Formulation Development Procedures for MDIs
1) Purpose
The purpose of this SOP is to establish procedures for the formulation development of metered-dose inhalers (MDIs) to achieve desired product performance, stability, and compatibility with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in formulation development activities within the MDI production facility, including formulation scientists, analytical chemists, and quality assurance personnel.
3) Responsibilities
The responsibilities for this SOP include conducting formulation experiments, analyzing results, optimizing formulations, and documenting formulation development activities. Specific roles include:
Formulation Scientists: Develop and optimize MDI formulations based on product requirements and objectives.
Analytical Chemists: Analyze formulation components and assess product stability and compatibility.
Quality Assurance Personnel: Review and approve formulation development protocols and reports.
4) Procedure
4.1 Formulation Design
4.1.1 Define formulation objectives, including active ingredient concentration, excipients, and propellant selection.
4.1.2 Conduct preliminary studies and literature reviews to inform formulation design.
4.2 Experimental Formulation
4.2.1 Prepare experimental formulations based on initial design parameters and feasibility studies.
4.2.2 Document formulation compositions, manufacturing processes, and critical parameters.
4.3 Stability Studies
4.3.1 Perform stability testing on formulated MDIs under accelerated and real-time conditions.
4.3.2 Evaluate physical and chemical stability, potency, and compatibility with packaging materials.
4.4 Optimization and Scale-Up
4.4.1 Optimize formulations based on stability and performance results.
4.4.2 Scale up optimized formulations for pilot batches and manufacturing trials.
4.5 Documentation and Reporting
4.5.1 Maintain comprehensive records of formulation development activities, including protocols, test results, and conclusions.
4.5.2 Prepare formulation development reports summarizing formulation strategies, experimental data, and outcomes.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Formulation development protocols, stability study reports, formulation optimization records, and formulation development reports should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for formulation development requirements in pharmaceutical manufacturing.
8) SOP Version
Version 1.0
