The Nasal Spray and Inhalation Dosage Form plays a critical role in the pharmaceutical industry, offering a fast and efficient drug delivery method to local and/or systemic circulation. Nasal spray drug products contain drug substances dissolved or suspended in solutions or mixtures of excipients in nonpressurized dispensers that deliver a spray containing a metered dose of the active ingredient.
Inhalation solution and suspension drug products are typically aqueous-based formulations. Inhalation solutions and suspensions are intended for delivery to the lungs by oral inhalation for local and/or systemic effects and are to be used with a specified nebulizer. The importance of a Nasal Spray and Inhalation Checklist lies in ensuring the safety, quality, and efficacy of the product, meeting the stringent standards of regulatory bodies
The Checklist serves as a proactive tool to confirm that the manufacturing, testing, and packaging processes adhere to current Good Manufacturing Practices (cGMP) and relevant guidelines. By ensuring full compliance, companies can enhance the credibility of their submissions, reduce the risk of deficiencies during regulatory reviews, and foster smoother market approvals. This structured approach to compliance supports the successful commercialization of nasal spray/inhalation products, providing patients with reliable, high-quality medications for immediate