Standard Operating Procedure for Blending of Final Dried API in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/070/2025 |
| Supersedes | SOP/API/070/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define a standardized procedure for blending final dried API to ensure uniformity of the bulk material, proper homogeneity, and suitability for sampling and further processing.
2. Scope
This SOP is applicable to all blending operations performed on final dried APIs in the API manufacturing department using suitable equipment such as double cone blender, bin blender, or tumble mixer.
3. Responsibilities
- Production Operator: Carry out blending operation as per BMR instructions and record process parameters.
- Production Supervisor: Review blending operations, verify settings, and authorize batch progression.
- QA Department: Perform line clearance and approve final blended material for sampling.
4. Accountability
The Production Head is accountable for execution of the blending process. QA Head is responsible for reviewing blending records and authorizing batch release.
5. Procedure
5.1 Pre-Blending Checks
- Ensure that:
- Drying is completed and approved.
- All previous steps are documented in BMR.
- Blender is cleaned and labeled “Cleaned”.
- Perform line clearance and document it.
- Record blender ID, cleaned status, and previous usage history.
5.2 Equipment and Material Transfer
- Transfer dried API from containers to blender using SS scoops or vacuum transfer system.
- Use nitrogen blanketing if required for oxygen-sensitive materials.
- Load the entire batch to avoid partial blending unless otherwise specified in the process validation protocol.
5.3 Blending Parameters
- Set blending time and RPM as defined in the Master Batch Record (e.g., 20 minutes at 12 RPM).
- Start the blender and monitor operation for vibration, noise, or mechanical issues.
- Upon completion, allow the material to settle before unloading.
5.4 Sampling and Homogeneity Check
- Perform stratified sampling from top, middle, and bottom using sampling thief.
- Submit composite samples to QC for blend uniformity and particle size verification.
- Only proceed for packaging or transfer after QA/QC approval of blend.
5.5 Unloading and Documentation
- Unload blended API into clean, labeled SS containers or lined drums.
- Label each container with:
- Product Name
- Batch No.
- Blending Date
- Container No.
- Quantity
- Record all activities in “Blending Operation Log” (Annexure-1).
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- QC: Quality Control
- RPM: Revolutions Per Minute
7. Documents
- Blending Operation Log (Annexure-1)
- Batch Manufacturing Record
- Cleaning Checklist
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- US FDA 21 CFR Part 211
- Internal Equipment Validation Protocols
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 Operation Log
| Date | Batch No. | Blender ID | Start Time | End Time | RPM | Remarks |
|---|---|---|---|---|---|---|
| 13/04/2025 | API-BLEND-20250413 | DCB-02 | 10:00 | 10:20 | 12 | Uniform Blend |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | Blending Procedure Introduction | QA Head |
| 13/04/2025 | 2.0 | Included Uniform Sampling and Nitrogen Use | Process Optimization | QA Head |