Standard Operating Procedure for Granulation Process for Immediate Release Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/001/2025 |
| Supersedes | SOP/TAB/001/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 15/02/2025 |
| Effective Date | 20/02/2025 |
| Review Date | 15/02/2026 |
1. Purpose
To establish the granulation process for immediate release tablets, ensuring uniformity, stability, and compliance with GMP requirements.
2. Scope
This SOP applies to the granulation of immediate release tablets, covering raw material handling, equipment setup, and granule preparation.
3. Responsibilities
- Manufacturing Personnel: Follow instructions for equipment setup, material handling, and process execution.
- QC: Conduct in-process checks and ensure the granules meet quality specifications.
- QA: Ensure compliance with SOP and review batch records for approval.
4. Accountability
The Production Manager is responsible for implementation; the QA Manager ensures compliance and approval.
5. Procedure
5.1 Receiving and Preliminary Inspection
- Inspect all raw materials upon receipt.
- Verify packaging, labeling, and documentation such as Certificates of Analysis (CoA).
- Store materials under specified conditions.
5.2 Equipment Setup
- Inspect and calibrate the granulation equipment, including the mixer and dryer.
- Ensure all instruments (e.g., moisture analyzers, sieves) are in working order.
5.3 Granulation Process
- Load the
dry powder mixture (API and excipients) into the granulator.
Prepare and add the binder solution to the powder mixture while stirring continuously.
Granulate the mixture until the desired granule size is achieved. Adjust parameters like speed, time, and binder addition based on the material’s response during the process.
Ensure uniform wetting of the powder blend to form uniform granules. Continue mixing until the mixture reaches the required consistency, as per the formulation specifications.
Verify the process by monitoring granule size using a sieve or particle size analyzer. Continue adjusting as necessary to ensure uniformity.
5.4 Screening and Drying
- Screen the granulated mixture to ensure uniformity of granule size. Discard oversized or undersized granules.
- Dry the granules in the fluidized bed dryer, checking moisture content regularly with a moisture analyzer to achieve the desired moisture level.
5.5 Final Quality Control
- Perform particle size distribution analysis and moisture content tests on the granules.
- Ensure granules meet the required quality specifications for use in tablet compression.
- Take necessary corrective actions if any parameters fall outside acceptable limits.
5.6 Documentation and Record-Keeping
- Record all process parameters in the batch record, including mixing times, binder amounts, and granule characteristics.
- Log in-process checks and test results in the QC Log (Annexure-1), ensuring traceability of all batch details.
- Maintain batch records for reference during future production runs or audits.
6. Abbreviations
- SOP: Standard Operating Procedure
- API: Active Pharmaceutical Ingredient
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CoA: Certificate of Analysis
7. Documents
- Granulation Batch Record (Annexure-1)
- Granule Quality Control Log (Annexure-2)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Granulation Batch Record
| Batch Number | Material Name | Binder Solution | Granulation Parameters | Test Results | Remarks |
|---|---|---|---|---|---|
| Batch 001 | Material A | Starch Solution | Mixing Time: 30 mins, Speed: 250 rpm | Moisture: 4.5%, Size Distribution: 80% < 500 µm | Within Specifications |
| Batch 002 | Material B | PVP Solution | Mixing Time: 40 mins, Speed: 300 rpm | Moisture: 5.2%, Size Distribution: 75% < 500 µm | Minor Deviations |
Annexure-2: Granule Quality Control Log
| Batch Number | Test Performed | Result | Test Date | QC Personnel |
|---|---|---|---|---|
| Batch 001 | Particle Size | Pass | 15/02/2025 | John Doe |
| Batch 002 | Moisture Content | Pass | 16/02/2025 | Jane Smith |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated Process Parameters | Standardization of Granulation Process | QA Head |