Standard Operating Procedure for Calibration of Analytical Instruments in QC Labs
| Department | Quality Control |
|---|---|
| SOP No. | SOP/TAB/119/2025 |
| Supersedes | SOP/TAB/119/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for the calibration of analytical instruments used in Quality Control (QC) laboratories, ensuring that all equipment operates accurately and meets regulatory standards.
2. Scope
This SOP applies to all analytical instruments used in QC labs for tablet analysis, including but not limited to HPLC, UV-Vis spectrophotometers, pH meters, and balances. Calibration must be performed regularly to maintain accuracy and compliance with internal and regulatory standards.
3. Responsibilities
- Quality Control (QC): Responsible for ensuring all analytical instruments are calibrated according to this SOP and maintaining calibration records.
- Quality Assurance (QA): Ensures that the calibration process complies with internal and regulatory standards and reviews calibration records.
- Laboratory Personnel: Responsible for performing the calibration according to the specified procedure and maintaining accurate documentation of the process.
4. Accountability
The QC Manager is accountable for ensuring that all analytical instruments in the QC lab are calibrated as per the established schedule. The QA
Manager is responsible for reviewing and approving calibration records to ensure compliance with regulatory requirements.
5. Procedure
5.1 Instrument Selection and Preparation
- Select the analytical instrument to be calibrated based on the testing schedule.
- Ensure that the instrument is clean and in proper working condition before calibration.
- Prepare any necessary calibration standards and solutions according to the instrument’s specifications.
5.2 Calibration Procedure
- For HPLC:
- Inject the calibration standard solution with a known concentration into the HPLC system.
- Record the retention time and peak areas.
- Compare the results with the known values and adjust the system if necessary to achieve accurate readings.
- For UV-Vis Spectrophotometers:
- Prepare calibration standards with known absorbance values across the range of wavelengths to be tested.
- Measure the absorbance of the calibration standards at predetermined wavelengths.
- Compare the measured absorbance with the expected values to ensure the accuracy of the spectrophotometer.
- For pH Meters:
- Calibrate the pH meter using at least two buffer solutions that bracket the expected pH range of the sample.
- Check the meter’s response and ensure it provides accurate readings according to the buffer solutions used.
- For Balances:
- Perform calibration by using certified calibration weights.
- Verify that the balance reads accurately across the required weight range, typically from 1 mg to the balance’s maximum capacity.
5.3 Frequency of Calibration
- Calibration should be performed at regular intervals, typically monthly or quarterly, depending on the manufacturer’s recommendation or regulatory requirements.
- Instruments should also be calibrated whenever there is a significant change in environmental conditions or after maintenance or repair.
5.4 Documentation and Record-Keeping
- Record the calibration results, including the instrument identification, calibration date, calibration standard used, and the person performing the calibration.
- Maintain calibration certificates and logs in a secure location for future audits and inspections.
- Ensure that calibration records are reviewed by QA to confirm compliance with the relevant standards and procedures.
5.5 Calibration Deviation Handling
- If an instrument fails calibration, take immediate corrective actions. This may include recalibration, maintenance, or repair of the instrument.
- Document any deviations, corrective actions, and re-tests in the deviation report (Annexure-1).
- Ensure that the instrument is re-checked and recalibrated before being used for further analysis.
5.6 Post-Calibration Actions
- Ensure that all equipment is returned to service after calibration and that the calibration stickers or labels are updated with the next due calibration date.
- Dispose of any waste generated during the calibration process in accordance with the company’s waste disposal policies.
- Ensure that all necessary adjustments to the equipment are made after calibration, and the instrument is verified for proper functioning before use.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- HPLC: High-Performance Liquid Chromatography
- UV-Vis: Ultraviolet-Visible Spectroscopy
- pH: Potential of Hydrogen
7. Documents
- Calibration Log (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <1058> – Analytical Instrument Qualification
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Specifications for Analytical Instrument Calibration
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Report
| Deviation Date | Instrument ID | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | HPLC-01 | Calibration failure due to improper standard | Re-calibrated with a fresh standard | John Doe |
Annexure-2: Calibration Log
| Instrument ID | Calibration Date | Standard Used | Calibrated By | Next Calibration Due |
|---|---|---|---|---|
| HPLC-01 | 01/01/2026 | HPLC Standard Solution | Jane Smith | 01/01/2027 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Added instrument-specific calibration methods | Improved calibration accuracy | QA Head |