Standard Operating Procedure for Filling Accuracy and Volume Checks

1) Purpose

The purpose of this SOP is to outline procedures for verifying the accuracy and volume of filled products during pharmaceutical manufacturing to ensure compliance with specifications and regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the filling and quality control of pharmaceutical products within the manufacturing facility.

3) Responsibilities

3.1 Production Operators

• Perform filling operations according to approved procedures.
• Monitor equipment performance during filling processes.

3.2 Quality Control (QC) Analysts

• Conduct volume checks and accuracy tests on filled products.
• Document and report any deviations or non-conformities.

4) Procedure

4.1 Pre-Filling Checks

1. Verify equipment calibration and readiness.
2. Inspect filling components for cleanliness and integrity.

4.2 Filling Operation

1. Initiate filling process according to batch record instructions.
2. Monitor and adjust equipment settings as necessary.

4.3 Volume Verification

1. Collect filled product samples for volume measurement.
2. Use calibrated measuring devices to confirm filled volumes.

4.4 Accuracy Testing

1. Perform statistical sampling of filled products.
2. Compare measured volumes against target specifications.

4.5 Documentation and Reporting

1. Record filling and testing results in batch records.
2. Report any deviations or quality issues to supervisors and QA.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QC: Quality Control

6) Documents, if any

• Filling Batch Records
• Volume Measurement Logs
• Accuracy Testing Reports

7) Reference, if any

USP General Chapter <905>: Uniformity of Dosage Units
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0