Standard Operating Procedure for Product Quality Review (PQR) Preparation in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/165/2025 |
| Supersedes | SOP/API/165/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 14/04/2025 |
| Effective Date | 16/04/2025 |
| Review Date | 14/04/2026 |
1. Purpose
To establish a standard procedure for the preparation and review of Product Quality Reviews (PQRs) for all manufactured Active Pharmaceutical Ingredients (APIs), as per cGMP and regulatory requirements, to ensure consistency of the manufacturing process and continual product quality improvement.
2. Scope
This SOP applies to the Quality Assurance (QA) department responsible for the annual compilation of PQRs for each
commercial API product manufactured within the facility.
3. Responsibilities
- QA Officer: Gather and compile data from respective departments.
- Production, QC, Warehouse Heads: Provide relevant batch data, deviations, OOS, trends, and complaints.
- Regulatory Affairs: Review for impact on product filings and variation requirements.
- QA Head: Review and approve the final PQR report and trend analysis.
4. Accountability
The Head of Quality Assurance is accountable for ensuring timely preparation, completeness, accuracy, and approval of PQRs as per regulatory compliance.
5. Procedure
5.1 PQR Frequency and Planning
- PQRs must be prepared:
- Annually for each API manufactured
- Within 90 days after calendar year-end
- QA shall prepare a PQR Calendar for the year (Annexure-1) and track status.
5.2 Information to be Included in PQR
- Product Overview:
- Product name and strength
- Manufacturing license or market authorization number
- Specifications and approved shelf life
- Batch Manufacturing Data:
- Total number of batches manufactured, rejected, and released
- Yield data and process consistency trends
- Deviations and OOS:
- Batch-specific and cumulative deviation data
- Investigation summary and CAPAs
- Stability Study Results:
- Annual stability data review
- Out-of-trend results
- Complaints:
- Product quality complaints and status
- Market recalls (if any)
- Analytical Data Trends:
- Review of specifications, test methods, and significant changes
- Regulatory Changes:
- Change control or variations submitted to regulatory agencies
5.3 Data Collection and Compilation
- QA sends PQR Data Request Forms (Annexure-2) to Production, QC, Warehouse, Regulatory, and Engineering departments.
- All supporting documents and data must be submitted within 15 working days.
- QA compiles the PQR in the standardized template (Annexure-3).
5.4 Trend Analysis and Review
- Graphical representations of trends shall be included for:
- Yield
- Deviations per batch
- OOS/OOT incidents
- Complaints frequency
- Root cause evaluation and recommendations shall be documented.
- QA shall propose CAPAs or changes if trends show negative product or process impact.
5.5 PQR Approval and Archival
- Final compiled report shall be reviewed and signed by:
- QA Head
- Production Head
- Regulatory Affairs (if needed)
- One soft copy and one hard copy shall be archived in the QA records room for 5 years.
- Electronic versions shall be stored on validated servers with version control.
5.6 CAPA and Follow-up Actions
- All recommendations from the PQR shall be tracked and implemented through CAPA management.
- QA shall ensure that proposed changes, validations, or process improvements are captured in the Change Control System.
6. Abbreviations
- PQR: Product Quality Review
- QA: Quality Assurance
- QC: Quality Control
- OOS: Out of Specification
- OOT: Out of Trend
- CAPA: Corrective and Preventive Action
7. Documents
- PQR Calendar (Annexure-1)
- PQR Data Request Form (Annexure-2)
- PQR Template Format (Annexure-3)
- CAPA Tracker and Closure Sheet
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- EU GMP Part II Section 2.3 – Product Quality Review
- 21 CFR Part 211.180(e) – Annual Product Review
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: PQR Calendar
| API Name | Year | PQR Due Date | Status |
|---|---|---|---|
| Paracetamol | 2024 | 31/03/2025 | In Progress |
Annexure-2: PQR Data Request Form
| Department | Data Requested | Due Date | Submitted On |
|---|---|---|---|
| Production | Batch yield summary | 20/01/2025 | 18/01/2025 |
Annexure-3: PQR Template Format
| Section | Description |
|---|---|
| 1 | Product Information |
| 2 | Batch Summary and Yield Trends |
| 3 | Deviation and OOS Summary |
| 4 | Stability Review |
| 5 | Complaint and Recall History |
| 6 | Analytical Trend Evaluation |
| 7 | Regulatory Filing Impact |
| 8 | CAPA Summary |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 14/04/2025 | 2.0 | Updated structure and annexures | GMP Alignment | QA Head |