Standard Operating Procedure for Weight Variation Control

Purpose

The purpose of this SOP is to establish procedures for controlling and monitoring weight variation in pharmaceutical products, ensuring compliance with regulatory standards and maintaining product quality.

Scope

This SOP applies to all personnel involved in the manufacturing and quality control of pharmaceutical products, specifically those responsible for weighing and dispensing operations.

Responsibilities

• Operators: Responsible for accurately weighing and dispensing materials according to established procedures.
• Quality Control Personnel: Responsible for monitoring and verifying weight variations in finished products.

Procedure

1. Inspect weighing equipment for any visible damage or defects before each use.
2. Ensure that weighing equipment is clean, calibrated, and meets the specifications for the intended use.
3. Verify the accuracy of reference weights used in the calibration process.
4. Calibrate weighing equipment regularly as per the approved calibration schedule.
5. Perform linearity checks to ensure the accuracy of weighing equipment across the specified range.
6. Use calibrated weighing equipment to dispense materials according to the approved batch record or formulation.
7. Record the actual weights of materials dispensed and compare them with the target weights specified in the batch record.
8. Calculate and document the percentage deviation from the target weight for each dispensed material.
9. Ensure that the weight variation is within the acceptable limits defined in the relevant standard operating procedures or regulatory guidelines.
10. Document any out-of-specification (OOS) results and report them to the quality control department for investigation.
11. Implement corrective actions for identified deviations and prevent reoccurrence of weight variations.
12. Maintain accurate records of weight variation for each batch in the designated logbook or electronic system.
13. Review weight variation data periodically to identify trends or patterns that may require process adjustments.
14. Train personnel involved in weighing operations on proper procedures, equipment usage, and the importance of weight variation control.
15. Archive weight variation records in accordance with established retention policies.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Calibration Records
• Weight Variation Logbook
• Deviation and Corrective Action Logs

Reference

USP General Chapter <41> – Balances

SOP Version

Version 1.0