Process Validation Procedures for MDIs
1) Purpose
The purpose of this SOP is to establish procedures for conducting process validation for the manufacturing of metered-dose inhalers (MDIs) to ensure consistency, reliability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in process validation activities within the MDI production facility, including production engineers, quality assurance personnel, and validation specialists.
3) Responsibilities
The responsibilities for this SOP include planning validation studies, executing validation protocols, analyzing validation data, and documenting validation activities. Specific roles include:
Production Engineers: Implement validated processes in production operations.
Quality Assurance Personnel: Review and approve validation protocols and reports.
Validation Specialists: Conduct validation studies and analyze validation data.
4) Procedure
4.1 Process Validation Planning
4.1.1 Define the scope and objectives of process validation studies.
4.1.2 Identify critical process parameters (CPPs) and critical quality attributes (CQAs).
4.2 Protocol Development
4.2.1 Develop validation protocols detailing study objectives, test methods, acceptance criteria, and sampling plans.
4.2.2 Obtain approval of validation protocols from relevant stakeholders.
4.3 Process Qualification
4.3.1 Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as applicable.
4.3.2 Document and analyze qualification results to ensure process capability and equipment performance.
4.4 Continued Process Verification
4.4.1 Implement a strategy for ongoing monitoring and verification of validated processes.
4.4.2 Collect and analyze data to confirm continued process control and product quality.
4.5 Validation Reporting
4.5.1 Prepare validation reports summarizing study results, conclusions, and any deviations encountered.
4.5.2 Archive validation documentation for future reference and regulatory inspections.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
CPPs: Critical Process Parameters
CQAs: Critical Quality Attributes
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
6) Documents, if any
Validation protocols, qualification reports, process validation reports, and ongoing monitoring plans should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for process validation requirements in pharmaceutical manufacturing.
8) SOP Version
Version 1.0
