Standard Operating Procedure for Binder Preparation for Granulation Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/004/2025 |
| Supersedes | SOP/TAB/004/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 01/03/2025 |
| Effective Date | 05/03/2025 |
| Review Date | 01/03/2026 |
1. Purpose
The purpose of this SOP is to define the process for preparing the binder solution used in the granulation of tablets. It ensures that the binder is prepared in a consistent manner, meeting the required quality standards and facilitating uniform granule formation.
2. Scope
This SOP applies to the preparation of binder solutions used in tablet granulation processes. It covers the materials, equipment, and procedures required for binder preparation.
3. Responsibilities
- Manufacturing Personnel: Responsible for the accurate preparation of the binder solution according to the formulation and ensuring that all equipment is set up and calibrated correctly.
- Quality Control (QC): Responsible for verifying the quality of the binder solution, ensuring compliance with specifications, and testing the binder for consistency and performance.
- Quality Assurance (QA): Responsible for ensuring compliance with this SOP and overseeing batch record reviews and approvals.
4. Accountability
The Production Manager is accountable for the preparation of the binder solution. The QA Manager is responsible for ensuring adherence to this SOP and regulatory requirements.
5. Procedure
5.1 Material Verification
- Verify the required binder materials are available and meet the specified quality standards. Materials should be approved by the quality assurance team and should be from approved vendors.
- Check the batch numbers, Certificates of Analysis (CoA), and storage conditions of all raw materials.
5.2 Binder Solution Preparation
- Calculate the required amount of binder solution based on the batch size and formulation requirements.
- Measure the appropriate quantity of the binder material (e.g., PVP, starch solution, or any other binder) according to the formulation recipe.
- Heat the solvent (usually water or an alcohol-based solution) to the required temperature as per the formulation guidelines. Ensure that the temperature is within the range specified in the formulation procedure.
- Add the binder material to the solvent while stirring continuously. Ensure the binder material is fully dissolved or dispersed as required.
- Monitor the viscosity of the binder solution to ensure it is within the desired specifications. If necessary, adjust the concentration by adding more binder material or solvent.
5.3 Binder Solution Homogeneity
- Ensure that the binder solution is homogeneous by stirring continuously. If necessary, use an agitator or mixing equipment to achieve a uniform solution.
- Check for the absence of lumps, undissolved particles, or air bubbles in the binder solution.
5.4 Quality Control Checks
- Take a sample of the binder solution for quality control testing. Perform tests such as viscosity, pH, and appearance checks to confirm that the solution meets the required specifications.
- If the solution passes all quality control tests, it is ready for use in the granulation process.
- If the solution fails any test, investigate the issue and rework the solution if necessary, or prepare a fresh batch.
5.5 Equipment Cleaning
- Clean all equipment used in the binder preparation process, including mixing tanks, pumps, and measuring instruments, as per the equipment cleaning SOP.
- Ensure that no binder residues are left in the equipment to prevent cross-contamination in future batches.
5.6 Documentation and Record-Keeping
- Document all activities in the batch record, including material lot numbers, preparation conditions (e.g., temperature, time), and any deviations.
- Sign off on the batch record to confirm that the binder solution was prepared according to the SOP.
6. Abbreviations
- SOP: Standard Operating Procedure
- CoA: Certificate of Analysis
- QC: Quality Control
- QA: Quality Assurance
7. Documents
- Binder Solution Batch Record (Annexure-1)
- Quality Control Test Results (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: Binder Solution Batch Record
| Batch Number | Binder Type | Solvent Used | Preparation Temperature | Viscosity | Quality Control Test Results |
|---|---|---|---|---|---|
| Batch 001 | PVP | Water | 60°C | 50 cps | Pass |
| Batch 002 | Starch | Water | 65°C | 55 cps | Pass |
Annexure-2: Quality Control Test Results
| Test | Specification | Result | Remarks |
|---|---|---|---|
| Viscosity | 40-60 cps | 50 cps | Within Specification |
| pH | 5-7 | 6 | Within Specification |
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 Binder Specifications | Standardization of Binder Preparation Process | QA Head |