Standard Operating Procedure for Stirring Techniques in Cream Manufacturing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/073/2025 |
| Supersedes | SOP/CRM/073/2022 |
| 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 describes the proper stirring techniques for cream manufacturing. It ensures that the ingredients are properly blended to achieve uniform consistency, prevent air incorporation, and maintain the desired product quality.
2. Scope
This SOP applies to all cream formulations requiring stirring during the manufacturing process. It covers the correct techniques for stirring ingredients to ensure proper texture, homogeneity, and stability of the final product.
3. Responsibilities
- Production Team: Responsible for performing stirring operations according to the specified techniques and ensuring proper mixing of ingredients.
- Quality Control (QC): Ensures that the product meets the required consistency and texture after stirring and verifies that the process parameters are followed.
- Quality Assurance (QA): Ensures that the stirring process follows GMP standards and reviews documentation to ensure compliance.
- Maintenance Team: Ensures that all stirring equipment is maintained, calibrated, and functioning properly.
4. Accountability
The Head of Production is responsible for ensuring that the stirring techniques are followed as per this SOP. The QA Manager is responsible for reviewing the stirring process records and ensuring compliance with quality standards.
5. Procedure
5.1 Pre-Stirring Preparation
- Verify that all ingredients required for the cream formulation are available and properly weighed.
- Ensure that the mixing vessel is clean, dry, and free of contaminants.
- Ensure that all stirring equipment, such as mixing blades or paddles, is clean and calibrated.
- Check the formulation record to ensure that all ingredients are correctly listed and ready for mixing.
5.2 Stirring Process
- Place the ingredients into the mixing vessel in the specified order, as per the formulation.
- Begin stirring at a low speed to combine the ingredients gently. Gradually increase the stirring speed as the mixture becomes more uniform.
- Ensure that the stirring process is done slowly and steadily to avoid introducing air bubbles into the product.
- Monitor the mixture’s texture and consistency throughout the stirring process to ensure the proper formation of the cream.
- Continue stirring for the required time to achieve the desired texture and consistency. Periodically stop the mixer to check the mixture for uniformity.
5.3 Post-Stirring Checks
- Once the stirring process is complete, visually inspect the product for consistency, smoothness, and uniformity.
- Conduct a spreadability test to ensure that the cream meets the required texture and consistency.
- If the cream does not meet the specifications, repeat the stirring process or adjust the stirring parameters as needed.
- Document the batch number, stirring parameters (time, speed), and any observations during the stirring process in the Stirring Log (Annexure-1).
5.4 Environmental Monitoring
- Ensure that the stirring is performed under the appropriate temperature and humidity conditions as specified by the formulation.
- Monitor the environment for any deviations in temperature or humidity that may affect the stirring process or product quality.
- Record environmental conditions during the stirring process in the Environmental Monitoring Log (Annexure-2).
5.5 Documentation and Record Keeping
- Complete all relevant documentation, including the Stirring Log (Annexure-1), with details on batch numbers, stirring time, speed, and observations.
- Ensure that all records are signed by the operator and reviewed by QA to confirm compliance with the SOP and GMP standards.
5.6 Final Approval
- The QA team must review the stirring records and confirm that the batch has met all specifications before allowing it to move to the next stage of manufacturing or packaging.
- If any deviations occur during the stirring process, they must be investigated and documented in the Deviation Report Form (Annexure-3).
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Stirring Log
- Annexure-2: Environmental Monitoring Log
- Annexure-3: Deviation Report Form
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: Stirring Log
| Batch Number | Stirring Time | Stirring Speed | Operator | Comments |
|---|---|---|---|---|
| 12345 | 30 minutes | 500 RPM | John Doe | No issues |
Annexure-2: Environmental Monitoring Log
| Date | Time | Temperature (°C) | Humidity (%) | Operator | Comments |
|---|---|---|---|---|---|
| 21/01/2026 | 09:00 AM | 22°C | 50% | Jane Smith | Conditions are stable |
Annexure-3: Deviation Report Form
| Deviation Description | Time | Batch Number | Operator | Immediate Action |
|---|---|---|---|---|
| Air incorporation during stirring | 10:00 AM | 12345 | John Doe | Adjusted stirring speed |
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 |