The purpose of this SOP is to provide the guidance for performing and documenting annual product reviews.
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Annual product review helps evaluate the quality of the product by reviewing all the deviation investigation, any changes in the process, validation, Recalls, customer complaints and if any change in specification. This report is reviewed by the senior management for the product quality.
1. Quality Assurance Department: Quality assurance department is responsible for the reviewing and compiling all the deviation, recalls and customer complaints.
2. Quality Control Department: Review specification to make sure it is current and review stability data to confirm expiration date.
3. Validation Department: Review process validation and determine if additional validation is required for process, equipment or method.
4. Regulatory Department: Regulatory department is responsible for providing the information on any regulatory filling for the product. Regulatory department is responsible for evaluating any specification or process change which may impact regulatory filling requirements.
5. Manufacturing Department: Manufacturing department is responsible for the complete review of manufacturing process to determine if there were any changes made to the process during the year.
Annual Product Review (APR): A periodic review of the product based on the product results, customer complaints, recalls, specification, stability data, validation and deviation.
21CFR 180 (e) Subpart J – Records and Reports
21 CFR 211.180 (e), General Requirements
21 CFR 211.192 Production Record Review
1. Annual product review (APR) should be completed on annual basis for each product manufactured by the company.
2. APR will contain information about all the batches manufactured during that period.
3. Review trends in process and finished product test data generated for the batches manufactured during that period.
4. Review stability data for evidence of chemical, microbiological, and physical degradation, and investigations concerning data discrepancies. Verify that the data confirms adequate expiration date. Also any stability trend or deviation noticed will be reported in the report.
5. A summary of all the product returned due to quality issue should be included in the annual product review.
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6. Review of all the customer complaints and determine if the complaints received represents a significant increase or decrease from the previous year. If any corrective action required due to increase in the complaints should be reported in the annual product review.
7. The retention samples based on statistical sampling procedure from each product should be visually inspected and recorded in the annual product report.
8. Validation department should report any validation performed on process, equipment or method should be included in the APR.
9. Regulatory department should provide information on regulatory submission due to change in the process or specification.
10. Review of all the deviation investigation report should be included in the report to evaluate impact on the quality of the product. Quality assurance department should compile a list of all the deviation and out of specifications.
11. The review summary should contain information on corrective actions, recommendation that resulted from the review. Quality assurances department responsible for compiling report and follow up of corrective action.
12. A conclusion will be formulated based on the overall findings from the annual review and appropriate corrective action and preventive action will be recommended.
13. Annual product report should be approved by QA, QC, Regulatory affairs, Manufacturing and Validation department.
14. All the APR’s are reviewed by the senior management for the quality of the product.
Annual product review reports are stored for seven years.
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