Standard Operating Procedure for Drying Process

Purpose

The purpose of this SOP is to establish procedures for the effective and controlled drying of materials, ensuring consistency, quality, and compliance with regulatory standards.

Scope

This SOP applies to all personnel involved in the drying process, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for executing the drying process according to the established procedures.
• Technicians: Responsible for monitoring and maintaining drying equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for monitoring and ensuring compliance with the drying SOP.

Procedure

1. Inspect the drying equipment for any visible damage or defects before each use.
2. Ensure that the drying equipment is clean, free from residues, and calibrated before starting the drying process.
3. Verify that all materials to be dried are properly labeled and approved for use.
4. Load the materials into the drying equipment, ensuring proper spacing for effective drying and preventing material degradation.
5. Set the drying parameters on the equipment, including temperature, airflow, and drying time, according to the approved specifications.
6. Initiate the drying process and monitor the equipment to ensure uniform drying and adherence to the specified parameters.
7. Perform periodic checks on the drying materials to ensure the desired moisture content is achieved.
8. If adjustments to the drying parameters are necessary, document the changes made and the reason for the adjustments.
9. Perform in-process checks, such as moisture content analysis or visual inspections, to assess the quality of the dried materials.
10. Upon completion of the drying process, allow the equipment to cool before unloading the dried materials.
11. Inspect the dried materials for visual defects or inconsistencies and document the findings.
12. Submit samples to the quality control laboratory for analysis, ensuring that the dried materials meet the predefined acceptance criteria.
13. If the materials pass quality control, proceed with further processing steps as per the formulation requirements.
14. If the materials fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
15. Complete the logbook or batch record with all pertinent information, including any adjustments made during the drying process.
16. Clean and sanitize the drying equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

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

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0