Procedure for Final Mixing Stage in Ointment Manufacturing
| Department | Production/Quality Assurance (QA)/Research and Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/034 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized process for the final mixing stage in ointment manufacturing. This stage ensures homogeneity, proper dispersion of active ingredients, and overall product consistency.
2. Scope
This SOP applies to all personnel involved in the final mixing stage of ointment production in the manufacturing area.
3. Responsibilities
- Production Supervisor: Ensures adherence to the final mixing parameters.
- Machine Operator: Controls mixing speed, temperature, and duration.
- Quality Assurance (QA) Personnel: Verifies homogeneity and compliance with GMP standards.
- R&D Scientist: Provides formulation specifications and process validation.
4. Accountability
The Production and QA Managers are accountable for ensuring that the final mixing stage is conducted as per GMP standards and properly documented.
5. Procedure
5.1 Pre-Mixing Preparations
- Ensure that the cooling process has been completed.
- Verify the equipment’s cleanliness and calibration status.
- Check that the batch meets the required temperature for final mixing (e.g., 35°C-45°C).
5.2 Initiation of Final Mixing
- Start the mixer at a slow speed to avoid air entrapment.
- Gradually increase the mixing speed to ensure uniform dispersion.
- Maintain the required
mixing time as per the Batch Manufacturing Record (BMR).
5.3 Monitoring During Mixing
- Check for uniformity in texture and viscosity.
- Ensure no air bubbles are trapped in the ointment.
- Monitor temperature and adjust mixing parameters if needed.
5.4 Completion of Mixing
- Reduce mixing speed gradually to prevent phase separation.
- Confirm complete homogenization and uniform distribution of active ingredients.
- Conduct an in-process quality check before batch approval.
5.5 Documentation and Approval
- Record all process parameters in the Final Mixing Log.
- QA must verify and approve the batch before transferring for filling.
- Label the batch as “Final Mixed and Ready for Filling.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Final Mixing Log (Annexure-1)
- In-Process Quality Check Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- Equipment Manufacturer Guidelines
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Final Mixing Log
| Date | Batch Number | Mixing Speed (RPM) | Temperature (°C) | Mixing Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | 500 | 40°C | 20 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | 600 | 38°C | 25 | QA Officer |
Annexure-2: In-Process Quality Check Report
| Date | Batch Number | Test Parameter | Specification | Result | Final Status |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Viscosity | 1000-2000 cP | 1500 cP | Pass |
| 02/02/2025 | SOP/Ointment/002 | pH | 5.5-7.0 | 6.2 | Pass |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |