FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - April 02, 2024

This FDA Form 483 document details observations from an inspection concerning procedures designed to prevent microbiological contamination of sterile drug products. The facility in question utilizes Building 8 Room 9 for filling finished drug product vials.

A key observation is that the aseptic process validation, specifically the most recent smoke study conducted on September 8, 2021, did not accurately simulate actual processing conditions. Video recordings from this smoke study show an operator responsible for loading the lyophilizer standing and working within the unidirectional airflow pattern of the hood. Furthermore, a second operator was observed using the same hood for aseptic manipulations, including removing sterile stoppers from sterile plates, while the first operator was standing approximately 50 cm or less from the unidirectional airflow pattern.

The document notes that the firm has released drug products for commercial distribution in the U.S. since this inadequately conducted smoke study. This indicates a potential deficiency in the quality system and manufacturing controls related to aseptic processing and contamination prevention. The regulatory implication is that the procedures for preventing microbiological contamination of sterile drug products are not adequately validated, potentially impacting product sterility and patient safety.