Standard Operating Procedure for End-Point Detection during Cream Mixing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/075/2025 |
| Supersedes | SOP/CRM/075/2022 |
| 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 defines the procedure for end-point detection during the mixing process of cream formulations. The goal is to identify when the cream mixture has reached the desired consistency, texture, and homogeneity, ensuring that it meets quality standards before moving to the next production phase.
2. Scope
This SOP applies to the cream mixing process in the Creams Department, covering all stages of mixing and the detection of the end-point for different types of cream formulations.
3. Responsibilities
- Production Team: Responsible for carrying out the mixing process, monitoring parameters, and detecting the end-point based on sensory and instrument-based indicators.
- Quality Control (QC): Responsible for verifying the quality of the mixture and ensuring that it meets the desired characteristics at the end-point stage.
- Quality Assurance (QA): Ensures compliance with GMP standards and reviews the mixing and end-point detection records.
4. Accountability
The Head of Production is accountable for ensuring that the mixing process is conducted according to this SOP and that the end-point is correctly detected. The QA Manager is responsible for reviewing and ensuring the process complies with regulatory and quality standards.
5. Procedure
5.1 Pre-Mixing Preparation
- Ensure that all ingredients for the cream formulation are pre-weighed, prepared, and ready for mixing.
- Verify that the mixing vessel is clean and properly prepared for use.
- Check that all mixing equipment (e.g., mixers, paddles, and sensors) are calibrated and functioning correctly.
5.2 Mixing Process
- Transfer the ingredients into the mixing vessel in the correct order, following the formulation’s requirements.
- Start the mixing process at a low speed to combine the ingredients and gradually increase the speed as the mixture becomes more uniform.
- Ensure that the mixing process is controlled to prevent the incorporation of air and achieve the desired consistency.
5.3 End-Point Detection
- During the mixing process, monitor key indicators for the end-point, including viscosity, consistency, and texture.
- Use a rheometer or viscometer to measure the cream’s viscosity. The end-point is reached when the viscosity readings stabilize within the required range.
- Alternatively, perform sensory checks by testing the texture and spreadability of the cream. The end-point is confirmed when the cream is smooth, with no lumps, and exhibits the correct consistency.
- Perform a sample test by taking a small quantity of the mixture and allowing it to cool to check for uniformity in texture.
5.4 Post Mixing Checks
- Once the end-point is detected, stop the mixing process to prevent over-processing or degradation of the product.
- Conduct a visual and tactile inspection of the cream to ensure it meets the required consistency and texture standards.
- Document the end-point detection results in the Mixing Log (Annexure-1), noting the time, temperature, and readings taken during the process.
5.5 Documentation
- Complete all relevant documentation, including batch numbers, mixing parameters (time, speed, temperature), and end-point test results in the Mixing Log (Annexure-1).
- Ensure that all records are reviewed and signed by the operator and the QA team to confirm compliance with the SOP.
5.6 Final Approval
- The QA team must review the mixing and end-point detection records and confirm that the cream batch has met the quality specifications before it moves to the next phase (e.g., transfer to storage or packaging).
- If the cream batch does not meet the required end-point characteristics, the process should be flagged for corrective action.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- R&D: Research and Development
7. Documents
- Annexure-1: Mixing Log
- Annexure-2: Sensory Testing Log
- Annexure-3: End-Point Detection Report
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: Mixing Log
| Batch Number | Mixing Time | Mixing Speed | End-Point Detected (Yes/No) | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | 30 minutes | 200 RPM | Yes | John Doe | No issues |
Annexure-2: Sensory Testing Log
| Batch Number | Texture | Spreadability | Color | Fragrance | Test Result |
|---|---|---|---|---|---|
| 12345 | Smooth | Good | White | Lavender | Pass |
Annexure-3: End-Point Detection Report
| Batch Number | End-Point Detected (Yes/No) | Final Viscosity | Final Texture | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | Yes | 1000 cP | Smooth | Jane Smith | End-point achieved successfully |
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 |