SOP Title: Annual Product Review
- Objective:
To lay down procedure for performing Annual Product Quality Review to verify the consistency of the process, assess trends, determine need of change in specification, production, manufacturing and/or control procedures and evaluate the need of revalidation.
- Scope:
This procedure is applicable to all the products manufactured in the plant. The data shall be used for internal review only.
- Responsibility:
QA Department: Responsible for compilation and collation of APR documents by assuring that all departments supply the required data and timeline for the receipt of data are met.
QC Department: Responsible for supply of respective data to the QA Department.
Production Department: Responsible for supply of respective data to the QA Department.
Warehouse Department: Responsible for supply of respective data to the QA Department.
- Accountability:
Head QA Department.
- Procedure:
5.1 Definitions:
Annual Product Review (APR): Annual Product Review is defined as a total study of a product, considering all the critical parameters to review the trend of analytical and process related data, change control, deviation and market complaints.
5.2 Procedure:
| 5.2.1 | Annual Product Review Procedure: Annual product review shall be product and site specific. APR shall include at least following reviews: | |
| 5.2.1.1 | Review of all the batches (Bulk, Finished Product) manufactured whether approved or rejected. | |
| 5.2.1.2 | Review of complaints, recalls, field alerts, changes including effect upon validation status, error and incident reports, returned or salvaged drug products. | |
| 5.2.1.3 | Raw Material used, if any changes in source or specification. | |
| 5.2.1.4 | Review of in-process controls and Finished Product results. | |
| 5.2.1.5 | Batch that fail to meet established specifications. | |
| 5.2.1.6 | Changes to process and analytical methods. | |
| 5.2.1.7 | Review of Marketing Authorization (MA) variations. | |
| 5.2.1.8 | Review of results for stability programme. | |
| 5.2.1.9 | Review of commitments for technical agreements. | |
| 5.2.1.10 | Non conformity, incident reports, rejects. | |
| 5.2.1.11 | Out of Specification (OOS), deviations. | |
| 5.2.1.12 | List of validated procedures and revalidation data. | |
| 5.2.1.13 | List of qualified equipment and requalification data. | |
| 5.2.1.14 | Change control. | |
| 5.2.1.15 | Responsible official’s notification. | |
| 5.2.1.16 | Product variables evaluated. | |
| 5.2.2 | The Trend Analysis Procedure: A review of trend analysis of following parameters shall be performed for finished products: | |
| 5.2.2.1 | Batch to batch variation in critical parameters for Finished Products. | |
| 5.2.2.2 | Review of product complaints, recalls, quality related returned goods, reprocess/rework of product and quality attributes. | |
| 5.2.2.3 | Evaluation of data. | |
| 5.2.2.4 | Defined alert limits. | |
| 5.2.2.5 | Documented investigation of significant variations/deviations. | |
| 5.2.2.6 | Appropriate corrective action plans/follow-up. | |
| 5.2.3. | Annual Product Review Report: The APR report shall include at least following points: | |
| 5.2.3.1 | Documentation of evaluations including summary and conclusions. | |
| 5.2.3.2 | Reviewed and approved by designated officials. | |
| 5.2.3.3 | Personnel responsible for data collection, analysis and reporting. | |
| 5.2.3.4 | Investigations not completed within the APR period shall be included in an addendum when the investigation is finalized. | |
| 5.2.3.5 | Review and approval within one months of due date, or two months if other levels of review/approval are required due to observed adverse trends. | |
| 5.2.4 | Evaluation criteria | |
| 5.2.4.1 | Valid analytical/microbiological test data (including stability test data) | |
| 5.2.4.1.1 | Review results for deviations from specifications/guidelines/standards. |
|
| 5.2.4.1.2 | Investigation of deviations /OOS. | |
| 5.2.4.1.3 | Evaluation of microbiological data (where applicable). | |
| 5.2.4.1.4 | Methods (including in-process, finished product and stability). | |
| 5.2.4.1.5 | Review of stability data for :
a. Deviations. b. Any trends showing a decrease or an increase in decomposition products. c. Evaluation of a possible need to institute an internal release specification to assure conformance to specifications throughout the shelf life. |
|
| 5.2.5 | Primary container / closure changes | |
| 5.2.5.1 | Identified specific changes. | |
| 5.2.5.2 | Evaluate effect on product quality. | |
| 5.2.6 | Formula / process changes | |
| 5.2.6.1 | Change in source or specification of Raw Material. | |
| 5.2.6.2 | Changes to formula, Raw Materials quantities, process steps, significant equipment, manufacturing conditions, packaging configurations. | |
| 5.2.6.3 | Validation data and revalidation data. | |
| 5.2.6.4 | Stability requirements for trend in potency or decomposition changes. | |
| 5.2.7 | Complaints | |
| 5.2.7.1 | Trends – quality and other technical. | |
| 5.2.7.2 | Type and number attributed to product quality. | |
| 5.2.8 | Recalls / Field Alerts | |
| 5.2.8.1 | Stock distribution, market withdrawals, field corrections, stock recoveries. | |
| 5.2.8.2 | Investigation results. | |
| 5.2.8.3 | Corrective actions. | |
| 5.2.8.4 | Reasons for recall or field alert. | |
| 5.2.9 | Product / process problems | |
| 5.2.9.1 | Manufacturing variance reports. | |
| 5.2.9.2 | Review of in-process control and Finished Product results. | |
| 5.2.9.3 | Rejection reports – (OOS results). | |
| 5.2.9.4 | Reprocessing or reworks. | |
| 5.2.9.5 | Process changes. | |
| 5.2.9.6 | Trends in production. | |
| 5.2.9.7 | Change control. | |
| 5.2.10 | Packaging | |
| 5.2.10.1 | Data on packaging from relevant Master Formula Record. | |
| 5.2.11 | Follow-up: The product quality review follow up should include: | |
| 5.2.11.1 | Responsibility of relevant personnel. | |
| 5.2.11.2 | Appropriate corrective action. | |
| 5.2.11.3 | Results and conclusion documented. | |
| 5.2.11.4 | Approval by QA and impacted areas. | |
| 5.2.11.5 | Tracked and periodically reported to management during management review meeting. |
- Abbreviation:
| Abbreviation | Expansion |
| APR | Annual Product Review |
| MA | Marketing Authorization |
| OOS | Out Of Specification |
| QAD | Quality Assurance Department |
| QAP | Quality Assurance Procedure |
| SOP | Standard Operating Procedure |
| No. | Number |
*Note – Ready to use SOP available in “DOWNLOAD” Section.