Standard Operating Procedure for Reviewing Blending and Granulation Records
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/221/2025 |
| Supersedes | SOP/TAB/221/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
This SOP defines the procedure for reviewing blending and granulation records to ensure that the processes are carried out according to established specifications, regulatory requirements, and internal quality standards. The goal is to verify the consistency and quality of tablet batches.
2. Scope
This SOP applies to the review of all blending and granulation records for tablet manufacturing, covering both the R&D and production processes. It includes the documentation of materials used, process conditions, equipment parameters, and batch outcomes.
3. Responsibilities
- Production Manager: Responsible for overseeing the blending and granulation processes and ensuring the records are accurately documented and complete.
- Quality Control (QC) Team: Responsible for reviewing the blending and granulation records for compliance with specifications, identifying discrepancies, and recommending corrective actions if necessary.
- Quality Assurance (QA) Manager: Responsible for approving the final review of blending and granulation records and ensuring compliance with regulatory requirements.
- Regulatory Affairs Team: Ensures that the records meet all applicable regulatory standards and provides guidance on regulatory requirements for record retention and review.
4. Accountability
The QA Manager is accountable for ensuring that blending and granulation records are properly reviewed and that any discrepancies or non-conformances are addressed. The Production and QC teams are responsible for ensuring that the records are complete and accurate.
5. Procedure
5.1 Record Review Process
- Collect all blending and granulation records for the batch being reviewed, including raw material logs, equipment settings, process conditions, and test results (Annexure-1).
- Verify that all necessary records are present and that all fields in the records are properly completed, including date, operator details, and equipment used.
- Ensure that the materials used for blending and granulation match the approved master batch record (MBR) and that they meet the required specifications (Annexure-2).
5.2 Verification of Process Parameters
- Verify that blending and granulation process parameters (e.g., mixing time, granulation fluid volume, speed, and temperature) are within the defined limits set in the MBR (Annexure-3).
- Check that equipment used for blending and granulation is properly calibrated and maintained. Ensure that any deviations from equipment specifications are documented and addressed.
- Review batch records for any deviations from established processes or specifications, and ensure that these deviations are investigated and resolved (Annexure-4).
5.3 Review of In-Process Testing
- Review in-process testing results, such as granule size distribution, moisture content, and density, to ensure that they meet the specified criteria (Annexure-5).
- If any testing results are out of specification (OOS), ensure that a thorough investigation is conducted, and corrective actions are implemented before proceeding with the batch (Annexure-6).
- Verify that all in-process test results are documented, and any OOS results are reviewed and approved by the appropriate personnel.
5.4 Approval and Final Review
- Once the blending and granulation records are reviewed and all criteria are met, the QA team shall approve the records (Annexure-7).
- In cases where discrepancies are identified, the QA team will work with the Production and QC teams to resolve the issue and re-verify the batch records before approval.
- Document the approval of the blending and granulation records in the appropriate review log.
5.5 Documentation and Record Keeping
- Ensure that all reviewed blending and granulation records are stored securely and are easily retrievable for future audits or inspections (Annexure-8).
- Maintain records for a minimum of 5 years, or as required by applicable regulations.
- Ensure that any deviations or discrepancies are properly documented and that corrective actions are followed up and tracked (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- MBR: Master Batch Record
- OOS: Out of Specification
7. Documents
- Blending and Granulation Batch Record (Annexure-1)
- Material Log (Annexure-2)
- Process Parameter Verification Sheet (Annexure-3)
- Deviation Report (Annexure-4)
- In-Process Testing Log (Annexure-5)
- OOS Investigation Report (Annexure-6)
- Final Approval Log (Annexure-7)
- Record Retention Log (Annexure-8)
- Corrective Action Log (Annexure-9)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- GMP Guidelines for Pharmaceutical Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Blending and Granulation Batch Record
| Batch Number | Material Used | Operator | Date | Process Parameter | Result |
|---|---|---|---|---|---|
| Batch123 | API, Excipients | John Doe | 01/03/2026 | Mixing Speed | 500 rpm |
Annexure-2: Material Log
| Material | Batch Number | Supplier | Quantity |
|---|---|---|---|
| API | Batch123 | Supplier ABC | 10 kg |
Annexure-3: Process Parameter Verification Sheet
| Parameter | Specification | Result | Deviation | Corrective Action |
|---|---|---|---|---|
| Mixing Speed | 500 rpm | 500 rpm | None | None |
Annexure-4: Deviation Report
| Deviation ID | Description | Action Taken | Status |
|---|---|---|---|
| DEV001 | Tablet hardness out of spec | Reprocessed | Resolved |
Annexure-5: In-Process Testing Log
| Test | Specification | Result | Pass/Fail |
|---|---|---|---|
| Granule Size | 100-250 µm | 180 µm | Pass |
Annexure-6: OOS Investigation Report
| OOS ID | Issue | Investigation Findings | Action Taken |
|---|---|---|---|
| OOS001 | Granulation moisture out of spec | Inconsistent mixing | Reprocessed with adjusted parameters |
Annexure-7: Final Approval Log
| Batch Number | Approved By | Approval Date |
|---|---|---|
| Batch123 | John Smith | 06/03/2026 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New process | QA Head |
| 01/02/2025 | 2.0 | Added in-process testing and documentation requirements | Annual review | QA Head |