Standard Operating Procedure (SOP)

Here is a detailed Standard Operating Procedure (SOP) for Calibration of Instruments in Production and Quality Control:

1. Purpose

To define the procedure for calibration of instruments and equipment used in production and quality control to ensure accuracy, precision, and compliance with regulatory standards.

2. Scope

This SOP is applicable to all measuring, monitoring, and testing instruments used in the Production and Quality Control departments of [Company Name], including balances, pH meters, spectrophotometers, thermometers, pressure gauges, etc.

3. Responsibilities

4. Definitions

• Calibration: Comparison of an instrument’s readings with a standard of known accuracy.

• Standard: A reference material or equipment traceable to national/international standards.

• Due Date: The next scheduled calibration date.

• Out of Calibration (OOC): When instrument readings deviate beyond the accepted tolerance.

5. Materials and Equipment Required

• Certified reference standards (traceable to national/international bodies)

• Calibration certificates of standards

• Calibration SOPs for individual instruments

• Calibration logbook/register

• Personal protective equipment (PPE)

• Labels or tags for calibration status

6. Procedure

6.1 Calibration Planning

1. Maintain a calibration master list of all instruments with the following:

   • Instrument ID

   • Location

   • Calibration frequency

   • Last calibration date

   • Next due date

2. Ensure all equipment is calibrated as per schedule or before use if not frequently used.

6.2 Calibration Execution

1. Perform calibration using traceable standards and following specific instrument SOPs.

2. Document all readings and determine if the instrument is within tolerance limits.

3. If within limits, mark the instrument as “CALIBRATED” with a tag showing:

   • Calibration date

   • Due date

   • Initials of the calibrator

4. If not within limits:

   • Mark as “OUT OF CALIBRATION”

   • Remove from service immediately

   • Report to supervisor/QA for corrective action

6.3 Post-Calibration

• Record calibration data in the calibration logbook/register.

• Archive certificates and data sheets in a designated folder.

• Ensure backup of calibration data in the electronic system if used.

6.4 Recalibration Intervals

• Based on:

  • Manufacturer’s recommendations

  • Regulatory requirements

  • Past calibration history

  • Criticality of the instrument

7. Handling of Out-of-Calibration Instruments

• Investigate and document the root cause.

• Review impact on past testing/production results.

• Recalibrate, repair, or replace the instrument before re-use.

8. Documentation

Maintain the following records:

• Calibration Master List

• Individual Instrument Calibration Reports

• Calibration Certificates

• Out-of-Calibration Reports

• Corrective Action Reports (if applicable)

9. Precautions

• Always use certified and valid standards.

• Ensure instruments are clean and operational before calibration.

• Perform calibration under controlled environmental conditions (as applicable).

10. References

• ISO 17025: General requirements for the competence of testing and calibration laboratories

• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients

• Equipment manuals and calibration SOPs

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