Standard Operating Procedure for Identification and Traceability of Manufacturing Tanks
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/084/2025 |
| Supersedes | SOP/ELX/084/2022 |
| 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 consistent and traceable system for identification and labeling of manufacturing tanks used in elixir processing to ensure proper documentation, operational control, and compliance with cGMP requirements.
2. Scope
This SOP applies to all fixed and mobile stainless steel manufacturing tanks used for mixing, storage, and transfer of elixirs in the Elixir Department.
3. Responsibilities
- Production Operator:
- Ensure tanks are properly labeled with unique identification and product-specific status tags.
- Production Supervisor:
- Verify tank identity before use and ensure accurate batch-related traceability.
- QA Officer:
- Audit tank traceability records and ensure label integrity throughout operations.
4. Accountability
The Head of Production is accountable for ensuring that all manufacturing tanks are uniquely identified and traceable to their respective batches and operations.
5. Procedure
5.1 Tank Identification System
- Assign a unique Tank
ID to each vessel using the following format:
Affix durable, clearly legible stainless steel or laminated label to each tank showing:
Maintain Tank Master List (Annexure-1) for all assigned IDs.
- Format: ELX-MT-XXX (e.g., ELX-MT-001)
- Tank ID
- Capacity
- Designated Use (e.g., Mixing, Storage)
5.2 Batch-Specific Labeling
- Prior to starting any batch, affix a removable status label to the tank indicating:
- Product Name
- Batch Number
- Stage (e.g., Under Mixing, Under Storage, Cleaned)
- Date and Time
- Labels must be updated immediately upon stage change.
- Use color-coded tags where applicable for enhanced visibility.
5.3 Traceability Records
- Record all usage of tanks in the Tank Utilization Log (Annexure-2).
- Entries must include:
- Date
- Tank ID
- Product Name
- Batch Number
- Operation Performed
- Operator Initials
- Attach log copies to respective BMRs after batch completion.
5.4 Inspection and Maintenance of Labels
- Inspect identification plates monthly for readability and damage.
- Replace damaged or faded labels immediately and update Tank Master List accordingly.
- Only QA-approved label templates shall be used.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- ID: Identification
7. Documents
- Tank Master List (Annexure-1)
- Tank Utilization Log (Annexure-2)
- Status Label Template (Annexure-3)
8. References
- 21 CFR Part 211.105 – Equipment Identification
- WHO TRS 1019 – GMP for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Tank Master List
| Tank ID | Capacity (Litres) | Designation | Location | Remarks |
|---|---|---|---|---|
| ELX-MT-001 | 500 | Mixing | Elixir Room 1 | In Use |
| ELX-MT-002 | 750 | Storage | Elixir Room 2 | Cleaned |
Annexure-2: Tank Utilization Log
| Date | Tank ID | Batch No. | Operation | Operator | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-MT-001 | ELX-1023 | Mixing | Rajesh Kumar | Completed |
Annexure-3: Status Label Template
| Product Name | Batch No. | Status | Tank ID | Date | Operator |
|---|---|---|---|---|---|
| Paracetamol Elixir | ELX-1023 | UNDER MIXING | ELX-MT-001 | 11/04/2025 | Rajesh Kumar |
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 Status Label Template and Traceability Enhancements | Audit Recommendation | QA Head |