The templates the course is built on
Structure and guidance for every section, free. The sections that carry the most weight in an inspection show their heading and a summary here; the full guidance, the worked examples and the editable files are in the course.
PQR report
The full review of a product or product group for the period, structured so that every content area of EU GMP 1.10 has a section, every section reaches a statement, the 1.11 evaluation is documented, and the conclusion can be checked against the body by an inspector who was not there.
1. Scope, period and grouping
Product or product group with the grouping rationale, presentations and strengths covered, manufacturing and packaging sites, review period with cut-off dates, batches manufactured, released, rejected and reworked, and the due date from the procedure.
- Why are these products reviewed together, and does the grouping still hold?
- Which batches fall inside the period, and which were deliberately excluded and why?
- When is the report due, and was it delivered on time?
2. Review of previous actions (item ix)
Full version in the courseEvery action from the previous review with its current status, evidence of completion and whether it was effective. Open actions carried forward with a reason.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
3. Starting materials and packaging materials (item i)
Suppliers used, changes in supplier, results against specification, supplier-related deviations and complaints. New suppliers and supply chain changes flagged for the specification review.
4. Critical in-process controls and finished product results (item ii)
Full version in the courseEach critical attribute trended: control chart or equivalent, capability index, run rules applied, and a sentence per attribute saying what the data shows.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
5. Out-of-specification batches, deviations and CAPA effectiveness (items iii, iv)
Full version in the courseEvery OOS and OOT with its investigation reference and disposition, significant deviations by category and root cause, repeat causes identified, CAPA raised and the effectiveness evidence for each. Not a count: a pattern with a statement.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
6. Changes, variations and post-marketing commitments (items v, vi, xi)
Each process or method change with its classification and implementation date, variations submitted, granted, refused and pending including third countries, and post-marketing commitments, all checked against the batch data in the trends.
7. Stability programme and adverse trends (item vii)
Ongoing studies, results against shelf-life specification, any adverse trend and the projected time to fail. Link to item (ii) trends where the same attribute drifts.
8. Returns, complaints, recalls and investigations (item viii)
Quality-related returns, complaints by category with rate per batch or units distributed, recalls, and the investigations that followed. Trend against previous periods.
9. Equipment and utilities qualification status (item x)
Qualification, calibration and maintenance status of the critical equipment and utilities used for the product, with any overdue items and their risk assessment.
10. Conclusion and actions (item xii and the three questions)
Full version in the courseIs the process consistent, are the specifications appropriate, what needs to change. Every statement referenced to a section. Actions with owners, dates and the system they are raised in.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
11. Contract arrangements, MAH evaluation and approvals
Full version in the courseTechnical agreement clauses under Chapter 7 that govern who writes and who evaluates, the MAH's own documented assessment of the review under 1.11, the certifying QP's confirmation under Annex 16 that the review supports continued certification, and the signatures: author, QA, QP, MAH, with dates consistent with the due date.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Data collection and trending worksheet
A structured way to plan the data pulls before the period ends, record where each data set came from, and produce trends that carry a statement rather than a table.
Data request register
One row per content area of 1.10: the system the data lives in (LIMS, deviation system, change control, stability, complaints), the owner, the query or report used, the extraction date and who checked it against the source.
- Which system is the source of truth for each item, and has it changed in the period?
- Who can pull the data, and when will they have it?
- How will the extraction be verified against the source?
Batch list and inclusion rules
Every batch in the period with its status. Rules for reworked, rejected, validation and stability batches stated once and applied consistently.
Attribute table
For each critical attribute: specification, number of results, mean, standard deviation, minimum and maximum, and the chart it feeds. Attributes with fewer than the minimum batch count flagged for a different treatment.
Control chart and run rules
Full version in the courseChart type by data type, limits derived from the data rather than the specification, the run rules applied, and the batches that triggered them.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Capability and the sentence that follows
Full version in the courseCpk or Ppk per attribute with the threshold the site uses, and the one sentence that turns the number into a finding, a reassurance or a question for the investigation.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Cross-item links
Full version in the courseWhere a trend in item (ii) coincides with a change in item (v), a supplier change in item (i) or a stability trend in item (vii). These links are what the review is for.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
PQR conclusions and action log
Turns the review's verdict into actions that can be tracked, so that next year's item (ix) has something to report and management review has something to follow up.
The three answers
Consistency, specification appropriateness and improvements, each answered in one or two sentences with the section reference that carries the evidence.
- Could this paragraph be pasted into another product's review unchanged?
- Does every statement point at a section, a chart or a number?
- Does the body contain anything the conclusion does not mention?
Action register
Each action, the finding or trend it addresses, the system it is raised in (CAPA, change control, specification review, supplier action), owner, target date and the reference number.
Specification and limit review
Full version in the courseFor each attribute: are the limits still appropriate given the data, and if a change is proposed, the regulatory route (variation, internal alert limit) and the owner.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Inputs to management review and ongoing process verification
Full version in the courseWhat from this review goes to the ICH Q10 management review and the Annex 15 ongoing process verification programme, in what form, and by when.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Follow-up and next-period check
How the status of each action will be evidenced in next year's item (ix), and who confirms it before the next report is drafted.
10 sections are summarised above. The course opens all of them.
When the course opens you get the three templates as editable files, every section with full guidance and worked examples, three complete practice reviews, the assessment and the certificate. 2.5 hours, self-paced.