Purpose

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.

Learning outcomes

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

What the site gets back

A PQR an inspector can read cold: every content area of EU GMP 1.10 covered, trended and concluded, reducing the chance of a Chapter 1 finding or an EudraGMDP non-compliance statement
Templates (report, data collection and trending worksheet, conclusions and action log) adopted by the team, so reviews are consistent across products and authors
A certificate with a verifiable ID for the training matrix, checkable by an auditor
Reviews that are on time and actually used: actions with owners feed CAPA, change control and management review instead of sitting in a PDF

Modules

1. What the PQR is for and what inspectors read first
2. The twelve content areas of EU GMP 1.10, section by section
3. Data collection, grouping and timing
4. Trending and statistical evaluation that means something
5. Conclusions, actions and the link to CAPA and management review
6. Contract manufacturing, the MAH and the QP

Regulatory mapping

EU GMP Ch. 1 (1.10, 1.11 product quality review); EU GMP Ch. 7 (Outsourced activities); EU GMP Annex 15 (Ongoing process verification); EU GMP Annex 16 (QP certification and the PQR); ICH Q7 (2.5 API product quality review); ICH Q9 (R1) (Quality risk management); ICH Q10 (3.2.4 and 4.1 management review); PIC/S PE 009 (Chapter 1, the same paragraph).

Cost comparison. A one-day classroom course on the PQR typically costs €900 to €1,500 per person plus travel and a day away from the site. This course is priced for the waitlist launch for two and a half hours in the learner's own time. Team licences with a manager view and completion exports are available from the academy.