Regulatory Open Forum

Regarding the attachment from GMP storage for API, it encompasses a comprehensive set of documentation and records detailing the storage procedures, conditions, and controls implemented in accordance with Good Manufacturing Practice guidelines. These documents typically include temperature logs, humidity records, inventory management records, and any deviations or corrective actions taken to maintain the quality and integrity of the stored APIs. Adhering to these stringent storage practices is crucial to ensure the potency, safety, and efficacy of the active pharmaceutical ingredients throughout their lifecycle within the manufacturing process.