Annual Product Records Review
Introduction
This document provides guidance in the performance of annual product record reviews to evaluate data and trending to:
- Verify consistency of the process,
- Identify the need to modify specifications, and
- Identify any preventive or corrective actions that would lead to product quality improvements.
1. Data from Production Batches/Lots of all APIs and Marketed Drug Products, including Quarantined-HOLD and Rejected batches/lots, should be summarized on, at least, an annual basis. The criteria used to identify the first and last batch in the review period should be defined in Site procedures [e.g., Manufacture Date, Quality Control (QC) testing date, final disposition].
A representative number of batches that corresponds to the entire number of batches produced (including quarantined-hold and rejected batches) may be used for the Annual Product Records Review.
If less than three (3) lots are manufactured in a review period, the Annual Product Records Review may be delayed until, at least, three (3) lots are available for evaluation unless required otherwise by the governing Regulatory Team for the marketed product.
2. For Multi-Site Product Processing (i.e., manufacturing, testing, packaging), each Site Quality Team should be responsible for completing the Annual Product Records Reviews for the processing step(s) performed at that Site. Annual Product Records Reviews may be made available to other Sites upon request.
3. Annual Product Records Review Summaries should include, and are not limited to:
- Summaries of the findings described in the supporting data;
- A review of action items identified throughout the year as well as outstanding issues from the previous year;
- Recommendations for preventive or corrective actions that would lead to product quality improvements;
- An action plan, which includes responsibilities and a target completion date for each recommended action;
- Current status of any corrective or preventive action that was identified during the previous Annual Product Records Review; and
- Conclusion summarizing the current state of control for the product under review.
4. The Site Quality Team should ensure that the:
- Required data are assembled;
- Data are reviewed;
- Adverse trends in the data are identified and investigated;
- Findings and conclusions in the Annual Product Records Review are summarized;
- Review date schedule is adhered to;
- Action items identified throughout the year as well as outstanding issues from the previous year are reviewed;
- Recommendations for preventive or corrective actions that would lead to product quality improvements are provided; and
- Action plan which includes responsibilities and a target completion date for each recommended action is completed.
The Site Quality Team should sign the Annual Product Records Review as the preparer.
5. Each Production and Quality Department Head should be responsible for:
- Providing Annual Product Records Review Supporting Data generated in their departments to the Site Quality Team for inclusion in the Annual Product Records Review;
- Ensuring that the data is trended, if applicable; and
- Ensuring that any departmental-level conclusions based upon the data are accurate.
6. The Site Quality Head should:
- Review the Annual Product Records Review;
- Make or endorse recommendations, if necessary, for preventive or corrective actions that would lead to product quality improvements; and
- Identify or endorse an action plan, if necessary, which includes responsibilities and target completion dates for each recommended action.
7. The Site Quality Head and the Production Team should review and approve the Summary of the Annual Product Records Review and forward the approved Summary to the Site Quality Team for distribution and follow-up. Where required by local regulations, the Qualified Person should also review the Summary of the Annual Product Records Review to ensure that the reviews are performed and the data are accurate.
8. The Site Quality Team should:
- Forward a copy of the approved Annual Product Records Review to the Site Quality Head and Key Site Principals;
- Track progress on any recommendations; and
- Provide periodic notification of status of recommendations to the Site Quality Head