Elixir Department: SOP for Calibration of Dispensing Balances – V 2.0

Posted on By

Elixir Department: SOP for Calibration of Dispensing Balances – V 2.0

Standard Operating Procedure for Calibration of Balances Used in Material Dispensing

Department Elixir Department
SOP No. SOP/ELX/033/2025
Supersedes SOP/ELX/033/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define a systematic procedure for the calibration of balances used during the dispensing of raw materials and excipients in the Elixir Department. This ensures weighing accuracy, minimizes errors, and maintains compliance with GMP.

2. Scope

This SOP applies to all analytical, precision, and top-loading balances used in the dispensing areas (including laminar airflow cabinets and weighing rooms) of the Elixir Department.

3. Responsibilities

  • Dispensing Operator:
    • Perform daily calibration checks before start of operation.
    • Record calibration data and report deviations if any.
  • Engineering Department:
    • Conduct periodic preventive maintenance and external calibration.
  • QA Department:
    • Verify calibration logs and approve equipment for use.

4. Accountability

The Head of the Elixir Department is accountable for ensuring that all balances are calibrated, documented, and maintained in a validated state as per GMP.

See also  Elixir Department: SOP for Verification of Raw Materials Before Dispensing - V 2.0

5. Procedure

5.1 Types

of Calibration
  1. Daily Calibration: Performed by the operator using certified standard weights.
  2. Monthly Internal Calibration: Conducted by the Engineering team.
  3. Annual External Calibration: Performed by an external authorized calibration agency.

5.2 Daily Calibration Procedure

  1. Switch on the balance and allow it to warm up for at least 30 minutes.
  2. Ensure the balance is clean, levelled, and placed on a vibration-free surface.
  3. Use calibrated standard weights (Class F2 or better) with valid calibration certificates.
  4. Perform calibration at two points:
    • Low range (e.g., 10 g)
    • High range (e.g., 500 g or 1000 g depending on balance capacity)
  5. Record the observed reading and compare it against the standard weight. Acceptable tolerance: ±0.1% or as specified in the balance SOP.
  6. If reading is outside the tolerance limit, report immediately to the Engineering Department and QA.

5.3 Monthly and Annual Calibration

  1. Engineering shall perform internal calibration checks and adjust balance if deviation is observed.
  2. Annual calibration must be done by a NABL-accredited agency and traceable to national standards.
  3. Calibration certificates must be filed and referenced in the equipment qualification record.

5.4 Labeling and Equipment Status

  1. All balances must have a calibration status label affixed indicating:
    • Equipment ID
    • Last Calibration Date
    • Next Calibration Due Date
    • Engineer Initials
  2. Balances without valid calibration label must not be used and should be tagged “Under Maintenance.”

5.5 Documentation and Deviation Management

  1. Enter daily calibration results in the Balance Calibration Log (Annexure-1).
  2. Attach calibration certificates in the Equipment Qualification File.
  3. Report any deviation or failure to QA using a deviation report form. QA will investigate and approve further action.

6. Abbreviations

  • QA: Quality Assurance
  • SOP: Standard Operating Procedure
  • NABL: National Accreditation Board for Testing and Calibration Laboratories
  • GMP: Good Manufacturing Practice

7. Documents

  1. Balance Calibration Log (Annexure-1)
  2. Calibration Certificate (Annexure-2)
  3. Deviation Report Form (Annexure-3)

8. References

  • ICH Q7: GMP for Active Pharmaceutical Ingredients
  • 21 CFR Part 211 – Current Good Manufacturing Practice
  • IS/ISO/IEC 17025 – Calibration and Testing Laboratories

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Balance Calibration Log

Date Balance ID Weight Used (g) Observed Value (g) Deviation (%) Operator
11/04/2025 BLX-01 500.00 499.85 0.03% Rajesh Kumar

Annexure-2: Calibration Certificate

Balance ID Calibrated By Date Valid Till Certificate No.
BLX-01 Precision Cal Lab 01/01/2025 31/12/2025 PCL/025/2025

Annexure-3: Deviation Report Form

Date Equipment ID Observed Issue Reported By Action Taken QA Approval
10/04/2025 BLX-02 Weight deviation > 0.5% Sunita Reddy Sent for recalibration Approved by QA

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New Implementation QA Head
11/04/2025 2.0 Revised Format, Added External Calibration Guidelines Standardization & Compliance QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,