Standard Operating Procedure for Blending and Milling in Cream Formulations
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/072/2025 |
| Supersedes | SOP/CRM/072/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
This SOP outlines the process for blending and milling in cream formulations. It ensures that the ingredients are properly blended and milled to achieve uniform consistency and smooth texture in the final cream product.
2. Scope
This SOP applies to the blending and milling operations for cream formulations in the Creams Department. It covers the preparation, blending, milling, and verification of product consistency.
3. Responsibilities
- Production Team: Responsible for the operation of blending and milling equipment, ensuring correct procedures and monitoring of parameters.
- Quality Control (QC): Ensures the final cream product meets quality standards for texture, consistency, and smoothness.
- Quality Assurance (QA): Ensures GMP compliance and reviews batch records and documentation.
- Maintenance Team: Ensures all blending and milling equipment is properly maintained and calibrated.
4. Accountability
The Head of Production is accountable for ensuring that the blending and milling process is followed according to this SOP. The QA Manager is responsible for overseeing the documentation and ensuring product compliance with quality standards.
5. Procedure
5.1 Pre-Blending and Milling Preparation
- Verify that all ingredients are prepared, weighed, and ready for blending and milling.
- Ensure that all equipment, including blenders and mills, is clean and calibrated. Verify the cleanliness of mixing vessels and milling machines.
- Check the formulation record to ensure all ingredients match the required specifications for the batch being produced.
5.2 Blending Process
- Transfer the ingredients to the blending vessel, ensuring that they are added in the correct order, following the product formulation.
- Begin the blending process at a low speed to ensure thorough mixing and prevent air incorporation.
- Gradually increase the blending speed as necessary to achieve a uniform blend. Continue blending for the required time, ensuring a homogeneous mixture.
- Check the mixture for consistency, ensuring that all ingredients are evenly distributed and the mixture is free of lumps.
5.3 Milling Process
- Transfer the blended mixture to the milling machine. Set the appropriate milling speed and pressure according to the formulation requirements.
- Monitor the milling process to ensure the cream reaches the desired consistency and smoothness.
- During milling, regularly check for any signs of air bubbles, lumps, or inconsistencies. If issues are observed, stop the milling process and adjust the settings.
- Once the milling process is complete, test the consistency and texture of the cream. If the desired quality is not achieved, repeat the milling process as necessary.
5.4 Post-Milling Checks
- Perform a visual inspection of the cream for smoothness, consistency, and the absence of lumps.
- Conduct a spreadability test to ensure the product meets the required texture specifications.
- Check the product for uniformity in color and consistency. If any inconsistencies are found, take corrective action as needed.
- Record the results of the post-milling checks in the Blending and Milling Log (Annexure-1).
5.5 Documentation
- Complete all necessary documentation, including batch number, ingredients used, blending and milling parameters, and test results.
- Ensure all records are signed by the operator and reviewed by the QA team for compliance.
5.6 Final Approval
- The QA team must review all records and test results before approving the batch for the next stage of processing or packaging.
- If any deviations from the standard procedure are observed, the QA team must approve the corrective actions before proceeding with the batch.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Blending and Milling Log
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- FDA Guidelines for Cosmetics 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 Milling Log
| Batch Number | Ingredients Added | Blending Speed | Milling Speed | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | Water, Emulsifier, Stabilizer | 500 RPM | 3000 RPM | John Doe | No issues |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |