Standard Operating Procedure for Maintenance of Column Usage Logs in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/138/2025 |
| Supersedes | SOP/API/138/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a consistent and traceable system for documenting the usage of chromatographic columns used in HPLC analysis to monitor column life, detect performance trends, and ensure reliability of analytical data.
2. Scope
This SOP applies to all analytical columns used in HPLC systems for the analysis of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs) in the
Quality Control (QC) laboratory.
3. Responsibilities
- QC Analyst: Record column usage details in the usage logbook after every analysis.
- QC Reviewer: Verify proper logging and monitor performance deterioration.
- QC Supervisor: Approve column usage beyond its standard lifecycle based on performance data.
4. Accountability
The Head – Quality Control is accountable for ensuring column usage is monitored, recorded, and evaluated in accordance with this SOP and applicable regulatory requirements.
5. Procedure
5.1 Column Identification and Registration
- Upon receipt, assign a unique ID number to each column (e.g., C-001/2025).
- Label the column with its unique ID and record it in the Column Master Register with details such as:
- Column make and model
- Stationary phase and dimensions
- Serial number
- Date of receipt
- Expiry date (if applicable)
5.2 Column Usage Log Maintenance
- Maintain a Column Usage Logbook (Annexure-1) for each column to record:
- Usage date
- Test performed
- Sample/batch number
- Flow rate, temperature, injection volume
- No. of injections
- Observations (e.g., peak shape, pressure)
- Update the cumulative number of injections with each use.
5.3 Column Performance Monitoring
- Review chromatographic parameters such as:
- Theoretical plates
- Retention time consistency
- Peak tailing
- System pressure trends
- If abnormal performance is noted, document the deviation and consult QC Supervisor.
- Retire the column when performance fails to meet system suitability criteria.
5.4 Column Cleaning and Storage
- After use, flush the column with appropriate solvent as per manufacturer’s instructions.
- Store the column capped, filled with storage solvent, and labeled with the last date of use.
- Record column flushing and storage in the usage logbook.
5.5 Column Disposal
- Dispose of the column when it exceeds lifecycle or shows irreversible performance decline.
- Document disposal in the Column Retirement Log (Annexure-2).
- Remove the column from active inventory.
6. Abbreviations
- HPLC: High Performance Liquid Chromatography
- QC: Quality Control
- ID: Identification
- SOP: Standard Operating Procedure
7. Documents
- Column Master Register
- Column Usage Logbook (Annexure-1)
- Column Retirement Log (Annexure-2)
- Calibration Records
8. References
- ICH Q2(R1) – Validation of Analytical Procedures
- 21 CFR Part 211
- Manufacturer’s Instructions for Use
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Column Usage Logbook
| Date | Column ID | Batch No. | Test | No. of Injections | Observation | Analyst |
|---|---|---|---|---|---|---|
| 13/04/2025 | C-001/2025 | API-20250413 | Assay | 6 | Normal | Sunita Reddy |
Annexure-2: Column Retirement Log
| Date | Column ID | Reason for Retirement | Total Injections | Disposed By | Verified By |
|---|---|---|---|---|---|
| 13/04/2025 | C-002/2024 | Failing system suitability | 550 | Ravi Kumar | QA Officer |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | Regulatory Compliance | QA Head |
| 13/04/2025 | 2.0 | Added Annexures and Performance Criteria | Audit Observation | QA Head |