1. Performance Qualification Protocol for Diaphragm Filler
2. Performance Qualification Report for Diaphragm Filler
3. Validation Protocol for Homogeneity of Suspension
4. Validation Report for Homogeneity of Suspension
5. Performance Validation Protocol for Vacuum Crimping Machine
6. Performance Validation Report for Vacuum Crimping Machine
7. Performance Qualification Protocol for Actuator
8. Performance Qualification Report for Actuator
9. Performance Qualification Protocol for Steam Sterilization using Vertical Autoclave
10. Performance Qualification Report for Steam Sterilization using Vertical Autoclave
11. Performance Qualification Protocol for Manufacturing & Filling Process of Metered Dose Inhalers (HFA)
12. Performance Qualification Report for Manufacturing & Filling Process of Metered Dose Inhalers (HFA)
13. Performance Qualification Protocol for 500 ltrs. Vessel with Vibro Mixer
14. Performance Qualification Report for 500 ltrs. Vessel with Vibro Mixer
15. Process Flow Diagram for Aerosol Manufacturing
16. Control Measures In Aerosol For Rejecting Empty Containers

Aerosols Qualification in Pharma: A Practical Overview

Pharmaceutical aerosols are pressurised dosage forms that deliver a fine mist or spray from a container fitted with a valve system, such as inhalers and nasal sprays. Their qualification is critical because product quality depends not only on the formulation, but also on the propellant, container, valve and actuator working together as a system.

From a regulatory point of view, aerosol products must meet both GMP and specific quality expectations for inhalation and nasal products. EU GMP Annex 10 covers manufacture of pressurised metered-dose aerosols for inhalation, emphasising control of filling, crimping, leak testing and metering performance. GMP Compliance The latest EMA guideline on pharmaceutical quality of inhalation and nasal medicinal products further details requirements for pMDIs, DPIs and nasal sprays, including device–drug compatibility, dose delivery and lifecycle management. European Medicines Agency (EMA)+1 FDA guidance on MDI and DPI quality considerations follows a similar risk-based approach. U.S. Food and Drug Administration

In practice, aerosol qualification in pharma covers three broad areas:

1. Formulation and device qualification
   • Compatibility of drug, excipients and propellant
   • Selection of container, valve and actuator to ensure consistent dose delivery
   • Control of particle size distribution for inhalation products
2. Process and line qualification
   • Verification of filling accuracy (net content and propellant weight)
   • Crimp integrity and leak testing (often via water-bath or pressure decay methods)
   • Evaluation of spray pattern and plume geometry to confirm proper performance on the line.
3. In-process and finished product quality control
   Typical tests include:
   • Fill weight / content uniformity
   • Leak test and valve functionality
   • Spray pattern and spray rate
   • Dose uniformity per actuation
   • Flammability and flash-point checks for propellant-based aerosols
   • Stability studies under ICH conditions to support shelf-life.

Robust aerosols qualification shows regulators that every actuation delivers the right dose, at the right performance, for the full shelf-life of the product—protecting both regulatory compliance and patient safety.