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 applies to all personnel involved in analytical method development activities within the MDI production facility, including analytical chemists, validation specialists, and quality control personnel.

3) Responsibilities

The responsibilities for this SOP include designing method development experiments, validating analytical methods, and documenting method development and validation activities. Specific roles include:
Analytical Chemists: Conduct experiments and optimize analytical methods for MDI testing.
Validation Specialists: Validate developed methods to ensure accuracy, precision, and reproducibility.
Quality Control Personnel: Implement validated methods for routine testing and quality assurance.

4) Procedure

4.1 Method Development
4.1.1 Define method development objectives and critical quality attributes (CQAs) to be measured.
4.1.2 Conduct preliminary experiments and feasibility studies to select suitable analytical techniques.
4.2 Optimization and Validation
4.2.1 Optimize analytical methods for sensitivity, selectivity, accuracy, and precision.
4.2.2 Validate developed methods following regulatory guidelines and acceptance criteria.
4.3 Documentation
4.3.1 Document method development experiments, optimization steps, and validation protocols.
4.3.2 Prepare method validation reports summarizing validation results, conclusions, and any deviations encountered.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
CQAs: Critical Quality Attributes

6) Documents, if any

Method development protocols, method validation reports, experimental data, and optimization records should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for analytical method development and validation requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0