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Run: Annual Product Quality Review (APR/PQR) Inspection Template

Annual Product Quality Review (APR/PQR) Inspection Template helps you compile batch, deviation, complaint, stability, and trend data into one controlled annu...

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Review Scope and Product Identification

Product name, dosage form, strength, and site are identified critical (required)

Review period is clearly defined as the last 12 months critical (required)

Note (optional)

Data sources included in scope are listed critical (required)

Review owner and approver are assigned critical (required)

Batch Manufacturing and Yield Review

Total batches manufactured and released are summarized critical (required)

Note (optional)

Batch rejection, rejection rate, and reasons are documented critical (required)

Yield trend remains within established process expectations critical (required)

Any significant batch-to-batch variability is explained critical (required)

Critical process parameters remained within validated ranges critical (required)

Yes No N/A

Deviations, Investigations, and CAPA

Total deviations are summarized by type and severity critical (required)

Recurring deviations are identified and trended critical (required)

Yes No N/A

Investigations were completed within required timelines critical (required)

Yes No N/A

Root cause analysis supports the conclusions reached critical (required)

CAPA effectiveness was verified for closed actions critical (required)

Yes No N/A

Complaints, Returns, and Product Quality Signals

Complaint count and complaint rate are summarized critical (required)

Note (optional)

Complaint categories are trended by defect type critical (required)

Note (optional)

Serious or critical complaints were escalated and assessed for impact critical (required)

Yes No N/A

Returned product was reviewed for quality impact and disposition

Yes No N/A

Complaint trend indicates no unresolved product quality signal critical (required)

Trend Analysis, Stability, and Process Consistency

Key quality metrics were trended over the review period critical (required)

Note (optional)

Stability data support continued product quality critical (required)

Yes No N/A

No adverse trend indicates loss of process control critical (required)

Any out-of-trend or out-of-specification signals were investigated critical (required)

Yes No N/A

Conclusion and Approval

Overall conclusion states whether the process remains in a state of control critical (required)

Note (optional)

Required actions, owners, and due dates are documented critical (required)

Quality and manufacturing approval signatures are captured critical (required)

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