Each guide answers one question a PQR author, a QP or an MAH reviewer actually asks, cites the regulation, and shows the weak version next to the defensible one. Read them in module order or jump to the one you need today.
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.
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