Standard Operating Procedure for Monitoring of Agitation Speed and RPM in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/094/2025 |
| Supersedes | SOP/ELX/094/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standardized procedure for monitoring and controlling agitation speed (RPM) during the manufacturing of elixir formulations to ensure proper mixing, homogeneity, and batch reproducibility.
2. Scope
This SOP applies to all mixing operations using mechanical stirrers or variable speed agitators in the Elixir Department during batch manufacturing.
3. Responsibilities
- Production Operator:
- Set and monitor agitation speed as per batch manufacturing record (BMR).
- Record start and end RPM values and any variations.
- Production Supervisor:
- Ensure that set RPM parameters are followed and verified during in-process checks.
- QA Officer:
- Audit agitation logs and confirm speed consistency with validated parameters.
4. Accountability
The Head of Production is accountable for ensuring that all agitation equipment is calibrated, RPM is correctly maintained, and documented in accordance with GMP requirements.
5. Procedure
5.1 Equipment Calibration and Verification
- Ensure the agitator RPM display is calibrated as per the annual calibration schedule.
- Verify the RPM reading at idle before starting the batch.
- Attach calibration label with due date visibly on the agitator panel.
5.2 Agitation Speed Setup
- Refer to the BMR or master formula to identify the required RPM range (e.g., 200–250 RPM).
- Set the desired RPM using the control panel on the agitator.
- Allow the agitator to run for 1–2 minutes to stabilize the speed before starting ingredient addition.
5.3 In-Process Monitoring
- Monitor RPM every 15–30 minutes or as specified in the BMR.
- Record the readings in the Agitation Monitoring Log (Annexure-1).
- Note any fluctuations above or below the specified range and notify the supervisor immediately.
5.4 Handling Deviations
- If deviation is less than ±5% of set RPM and stable, continue operation and record as minor deviation.
- If deviation is more than ±5% or fluctuates continuously, stop operation and escalate to engineering and QA.
- Document deviation details and corrective action in the Deviation Record.
5.5 Completion and Documentation
- Record final RPM at end of mixing and verify it matches with initial set value.
- Ensure the Agitation Monitoring Log is reviewed and signed by the supervisor.
- Attach the log to the BMR for QA review.
6. Abbreviations
- SOP: Standard Operating Procedure
- RPM: Revolutions Per Minute
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Agitation Monitoring Log (Annexure-1)
- Deviation Record (if applicable)
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.100 – Written Procedures; Deviations
- WHO TRS 986 – GMP for Pharmaceutical Products
- ICH Q8 – Pharmaceutical Development
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Agitation Monitoring Log
| Date | Batch No. | Start RPM | Mid-Process RPM | End RPM | Checked By | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1033 | 220 | 218 | 220 | Rajesh Kumar | Stable throughout |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added deviation thresholds and verification points | GMP Enhancement | QA Head |