Procedure for Preparing Annual Product Quality Reviews (APQR)
| Department | Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs |
|---|---|
| SOP No. | SOP/Ointment/167 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized approach for preparing Annual Product Quality Reviews (APQR) in pharmaceutical manufacturing. The APQR evaluates the consistency of a product’s quality, identifies trends, and ensures compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
2. Scope
This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs departments responsible for compiling, reviewing, and approving APQRs.
3. Responsibilities
- QA Officer: Compiles data and prepares the APQR report.
- QC Analyst: Provides analytical and stability testing data.
- Regulatory Affairs Officer: Ensures compliance with regulatory guidelines.
- Production Supervisor: Supplies manufacturing and deviation reports.
- QA Manager: Reviews and approves the final APQR.
4. Accountability
The QA and Regulatory Managers are accountable for ensuring that all APQRs are prepared and maintained in compliance with GMP, FDA, ICH, and WHO regulations.
5. Procedure
5.1 Data Collection for APQR
The following data must be compiled for each product:
- Batch Manufacturing Records (BMR): Summary of all batches manufactured during the review period.
- QC Analytical Data: Compilation of test results,
including assay, dissolution, and microbial limits.
Deviation and CAPA Reports: Summary of all deviations, investigations, and corrective actions taken.
Stability Data: Review of stability studies and trends in product degradation.
Market Complaints and Recalls: Analysis of customer feedback, complaints, and any recalls.
Regulatory Changes: Updates on new regulatory guidelines affecting the product.
Equipment and Facility Review: Assessment of equipment performance and maintenance records.
Out-of-Specification (OOS) Reports: Summary of failed results and corrective actions taken.
5.2 Preparation of APQR Report
- The APQR must be prepared using the **APQR Report Template (Annexure-1).**
- Each section of the report must include:
- Product details (name, strength, dosage form).
- Batch summary with acceptance/rejection status.
- Statistical evaluation of test results.
- Trend analysis for deviations, CAPA, and complaints.
- Recommendations for process improvements.
- The draft APQR must be reviewed by QA and Regulatory Affairs before finalization.
5.3 Trend Analysis and Risk Assessment
- All collected data must be statistically analyzed to identify trends.
- Key areas of trend analysis include:
- Batch-to-batch variability.
- Stability trends over time.
- Increase in deviations, OOS, or market complaints.
- Any identified risks must be documented in the **Risk Assessment Report (Annexure-2).**
- Corrective actions must be recommended to address significant trends.
5.4 Review and Approval of APQR
- The completed APQR must be **reviewed by the QA Manager and Regulatory Affairs Officer.**
- Approval steps include:
- Verification of data accuracy.
- Assessment of compliance with regulatory requirements.
- Approval signatures from QA and Regulatory Heads.
- Once approved, the APQR must be archived for future audits.
5.5 Implementation of Recommendations
- If trends indicate process inefficiencies, improvement actions must be implemented.
- QA must ensure that all corrective actions are documented and tracked.
- Follow-up audits must be conducted within **six months** to verify effectiveness.
5.6 Retention Period of APQR Records
- APQR reports must be archived for **a minimum of 5 years.**
- Records must be **readily available for regulatory audits.**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- APQR – Annual Product Quality Review
- CAPA – Corrective and Preventive Action
- OOS – Out of Specification
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- APQR Report Template (Annexure-1)
- Risk Assessment Report (Annexure-2)
8. References
- ICH Q10 – Pharmaceutical Quality System
- WHO Guidelines on APQR
- US FDA Guidance on Product Quality Reviews
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: APQR Report Template
| Product Name | Batch No. | Test Results | Deviation Summary | QA Approval |
|---|---|---|---|---|
| Ointment A | OINT-1001 | Pass | None | Approved |
Annexure-2: Risk Assessment Report
| Risk Category | Identified Issue | Impact | Corrective Action | Verification |
|---|---|---|---|---|
| Process | Batch yield variability | Medium | Adjust mixing time | Verified |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Risk Assessment Section | Improved APQR Compliance | QA Head |