Page 1 Image
Company Logo
ANDA Review Checklist MDI & DPI Dosage Form
Product Name:

IMPORTANCE OF METERED DOSE INHALER (MDI) AND DRY POWDER INHALER (DPI) DOSAGE FORM CHECKLIST

      In the pharmaceutical industry, Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs) are critical dosage forms, especially for delivering medications to treat lung diseases characterized by obstruction of airflow and shortness of breath, including asthma and chronic obstructive pulmonary disease (COPD), as well as respiratory infections and cystic fibrosis. A comprehensive checklist for MDIs and DPIs plays a vital role in ensuring the consistency, quality, and regulatory compliance of these products throughout their lifecycle.

        The checklist allows for multi-departmental reviews, enhancing the robustness of product development and compliance processes. The checklist ensures proper documentation of critical parameters, including device performance. Adhering to the checklist mitigates the risk by verifying that every aspect of the manufacturing, stability testing, and performance criteria align with regulatory expectations.

       This proactive compliance approach strengthens the credibility of submissions, facilitates faster regulatory approval, and supports successful commercialization. Moreover, ensuring high-quality inhaler products directly enhances patient trust and satisfaction, ultimately driving better health outcomes and market performance