Chapter 1.10 places the evaluation with the MAH regardless of who writes the review. Trained MAH staff know what to check, what to challenge and how to record it under the technical agreement.
QP referrals arising from the PQR
Measured as: count per year of issues escalated to the QP from the review
Higher is better
A review that reaches the QP with a clear conclusion supports certification under Annex 16. More referrals early means fewer surprises at batch release and fewer retrospective investigations.
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Write a PQR that verifies process consistency, shows the trends, reaches a conclusion the QP can sign, and turns into actions that management review can follow up.
Hosted on The GMP Training Academy. Launching soon. People on the waitlist are notified first and get the launch price.
What the PQR is for and what inspectors read first
The twelve content areas of EU GMP 1.10, section by section
Data collection, grouping and timing
Trending and statistical evaluation that means something
Conclusions, actions and the link to CAPA and management review
Contract manufacturing, the MAH and the QP
A fair comparison with the two alternatives most sites use. If the classroom course is genuinely better for you, book it. Most of the time it is not the classroom that is the problem, it is the follow-through.
| This course | Generic GMP e-learning | One-day classroom course | |
|---|---|---|---|
| Price per person | Launch price to be announced | €40 to €90 | €900 to €1,500 plus travel |
| Time away from work | 2.5 hours, in your own time | 1 to 2 hours | 1 day |
| Written by | Practitioners who write and sign PQRs | Content agency | Varies |
| Practice on real data | Yes, three full review sections | No | Sometimes, on the day |
| Regulation cited by clause | Every module | Rarely | Usually |
| Templates you can use tomorrow | Report, trending worksheet, action log | No | Sometimes |
| Assessment and certificate | Yes, verifiable ID | Completion certificate | Attendance certificate |
| Questions answered by the author | Yes | No | On the day only |
| Access period | 12 months, with updates | Varies | None after the event |
Each guide answers one question a PQR author, a QP or an MAH reviewer actually asks, cites the clause, and shows the weak version next to the defensible one.
What EU GMP 1.10, 1.11 and ICH Q7 2.5 actually require of a PQR, the three questions every review must answer, and the page an inspector turns to before any other.
Read the guideItems (i) to (xii) of EU GMP Chapter 1 paragraph 1.10: what each asks, where the data comes from, what a compliant section says, and the ways each is commonly written without saying anything.
Read the guideHow to define the review period, when the report must be signed, when grouping by product type is scientifically justified, and the data collection plan that stops a twelve-month review taking eighteen.
Read the guideHow to turn a table of batch results into an evaluation: which chart to use, how many batches you need, what capability indices tell you, the run rules that define a trend, and the sentence that has to accompany every chart.
Read the guideHow to write the conclusion the QP will sign, how to convert findings into actions with owners and dates, and how the PQR feeds ICH Q10 management review and Annex 15 ongoing process verification.
Read the guideThe responsibilities of the contract giver and contract acceptor under EU GMP Chapter 7, what the quality agreement must say about the PQR, the MAH's obligation to evaluate it under 1.11, and how the certifying QP uses the PQR under Annex 16.
Read the guide10 scenario questions, each with the clause behind the answer. About eight minutes. No sign-up. You get a readiness band and the modules that would close your gaps.
The finished product assay section of a PQR presents a table of 41 results, every one within the 95.0 to 105.0 per cent specification, followed by 'all results conform; the process is in a state of control'. An inspector reads it. What is the most likely observation?
Answer and explanation in the self-check.
What the inspector wrote, why, and what would have prevented it. The fastest way to learn what gets cited.
Product quality review: no evaluation of trends in finished product or in-process results
The Product Quality Review for Product X (PQR-25-011) presented finished product and critical in-process results for 40 batches in tabular form with a conformance column. No control charts, control limits, capability assessment or comparison with the previous review period were included for any parameter. The review concluded that 'the process remains in a validated state of control'. On review of the tabulated data, dissolution at 30 minutes had declined from a mean of 91 per cent in the first quarter to 84 per cent in the fourth quarter against a limit of not less than 80 per cent. This trend was not identified in the review.
Read the breakdownProduct quality review: not conducted in a timely manner; no documented extension
Site procedure QA-SOP-042 requires the approved Product Quality Review to be issued within six months of the end of the review period. At the time of inspection, the reviews for four of the site's eleven products for the period ending 31 December of the previous year had not been approved, the latest being nine months beyond the procedural deadline. No deviation, extension or risk assessment had been raised for any of the four. The QP responsible for certification of these products was not aware that the reviews were outstanding.
Read the breakdownProduct quality review: results not evaluated; no assessment of need for CAPA or revalidation
The Product Quality Review for Product Y (PQR-25-004) recorded twelve deviations during the period, of which eight related to tablet weight variation at compression on line C, a stability study in which the principal degradant had reached 0.42 per cent at 18 months against a shelf-life limit of 0.5 per cent, and two complaints of chipped tablets. The conclusion stated that 'the process is considered to be in a state of control, the specifications remain appropriate and no corrective or preventive actions are required'. The conclusion was identical in wording to that of the previous year's review. No assessment of whether CAPA or revalidation was required had been documented.
Read the breakdownThe course was not written from a syllabus. It was written from what EU regulators publish about product quality reviews that fail, then worked back to the practice that would have prevented it.
EudraGMDP non-compliance statements
Published statements of non-compliance with GMP where the PQR, the MAH's evaluation of it or the contract manufacturer arrangement is cited: late reviews, no trend evaluation, conclusions that do not follow from the data.
EMA and national competent authority inspection findings
Deficiency analyses and inspection reports published by EU national authorities, in which Chapter 1 findings on the product quality review recur every year, alongside EMA GMP/GDP Inspectors Working Group Q&As on the review and the MAH's role.
EU GMP Chapter 1, Chapter 7, Annex 15 and Annex 16
Paragraphs 1.10 and 1.11 for the review itself, Chapter 7 for the contract giver's duty to assess the acceptor's records, Annex 15 section 5 for ongoing process verification and Annex 16 for what the certifying QP relies on.
PIC/S and ICH guidance
PE 009 Chapter 1, ICH Q7 2.5, ICH Q10 3.2.4, ICH Q9 (R1) and ICH Q8 (R2), all adopted in the EU, for the expectations behind the findings.
Reviews read in consultancy and audits
Anonymised PQRs from EU and PIC/S sites, used to build the practice reviews and the weak-versus-defensible examples.
Tap a term. The full glossary has 35 terms, grouped by stage of the process.
Open the glossaryTo an inspector: any pattern in plotted data over time that a defined rule identifies. A shift in the mean, a change in spread, a drift, a run on one side of the centre line, or a result outside the process's demonstrated range.
EU GMP Chapter 1, 1.10
Seat licences for the department or the site, a manager view of progress, and completion records exported for your training matrix. Content can be mapped to your SOP numbers on request.
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A short breakdown of a real inspection finding, what went wrong and what would have prevented it. Unsubscribe in one click.
6 modules, real data, a report template you will use for the next review, and a certificate your training matrix can reference. Launching soon. People on the waitlist are notified first and get the launch price.