SOP for Use of Stabilizers in MDI Production Stabilizer Handling Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for the use of stabilizers in metered-dose inhaler (MDI) production to ensure product stability, efficacy, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in…

SOP for Use of Propellants in MDI Production Propellant Handling Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for the safe handling and use of propellants in metered-dose inhaler (MDI) production to ensure operator safety, product quality, and compliance with regulatory requirements. 2) Scope This SOP applies to…

SOP for Color Consistency Testing in MDIs Color Consistency Testing Procedures in MDIs 1) Purpose The purpose of this SOP is to establish procedures for testing the color consistency of metered-dose inhalers (MDIs) to ensure uniform appearance and product quality. 2) Scope This SOP applies to all personnel involved in color consistency testing activities within…

SOP for Preservative Efficacy Testing in MDIs Preservative Efficacy Testing Procedures in MDIs 1) Purpose The purpose of this SOP is to establish procedures for evaluating the efficacy of preservatives used in metered-dose inhalers (MDIs) to prevent microbial growth and ensure product safety and stability. 2) Scope This SOP applies to all personnel involved in…

SOP for Propellant Testing in MDIs Propellant Testing Procedures in MDIs 1) Purpose The purpose of this SOP is to establish procedures for the testing of propellants used in metered-dose inhalers (MDIs) to ensure their quality, safety, and compatibility with product formulations. 2) Scope This SOP applies to all personnel involved in propellant testing activities…

SOP for Assay of Active Ingredient in MDIs Assay Procedures for Active Ingredient in MDIs 1) Purpose The purpose of this SOP is to establish procedures for the assay of the active ingredient in metered-dose inhalers (MDIs) to determine its concentration and ensure product quality and consistency. 2) Scope This SOP applies to all personnel…

SOP for Homogeneity Testing in MDIs Homogeneity Testing Procedures for MDIs 1) Purpose The purpose of this SOP is to establish procedures for conducting homogeneity testing of metered-dose inhalers (MDIs) to ensure uniform distribution of active ingredients throughout the product batch. 2) Scope This SOP applies to all personnel involved in homogeneity testing activities within…

SOP for Sample Collection for Quality Testing in MDIs Sample Collection Procedures for Quality Testing in MDIs 1) Purpose The purpose of this SOP is to establish procedures for the collection of samples during the manufacturing of metered-dose inhalers (MDIs) for subsequent quality testing to ensure product quality and compliance with specifications. 2) Scope This…

SOP for Analytical Method Development for MDIs Analytical Method Development Procedures for MDIs 1) Purpose The purpose of this SOP is to establish procedures for the development and validation of analytical methods used in the testing and analysis of metered-dose inhalers (MDIs) to ensure accurate and reliable measurement of critical quality attributes. 2) Scope This…

SOP for Process Optimization for MDIs Process Optimization Procedures for MDIs 1) Purpose The purpose of this SOP is to establish procedures for optimizing the manufacturing processes of metered-dose inhalers (MDIs) to improve efficiency, product quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in process optimization activities within…