Standard Operating Procedure for Coating Process

Purpose

The purpose of this SOP is to establish procedures for the coating of pharmaceutical products, ensuring consistency, quality, and compliance with regulatory standards.

Scope

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

Responsibilities

• Operators: Responsible for executing the coating process according to the established procedures.
• Technicians: Responsible for monitoring and maintaining coating equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for inspecting and testing coated products to ensure compliance with specifications.

Procedure

1. Inspect the coating 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 coating process.
3. Verify that the coating solution is prepared according to the approved formulation and specifications.
4. Load the products into the coating machine, ensuring proper spacing and alignment for even coating.
5. Adjust the coating parameters (temperature, airflow, etc.) as specified in the approved coating process.
6. Initiate the coating process and monitor the machine to ensure uniform coating application.
7. Perform periodic checks on coated products to ensure quality and consistency.
8. If adjustments to the coating parameters are necessary, document the changes made and the reason for the adjustments.
9. Perform in-process quality control checks, including visual inspections and coating thickness measurements.
10. Collect samples for additional quality control testing, including dissolution testing if applicable.
11. Submit samples to the quality control laboratory, ensuring that the coated products meet the predefined acceptance criteria.
12. If the coated products pass quality control, proceed with further processing steps as per the formulation requirements.
13. If the coated products 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 coating process.
15. Clean and sanitize the coating equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

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

Reference

USP General Chapter <1176> – Pharmaceutical Excipients

SOP Version

Version 1.0