OBJECTIVE:

• The objective of this SOP is to define the procedure for internal calibration, external calibration, finalization of calibration frequency, and preparation calibration plans for equipment, instruments, and monitoring devices used in pharmaceutical operations.

SCOPE:

• This SOP applies to all GMP-critical and non-critical equipment, instruments, and monitoring devices installed and used in Production, Quality Control, Quality Assurance, Engineering, Warehouse, and Utilities areas at the manufacturing facility.
• This SOP covers internal calibration, external calibration, frequency determination, out-of-tolerance handling, and calibration documentation.

RESPONSIBILITIES:

Engineering Department:

• Shall prepare and maintain the calibration master list.
• Shall perform internal calibration as per approved procedures.
• Shall coordinate with external calibration agencies where applicable.
• Shall ensure timely completion of calibration activities.

Quality Assurance (QA):

• Shall approve calibration procedures, frequency, and plans.
• Shall review calibration records and certificates.
• Shall assess impact and initiate deviation/CAPA for out-of-tolerance results.

User Department:

• Shall ensure equipment is made available for calibration.
• Shall not use equipment that is overdue or failed calibration.

External Calibration Agency:

• Shall perform calibration using traceable reference standards.
• Shall provide valid calibration certificates with traceability details.

DEFINATIONS:

• Calibration: A documented process of comparing a measuring instrument against a traceable reference standard to ensure accuracy.
• Internal Calibration: Calibration performed in-house using qualified reference standards.
•  External Calibration: Calibration performed by an approved, competent external agency.

PROCEDURE:

General Requirements:

• All instruments shall be uniquely identified with a calibration ID number.
• Calibration status labels shall be affixed indicating calibrated date, due date, and status.
• Equipment shall not be used if calibration is overdue, failed, or status is unclear.

Calibration Classification:

• Calibration shall be classified as:
  • • Internal Calibration
    • External Calibration
• The calibration schedule shall be defined in the Validation Master Plan (VMP).

Internal Calibration Procedure:

• Internal calibration shall be performed by trained and authorized User Department / Engineering personnel.
• Calibrations shall be performed using approved and traceable procedure.
• Calibration steps, acceptance criteria, and results shall be documented in the Calibration Record.
• Calibration results shall be reviewed and verified by User Department / Engineering.

External Calibration Procedure:

• External calibration shall be performed by Qualified Service provider / Agencies.
• Qualified Service Provider Agencies shall comply with our requirements as per Regulatory compliance and they should be having credentials needs for the particular task.
• Calibration certificates shall include:
  • Instrument identification
  • Calibration date and due date
  • Reference standards used
  • Traceability to national/international standards
  • Acceptance criteria and results
• Engineering shall review and approve calibration certificates before closure.

Criteria for Finalization of Calibration Frequency:

• Calibration frequency shall be determined based on:
  • • Criticality of equipment/instrument
    • Manufacturer’s recommendation
    • Frequency of use
    • Historical calibration data
    • Impact on product quality

Calibration Frequencies:

• Final frequency shall be assessed on the criteria above and Final frequency shall be approved by QA.

Finalization of Calibration Plan:

• A Yearly Calibration Plan shall be prepared before the start of each calendar year.
• Where applicable, Six-monthly and Quarterly Plans shall be derived from the yearly plan.
• The plan shall include instrument ID, location, frequency, and calibration type.
• QA shall approve the calibration plan prior to implementation.

Handling of Out-of-Tolerance (OOT) Results:

• Any OOT result shall be immediately reported to QA.
• Impact assessment on previously released products shall be performed.
• An Incident / deviation shall be raised and CAPA shall be implemented where required.
• Equipment shall not be used until recalibration and QA clearance.

Calibration Status Control:

• Status labels shall be maintained on each calibrated item.
• Electronic or manual tracking shall be maintained to prevent overdue calibration.
• All calibration-related documents shall be retained for five (5) years.
• Calibration activities shall be planned and executed within the defined calibration frequency.
• A grace period of ±30 days shall be permitted for instruments having yearly calibration frequency, provided that:
  • The instrument remains within calibration validity
  • No critical process is adversely affected
  • No previous out-of-tolerance trend exists
• If calibration is not performed within the allowed tolerance period, the instrument shall be considered overdue, and an incident / deviation shall be initiated.
• The instrument shall not be used for GMP activities until calibration is completed and QA clearance is obtained.
• Performing calibration earlier than the due date within the allowed tolerance shall not require deviation and shall not alter the predefined calibration frequency.

REFERENCE:

• WHO TRS 986, Annex 2 – WHO GMP and WHO TRS 961 – Qualification and Validation
• Equipment Manufacturer Manuals

 RECORDS:

 REVISION HISTORY: