Auditee: Process validation is a crucial step in ensuring the consistent quality and reliability of critical manufacturing processes. It involves a comprehensive evaluation of processes to demonstrate their capability to consistently produce products that meet predetermined specifications. Here’s an overview of our process validation procedures for critical manufacturing processes:
Stage 1: Process Design
- Process Characterization: Before validation begins, critical process parameters are identified and characterized through scientific analysis and experimentation.
- Design of Experiments (DOE): Statistical techniques, such as DOE, are employed to identify the key factors influencing process outcomes and determine optimal parameter ranges.
- Process Flow and Control: A detailed process flowchart is created,
outlining each step of the manufacturing process. Critical control points and parameters are identified.
Stage 2: Process Qualification
- Installation Qualification (IQ): The equipment used in the process is qualified to ensure it is installed and functioning correctly, meeting operational specifications.
- Operational Qualification (OQ): The process is tested under varying conditions to verify that it consistently produces results within predetermined specifications.
- Performance Qualification (PQ): The process is tested under normal operating conditions using actual product batches to demonstrate its ability to consistently produce products meeting quality standards.
Stage 3: Continued Process Verification
- Monitoring and Control: Ongoing monitoring of critical process parameters and quality attributes is established to ensure the process remains within control limits.
- Statistical Process Control (SPC): SPC tools are employed to detect any deviations from established process performance and take corrective actions.
- Periodic Review: Periodic reviews are conducted to assess the process performance and determine if any modifications or revalidation are necessary due to changes in equipment, materials, or regulations.
Documentation and Reporting
- Validation Protocol: A validation protocol outlines the validation strategy, testing procedures, acceptance criteria, and roles and responsibilities of the validation team.
- Validation Report: A validation report summarizes the results of each validation stage, including any deviations encountered, corrective actions taken, and overall conclusions.
Through these systematic process validation procedures, we ensure that critical manufacturing processes consistently produce high-quality products that meet regulatory requirements and exceed customer expectations.