Standard Operating Procedure for Calibration of Weighing Balances Used in Elixir Dispensing

Department	Elixir Department
SOP No.	SOP/ELX/020/2025
Supersedes	SOP/ELX/020/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To establish a standardized procedure for calibration of weighing balances used in the dispensing area of the Elixir Department to ensure consistent weighing accuracy and compliance with GMP, WHO, and ICH guidelines.

2. Scope

This SOP applies to all analytical and precision balances located within the elixir raw material dispensing area that are used for weighing APIs, excipients, solvents, or other materials in elixir manufacturing.

3. Responsibilities

• Dispensing Operator:
  • Perform daily internal calibration before use.
  • Ensure no material is weighed on an uncalibrated balance.
• Engineering/Maintenance:
  • Conduct scheduled external calibration using standard certified weights.
• QA Officer:
  • Verify calibration status and records before batch initiation.

4. Accountability

The Head of QA and Head of Engineering are accountable for ensuring that all balances are calibrated, maintained, and used within specified tolerances.

5. Procedure

5.1 Types of Calibration

1. Internal Calibration: Performed by the user before each batch or once daily using built-in calibration mechanisms or standard weights.
2. External Calibration: Performed by Engineering or a qualified third-party agency as per schedule (monthly/quarterly) using traceable certified standard weights.

5.2 Daily Internal Calibration Procedure

1. Switch on the balance and allow stabilization for 30 minutes.
2. Clean the weighing pan and surroundings using a dry lint-free cloth.
3. Press the ‘Cal’ or ‘Internal Calibration’ button (as per equipment).
4. Wait until the balance displays “Calibration Complete.”
5. Record the calibration in the Daily Calibration Log (Annexure-1).

5.3 External Calibration Procedure

1. Clean the balance thoroughly and ensure it is levelled correctly using the built-in bubble level indicator.
2. Use certified calibration weights traceable to national standards.
3. Calibrate using at least three standard points:
   • Low point: e.g., 10 g
   • Midpoint: e.g., 100 g
   • High point: e.g., 500 g or full range
4. Record the observed reading vs. standard weight and calculate deviation.
5. Acceptable tolerance: ±0.1% of the standard weight used.
6. Affix “Calibrated” status label with:
   • Calibration Date
   • Next Due Date
   • Calibrated By
7. Attach Calibration Certificate to Equipment File.

5.4 Handling Calibration Failure

1. If deviation is outside acceptance limits:
   • Stop using the balance immediately.
   • Label as “Out of Calibration.”
   • Inform Engineering and QA.
2. Initiate deviation form and investigate impact on batches weighed since last successful calibration.

5.5 Recalibration Schedule

1. Analytical balances: monthly or as per equipment validation protocol.
2. Top-loading/portable balances: quarterly or based on risk assessment.

5.6 Balance ID and Record Maintenance

1. Assign a unique ID to each weighing balance.
2. Maintain a calibration history record for each balance in the Equipment Calibration Register (Annexure-2).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• ID: Identification

7. Documents

1. Daily Calibration Log (Annexure-1)
2. Equipment Calibration Register (Annexure-2)
3. Calibration Certificates
4. Deviation Form (if applicable)

8. References

• 21 CFR Part 211 – Subpart D: Equipment Cleaning and Maintenance
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• USP General Chapter <41> – Weights and Balances

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Daily Calibration Log

Date	Balance ID	Time	Performed By	Result	Remarks
13/04/2025	WB-01	08:30	Rajesh Kumar	Pass	NA

Annexure-2: Equipment Calibration Register

Balance ID	Calibration Date	Due Date	Calibrated By	Certificate No.	Status
WB-01	01/04/2025	01/05/2025	Sunita Reddy	CAL/0425/007	Calibrated

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial Version	New SOP	QA Head
13/04/2025	2.0	Added external calibration procedure & failure handling	Audit Compliance	QA Head