Product Quality Review: the full syllabus
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.
- 2.5 hours, self-paced
- Verifiable certificate with a unique ID
- Team licences available
Anyone who writes, reads or signs the review
- QA staff who compile, author or approve the PQR
- QPs, MAH quality staff and contract givers who must review PQRs written by someone else
- Production, QC and engineering leads who supply the data and own the actions
Outcomes, not topics
By the end of the course you will have done each of these on a real data set, not just read about it.
- Map every one of the twelve content areas of EU GMP 1.10 to a data source, an owner and a section of the report
- Group products, set the review period and the timeline so the report is complete before the due date
- Trend results with control charts and capability indices, and say in words what the trend means
- Write a conclusion that answers the three questions the paragraph asks and stands on its own
- Convert the conclusion into CAPA, change control and specification decisions with owners and dates
- Handle the contract manufacturer, the MAH's evaluation and the QP's use of the PQR under Annex 16 without duplicating the work
6 modules, in the order a review is built
- 1
What the PQR is for and what inspectors read first
The three purposes in EU GMP 1.10, the evaluation duty in 1.11, the API version in ICH Q7 2.5, and the page an inspector turns to before anything else: the conclusion.
Free preview: What is a Product Quality Review? Purpose, scope and what inspectors read first - 2
The twelve content areas of EU GMP 1.10, section by section
Items (i) to (xii): what each one asks, where the data lives, what a compliant section looks like and the ways each is commonly written without saying anything.
Free preview: The twelve content areas of EU GMP 1.10, explained section by section - 3
Data collection, grouping and timing
Grouping by product type, review period and cut-off dates, data pulls from LIMS, the deviation system and the stability programme, and the schedule that gets the report out on time.
Free preview: Grouping products, review periods and timing: getting the PQR out before it is late - 4
Trending and statistical evaluation that means something
Control charts, capability indices, run rules, how many batches you need, and how to write the sentence that turns a chart into a finding or a reassurance.
Free preview: Trending in the PQR: control charts, capability and what 'trend' means to an inspector - 5
Conclusions, actions and the link to CAPA and management review
Answering 'is the process consistent, are the specifications appropriate, what needs to change', writing actions with owners, and feeding the outcome into ICH Q10 management review and Annex 15 ongoing process verification.
Free preview: Writing a PQR conclusion that leads to action: CAPA, management review and ongoing process verification - 6
Contract manufacturing, the MAH and the QP
EU GMP Chapter 7 responsibilities, the quality agreement clauses that decide who writes what, the MAH's documented evaluation under 1.11, and Annex 16 and the QP's use of the PQR in certification.
Free preview: Contract manufacturers, the MAH and the QP: who writes the PQR, who evaluates it and who relies on it
Every module is tied to its clause
- EU GMP Ch. 11.10, 1.11 product quality review
- EU GMP Ch. 7Outsourced activities
- EU GMP Annex 15Ongoing process verification
- EU GMP Annex 16QP certification and the PQR
- ICH Q72.5 API product quality review
- ICH Q9 (R1)Quality risk management
- ICH Q103.2.4 and 4.1 management review
- PIC/S PE 009Chapter 1, the same paragraph
Trained people make fewer defects, close faster and stay.
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.
- 01
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.
- 02
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.
- 03
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.
- 04
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.
- 05
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.
- 06
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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Sources
- [1]Gallup (2020). The Relationship Between Engagement at Work and Organizational Outcomes: Q12 Meta-Analysis, 10th edition. 112,312 business units in 96 countries. Top-quartile business units on engagement showed 41% fewer quality defects, 81% lower absenteeism and 18% to 43% lower turnover than bottom-quartile units. Cross-industry meta-analysis. Gallup's engagement measure includes development and learning opportunities.
- [2]Bersin and Associates (2010). High-Impact Learning Culture: The 40 Best Practices for Creating an Empowered Enterprise. Organisations with a strong learning culture were 26% more able to deliver quality products, showed 37% greater employee productivity and were 46% more likely to be first to market. Cross-industry survey of about 40,000 organisations.
- [3]LinkedIn Learning (2018). Workplace Learning Report: The Rise and Responsibility of Talent Development in the New Labor Market. 94% of employees would stay longer at a company that invested in their career development. Cross-industry employee survey.
- [4]EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Part I, Chapter 2: Personnel (2013), paragraphs 2.10 to 2.13. ICH Q10 Pharmaceutical Quality System (2008), section 2.4 Resource management. The regulatory requirement for training and for assessing its effectiveness.
Against what your training budget usually buys
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 |