Standard Operating Procedure for Preparation of Manufacturing Tank for Elixir Production
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/051/2025 |
| Supersedes | SOP/ELX/051/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define a systematic procedure for the preparation and verification of the manufacturing tank prior to elixir production, ensuring it is clean, functional, and compliant with GMP standards.
2. Scope
This SOP applies to all personnel involved in the preparation and use of manufacturing tanks in the Elixir Department for the production of liquid oral dosage forms.
3. Responsibilities
- Manufacturing Operator: Clean, inspect, and prepare the tank as per this SOP.
- Production Supervisor: Verify and authorize the tank readiness before batch processing.
- QA Officer: Audit and approve the line clearance and ensure all documentation is complete.
4. Accountability
The Production Head is accountable for ensuring all manufacturing tanks are prepared according to this SOP before use in batch manufacturing.
5. Procedure
5.1 Equipment Identification
- Verify the tank ID tag
and batch allocation sheet to ensure the correct tank is being used.
Record the tank number in the BMR and Line Clearance Record (Annexure-1).
5.2 Cleaning Confirmation
- Ensure the tank has been cleaned as per SOP for equipment cleaning and CIP (if applicable).
- Check for absence of water, cleaning agents, or previous product residues inside the tank.
- Verify status label is “CLEANED” with cleaning date and time. If not, send the tank for re-cleaning.
5.3 Visual and Functional Checks
- Check internal and external tank surface for cleanliness, rust, or dents.
- Inspect lid, manhole, and outlet valves for proper sealing and smooth operation.
- Check agitator shaft for freedom of movement.
- Ensure that the volume graduation markings are intact and legible.
5.4 Assembly Verification
- Ensure all detachable parts (gaskets, spray balls, valves) are assembled properly.
- Tighten clamps, bolts, and connections before use.
5.5 Line Clearance
- Initiate line clearance procedure and fill the Line Clearance Checklist (Annexure-1).
- Remove any unused labels, materials, or documentation from the surrounding area.
- Obtain QA clearance before starting batch processing.
5.6 Documentation
- Record the tank readiness in the Equipment Preparation Log (Annexure-2).
- Attach the Line Clearance approval page to the BMR.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- CIP: Clean-in-Place
- SOP: Standard Operating Procedure
7. Documents
- Line Clearance Checklist (Annexure-1)
- Equipment Preparation Log (Annexure-2)
- Tank Status Tag Record (Annexure-3)
8. References
- WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
- 21 CFR Part 211 – Current GMPs for Finished Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Line Clearance Checklist
| Item | Status (Yes/No) | Checked By |
|---|---|---|
| Tank Cleaned Label Present | Yes | Sunita Reddy |
| Tank Dry and Free of Residue | Yes | Sunita Reddy |
| Area Free from Previous Batch Materials | Yes | Sunita Reddy |
Annexure-2: Equipment Preparation Log
| Date | Tank ID | Status | Checked By |
|---|---|---|---|
| 11/04/2025 | TANK-ELX-04 | Ready | Rajesh Kumar |
Annexure-3: Tank Status Tag Record
| Tank ID | Status | Last Cleaning Date | Next Due | Verified By |
|---|---|---|---|---|
| TANK-ELX-04 | Cleaned | 10/04/2025 | 20/04/2025 | Manju Sharma |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Issue | New SOP | QA Head |
| 11/04/2025 | 2.0 | Updated with Annexures and Line Clearance Process | GMP Alignment | QA Head |