Standard Operating Procedure for Capsule Filled Weight Check

Purpose

The purpose of this SOP is to establish procedures for the systematic and accurate checking of filling weights during pharmaceutical manufacturing, 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 filling operations and weight verification.

Responsibilities

• Operators: Responsible for executing procedures related to the filling of pharmaceutical products.
• Quality Control Personnel: Responsible for monitoring and verifying filling weights for compliance.

Procedure

1. Inspect filling equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, calibrated, and set up according to the approved process parameters for filling.
3. Verify the quality and specifications of raw materials used in the filling process.
4. During filling operations, monitor and document key process parameters, including but not limited to fill speed, fill volume, and container integrity.
5. Collect samples at specified intervals during the filling process for subsequent weight verification.
6. Use calibrated weighing equipment to perform weight checks on filled containers, ensuring accuracy and precision.
7. Record the results of filling weight checks, including any deviations from the predefined specifications, in the designated logbook or electronic system.
8. If filling weights are out of specification, segregate and document affected units, and initiate an investigation to determine the root cause.
9. Implement corrective actions based on the findings of the investigation to prevent the recurrence of filling weight deviations.
10. For finished batches, ensure that the required sampling plan for filling weight checks is followed, and document the results accordingly.
11. Document any out-of-specification (OOS) results, initiate an investigation, and implement corrective actions as needed.
12. Archive filling weight check records in accordance with established retention policies.
13. Regularly review and update filling weight check procedures based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Filling Weight Check Logbook
• Calibration Records
• Validation Reports
• Deviation and Corrective Action Logs

Reference

USP General Chapter <41> – Balances

SOP Version

Version 1.0