Standard Operating Procedure for Bulk Powder Handling

Purpose

The purpose of this SOP is to establish procedures for the safe, efficient, and hygienic handling of bulk powders in the pharmaceutical manufacturing process, ensuring compliance with regulatory standards and product quality.

Scope

This SOP applies to all personnel involved in the handling of bulk powders, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for executing bulk powder handling procedures following established guidelines.
• Technicians: Responsible for monitoring and maintaining equipment used in bulk powder handling processes.
• Quality Control Personnel: Responsible for verifying the quality and compliance of bulk powders through inspections and testing.

Procedure

1. Inspect the bulk powder handling equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, free from residues, and calibrated before starting the handling process.
3. Verify that the bulk powders to be handled are labeled correctly, and their identity and quantity match the specifications.
4. Use appropriate personal protective equipment (PPE) such as gloves, masks, and goggles during the handling process.
5. Load bulk powders into designated equipment, ensuring proper alignment and following weight specifications.
6. Operate equipment according to established procedures, controlling the flow and ensuring a smooth handling process.
7. Monitor environmental conditions such as humidity and temperature to prevent issues like caking or clumping.
8. If adjustments to the handling parameters are necessary, document the changes made and the reason for the adjustments.
9. Perform in-process quality control checks, including visual inspections and sampling for further testing.
10. Collect samples for laboratory analysis to ensure the quality and compliance of the bulk powders.
11. Submit samples to the quality control laboratory, ensuring that the bulk powders meet the predefined acceptance criteria.
12. If the bulk powders pass quality control, proceed with further processing or packaging.
13. If the bulk powders fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
14. Complete the logbook or batch record with all pertinent information, including any adjustments made during the handling process.
15. Clean and sanitize the bulk powder handling equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Handling Logbook
• Quality Control Test Results
• Maintenance and Calibration Records
• Deviation and Corrective Action Logs

Reference

USP General Chapter <1072> – Disintegration and Dissolution of Dietary Supplements

SOP Version

Version 1.0