Standard Operating Procedure for Lubrication of Tablet Granules
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/006/2025 |
| Supersedes | SOP/TAB/006/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 10/03/2025 |
| Effective Date | 15/03/2025 |
| Review Date | 10/03/2026 |
1. Purpose
To establish a standardized method for the lubrication of tablet granules to ensure smooth tablet compression, preventing sticking and improving tablet flowability during the compression process.
2. Scope
This SOP covers the lubrication of tablet granules in the tablet manufacturing process, including the selection, preparation, and application of lubricants to the granules.
3. Responsibilities
- Manufacturing Personnel: Responsible for applying the lubricant correctly, ensuring proper mixing, and handling the granules as per the SOP.
- Quality Control (QC): Ensure that the lubricant is properly applied and the granules meet the required quality specifications.
- Quality Assurance (QA): Oversee compliance with this SOP and ensure that all procedures are followed according to GMP standards.
4. Accountability
The Production Manager is accountable for ensuring the proper application of lubricant to the granules. The QA Manager ensures the process adheres to the SOP and GMP standards.
5. Procedure
5.1 Selection of Lubricant
- Choose an appropriate lubricant based on the formulation requirements. Common lubricants include magnesium stearate,
stearic acid, or talc.
Ensure that the lubricant is compatible with the active pharmaceutical ingredient (API) and excipients, and confirm that it is approved for use by quality assurance.
Verify the batch number, Certificate of Analysis (CoA), and expiration date of the lubricant before use.
5.2 Lubricant Preparation
- Weigh the appropriate amount of lubricant as per the formulation requirements.
- If required, dissolve or disperse the lubricant in a small amount of a suitable solvent or mixture, ensuring uniform consistency.
- Ensure that the lubricant is prepared at the correct temperature, if applicable, as per the formulation guidelines.
5.3 Lubrication Process
- Transfer the lubricant to the granules in a manner that ensures even distribution. This can be done using a suitable blending equipment like a high shear mixer or ribbon blender.
- Blend the granules and lubricant for the prescribed time, ensuring that the lubricant is uniformly distributed throughout the granule mass.
- Ensure that the mixing speed and time are optimized to avoid over-lubrication or under-lubrication, which can affect tablet compression or granule flow.
5.4 In-Process Quality Control
- Monitor the lubrication process by checking the uniformity of the granules for consistency in appearance and texture.
- Perform a test on a sample of the lubricated granules to check the flow properties and ensure that they meet the specifications for compression.
- If the granules fail the QC checks (e.g., poor flow properties, irregular texture), adjust the lubrication process, such as increasing mixing time or adjusting the lubricant concentration.
5.5 Lubrication Verification
- Verify the final granule mixture by performing a quality check, including flowability tests (e.g., Carr’s index, angle of repose) and moisture content.
- Document the results of all quality checks in the batch record and QC log (Annexure-1).
5.6 Equipment Cleaning
- After completing the lubrication process, clean all equipment, including mixers, granulation pans, and containers, according to the cleaning SOP to prevent cross-contamination.
- Ensure that all lubricant residues are removed from equipment surfaces to avoid contamination of subsequent batches.
5.7 Documentation and Record-Keeping
- Record the complete lubrication process in the batch record, including the lubricant batch number, quantities used, and any deviations from the standard procedure.
- Ensure that all in-process checks, such as flowability tests, are documented and signed off by the responsible personnel.
- Ensure that all records are stored according to regulatory requirements for traceability and future reference.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CoA: Certificate of Analysis
7. Documents
- Lubrication 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: Lubrication Batch Record
| Batch Number | Lubricant Type | Amount Used | Lubrication Time | Lubrication Method | Granule Flow Properties | Remarks |
|---|---|---|---|---|---|---|
| Batch 001 | Magnesium Stearate | 3 kg | 15 minutes | Mechanical Mixing | Good Flow | Within specifications |
| Batch 002 | Magnesium Stearate | 4 kg | 12 minutes | Manual Mixing | Moderate Flow | Adjusted mixing time |
Annexure-2: Granule Quality Control Log
| Batch Number | Test Performed | Result | Test Date | QC Personnel |
|---|---|---|---|---|
| Batch 001 | Flowability | Pass | 10/03/2025 | John Doe |
| Batch 002 | Moisture Content | Pass | 11/03/2025 | 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 Lubricant Application Method | Optimization of Lubrication Process | QA Head |