SOP for Documentation of Calibration Activities – V 2.0

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