Standard Operating Procedure (SOP)

Here’s a comprehensive Standard Operating Procedure (SOP) for the Calibration of Instruments in Production and Quality Control departments in a pharmaceutical or regulated manufacturing environment.

1. Purpose

To establish a uniform procedure for the calibration of instruments and equipment used in Production and Quality Control departments to ensure accuracy, precision, and compliance with regulatory requirements.

2. Scope

This SOP applies to all instruments and measuring devices used in the Production and Quality Control departments that require calibration, such as balances, pH meters, thermometers, pressure gauges, HPLC, UV spectrophotometers, etc.

3. Responsibility

• Production/QC Staff: Ensure instruments are sent for calibration as per the schedule and verify post-calibration status.

• QA Department: Approve calibration status and ensure compliance with SOP.

• Engineering/Calibration Team: Perform calibration and maintain records.

4. Definitions

• Calibration: The process of configuring an instrument to provide a result within an acceptable range by comparing it with a known standard.

• Due Date: The date by which calibration must be completed.

• Calibration Status Label: A tag showing the last calibration date, due date, and instrument ID.

5. Materials and Equipment Required

• Calibration standards (traceable to national/international standards)

• Calibration logbook/register

• Standard operating procedures for each instrument

• Certificates of calibration (from in-house or external certified agencies)

• Personal Protective Equipment (PPE)

6. Procedure

6.1 Calibration Schedule

• Maintain a Master Calibration Schedule listing all instruments, their calibration frequency, and due dates.

• Review the schedule monthly and ensure timely calibration.

6.2 Calibration Execution

1. Preparation:

   • Check the instrument’s current calibration status.

   • Ensure the instrument is clean and functioning.

   • Use calibrated reference standards traceable to certified national/international standards.

2. Calibration Process:

   • Perform calibration according to the instrument-specific SOP or manufacturer guidelines.

   • Record actual readings and deviations, if any.

   • If within tolerance limits, label the instrument as “Calibrated.”

3. Post-Calibration:

   • Attach a calibration status label on the instrument with:

     • Instrument ID

     • Date of calibration

     • Due date

     • Calibrated by (initials/signature)

4. Out-of-Tolerance Instruments:

   • If the instrument fails calibration:

     • Mark it as “OUT OF CALIBRATION – DO NOT USE.”

     • Notify the department head and QA.

     • Investigate and assess any potential impact on previous results.

6.3 Documentation

• Record calibration results in the Calibration Record Sheet.

• Update the Calibration Logbook/Register.

• File the Calibration Certificate (internal or external).

• QA to review and archive calibration documents.

7. Handling of Instruments with Missed Calibration

• Immediately quarantine any instrument with missed calibration.

• Perform calibration and evaluate any data generated since the last valid calibration.

• Record the incident and investigate for any impact.

8. Precautions

• Never use an instrument with an expired calibration.

• Ensure calibration is performed in an appropriate environment (temperature, humidity).

• Use gloves and antistatic tools where necessary.

• Handle reference standards carefully to avoid damage.

9. Abbreviations

• SOP – Standard Operating Procedure

• QA – Quality Assurance

• QC – Quality Control

• HPLC – High-Performance Liquid Chromatography

• UV – Ultraviolet

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