How to Prepare SOP for Annual Product Quality Review in GMP

What should be included in product quality review SOP?

Following are some steps and business rules you can follow while developing your standard operating procedure on annual product quality review process.

A. Annual product quality review should be completed on annual basis for each product manufactured by your company.

B. Annual product quality review will contain information about all the batches of products manufactured during that period. If you have similar product range, you may group those products into a family with similar formulation and properties.

C. Include a segment for trend review of manufacturing process and finished product test data generated for number of batches manufactured during that period.

D. Include a section for stability data review to collect evidence of chemical, microbiological, and physical degradation and investigations concerning data discrepancies. You should be able to verify that the data confirms the registered expiration date. Also any stability trend or deviation noticed during review should be detailed in the report.

E. A summary of all the product returned due to quality issue should be included in the annual product quality review SOP. A review of market activity should include all quality-related product returns, complaints and recalls. 

F. The SOP should include details on complaint investigations and recommended corrective and preventive action list. Review involves determination if the customer 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. A summary of all complaints or adverse events during the review period is required.  Details of how each issue was resolved should be provided.

G. The retention samples based on statistical sampling procedure from each product should be visually inspected and recorded in the annual product quality review report.

H. Validation department should report any validation performed on process, equipment or method should be included in the annual product quality review report. All Validation / Qualification studies either commenced or completed in the review period must be assessed.  These may include:

– Process validation

– Packaging validation

– Cleaning validation

– Analytical method validation

– Equipment validation

I. Any significant issues and deviation that were identified must be discussed and a resolution provided. The effectiveness of the validation must be determined.

J. Regulatory department should provide information on regulatory submission due to change in the process or specification. A summary of changes, in terms of specification registered with local or international government regulators must be included. Any post marketing commitments should be reviewed and status assessed.

K. The SOP should cover review of all the deviation investigation 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 investigations.

L. The review summary should contain information on corrective and preventive actions, recommendation that resulted from the review. Quality assurances department is responsible for compiling all corrective actions and implement fixes.

M. A conclusion will be formulated based on the overall findings from the annual review and appropriate corrective action and preventive action will be recommended.

N. Annual product quality review report should be approved by QA, QC, Regulatory affairs, Manufacturing and Validation department.

 All the annual product review reports should be reviewed by the senior management for the quality of the product.

How to document summary report on annual product quality review

The SOP for annual product quality review should details how to collect, analyse and report data and information to provide a complete picture on product quality, any departure from expectations and corrective actions to be taken to prevent the degradation. The summary report of annual product quality review should provide a comprehensive overview of the data contained within the different elements of the product review.

The summary needs to provide:

– An analysis of the products performance

– A review of all the elements reported

– A summary of any trends or concerns

– Identification of any previous issues or corrective actions

– A conclusion as to suitability of the product for on-going production

– A rating of product performance based on the report

The summary should stand alone as a report and provide sufficient detail for a senior management to make an assessment on product performance.

Conclusion

The main objective to develop an SOP for annual product quality review is to provide a consistent approach on product quality review process.

You should have standard operating procedure and templates that will describe how to review individual aspects of product quality and tending of your product quality.

The review analysis should cover areas such as production process, product specifications, major deviations, out of specification results, validation status, test methods and test results, stability studies, change of raw materials and packaging components, complaints, recalls and other market and regulatory actions.

You must prepare a comprehensive summary report of your findings and observations derived from the review. Use statistical analysis to prove if the product quality is maintaining its expected quality. If you discover any adverse trend during the review process take necessary corrective and preventive actions. Prepare your recommendations to improve the product quality in your summary report.