Procedure for Documentation of Calibration Activities
| Department | Quality Assurance (QA)/Quality Control (QC)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/162 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for documenting calibration activities in pharmaceutical manufacturing. Proper documentation ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and equipment reliability for accurate measurements.
2. Scope
This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Engineering departments responsible for calibrating, maintaining, and documenting calibration records for all measuring instruments and equipment used in production, laboratory testing, and quality control processes.
3. Responsibilities
- Calibration Technician: Performs calibration and records results.
- Engineering Department: Ensures calibration schedules are maintained.
- QA Officer: Reviews calibration reports for compliance.
- QA Manager: Approves and ensures adherence to calibration procedures.
4. Accountability
The QA and Engineering Managers are accountable for ensuring that all calibration activities and documentation meet GMP, FDA, ICH, and WHO requirements.
5. Procedure
5.1 Types of Equipment Requiring Calibration
The following types of equipment must be included in the calibration program:
- Weighing Balances: Analytical and precision balances used in laboratories and production.
- pH Meters: Instruments used to measure acidity/alkalinity of solutions.
- Thermometers and Hygrometers: Devices used to monitor
environmental conditions.
Pressure Gauges: Instruments used to measure pressure in vessels and pipelines.
HPLC and GC Instruments: Analytical instruments used in QC testing.
UV-Visible Spectrophotometers: Used for absorbance and purity testing.
5.2 Calibration Schedule and Frequency
- Each instrument must have a **defined calibration schedule** based on manufacturer recommendations and regulatory requirements.
- Calibration frequency must be categorized as:
- Daily – e.g., analytical balances.
- Weekly – e.g., temperature monitoring probes.
- Monthly – e.g., pH meters.
- Quarterly – e.g., spectrophotometers.
- Annually – e.g., HPLC and GC instruments.
- The calibration schedule must be maintained in a **Calibration Master Log.**
5.3 Calibration Procedure
- The Calibration Technician must follow a **predefined calibration protocol.**
- Calibration activities must include:
- Instrument identification and serial number.
- Calibration standards used.
- Pre-calibration readings.
- Adjustment and corrective actions taken.
- Final calibration readings.
- All calibration data must be recorded in the **Calibration Log Sheet.**
5.4 Documentation and Record Keeping
- Calibration records must include:
- Equipment name and location.
- Calibration frequency.
- Calibration date and next due date.
- Calibration method and reference standards used.
- Results and pass/fail status.
- Technician signature and QA approval.
- Electronic records must be stored in a **validated document management system (DMS).**
5.5 Handling Out-of-Specification (OOS) Calibration Results
- If an instrument fails calibration, it must be **immediately taken out of service.**
- A **Deviation Report** must be initiated and sent to QA.
- Corrective actions may include:
- Instrument recalibration.
- Equipment maintenance or repair.
- Replacement of instrument components.
- Recalibration must be performed before the instrument is used again.
5.6 Review and Approval of Calibration Records
- QA must review calibration logs **monthly.**
- Calibration certificates must be stored with batch records if applicable.
- Records must be archived for **a minimum of 5 years.**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- DMS – Document Management System
- OOS – Out of Specification
- HPLC – High-Performance Liquid Chromatography
- GC – Gas Chromatography
7. Documents
- Calibration Master Log (Annexure-1)
- Calibration Log Sheet (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO Guidelines on Calibration
- US FDA Guidance on Equipment 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: Calibration Master Log
| Date | Instrument | Location | Calibration Due Date | Status | QA Approval |
|---|---|---|---|---|---|
| 02/02/2025 | HPLC System | QC Lab | 02/08/2025 | Pass | Approved |
Annexure-2: Calibration Log Sheet
| Date | Instrument | Calibration Standard | Pre-Calibration Reading | Final Reading | Technician | QA Approval |
|---|---|---|---|---|---|---|
| 02/02/2025 | Analytical Balance | Weight Set | ±0.02g | ±0.01g | John Doe | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Calibration Documentation | Improved Compliance | QA Head |