ViPharma APQR brings product, batch, laboratory and quality information into one structured review process — helping QA teams analyse trends, identify recurring signals, document observations and complete a controlled Annual Product Quality Review.
APQR is not simply a yearly report. It is a structured review of product and process performance used to assess consistency, identify adverse trends, review quality events and determine whether further action is required. ViPharma APQR is designed to make that review more organised, traceable and easier to analyse.
Select Product → Select Review Period → Compile Data → Analyse → Trend → Review Exceptions → Record Conclusion → Approve APQR.
Start the APQR with a controlled product and review period. The system can organise the review around a single product, defined manufacturing site and the applicable reporting period.
Maintain a structured annual review for the selected product.
Define the annual review period and control the data included.
Associate the review with the applicable manufacturing operation.
Use prior review observations and actions as part of the current review.
A strong APQR needs more than finished-product results. Market practice increasingly brings together manufacturing, laboratory, stability and quality-event information so the reviewer can assess the complete product quality picture.
Review the product across the batches manufactured during the selected period. Batch-wise visibility makes it easier to identify variability, rejected or reprocessed batches, yield changes and recurring process signals.
| Batch | Manufacturing | Yield | QC Status | OOS / OOT | Deviation |
|---|---|---|---|---|---|
| B24001 | Completed | 98.2% | Released | 0 | 1 |
| B24002 | Completed | 97.9% | Released | 0 | 0 |
| B24003 | Completed | 96.8% | Released | 1 | 2 |
| B24004 | Completed | 98.0% | Released | 0 | 0 |
The value of APQR comes from identifying movement and recurring patterns, not simply listing numbers. ViPharma APQR can present batch-wise and parameter-wise data in structured trend views for QA review.
Quality events should be reviewed in the context of the product and the annual period. ViPharma APQR can organise exception data so recurring issues, investigation outcomes and required follow-up become visible.
Review occurrence, investigation status, root cause and outcome.
Identify adverse or unusual movement before it becomes a larger signal.
Trend events by type, severity, cause and recurrence.
Review investigation conclusions and associated actions.
APQR should not stop at counting quality events. The review can assess whether corrective and preventive actions were implemented, whether recurring issues remain and whether effectiveness has been demonstrated.
Product quality review should include relevant market feedback. Complaint, return and recall information can be analysed by category, product impact, recurrence and investigation status to identify quality signals originating outside the manufacturing site.
Stability data provides a long-term view of product performance. The APQR can include stability results, time points, specification status and adverse trends as part of the overall product quality assessment.
Product quality can be influenced by process changes, analytical methods, materials, suppliers and validation status. A modern APQR brings these factors into the same annual assessment.
Review product/process-related changes and their status.
Assess relevant process and analytical validation activities.
Review material quality and supplier-related signals.
Review testing, specifications and relevant method changes.
The previous review should not disappear into an archived PDF. ViPharma APQR can carry forward observations, recommendations and open actions so the next review can evaluate their status and effectiveness.
The final APQR should convert the collected evidence into a documented quality conclusion. ViPharma APQR supports a structured review process with observations, recommendations, actions and controlled approval.
Generate a structured APQR report containing the review period, product information, batch summary, quality trends, exceptions, stability, complaints, actions, conclusions and approval information.
ViPharma APQR can be configured around electronic records, role-based access, audit trail, user accountability, controlled review and approval workflows. Final regulatory compliance depends on intended use, configuration, validation/qualification and the customer's procedures.
Bring manufacturing performance, laboratory results, stability, deviations, CAPA, complaints and change information together to support a complete annual product quality assessment.
Manual data collection, separate spreadsheets and repeated chart preparation.
Product-centred review with defined data sections and controlled workflow.
Trend, exception and action visibility to support better QA decisions.
Explore how ViPharma APQR can be configured around your products, batch data, QC results, quality events, stability programme and annual review process.
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