Standard Operating Procedure for Process Validation
1) Purpose
The purpose of this SOP is to outline the procedures for validating manufacturing processes to ensure they consistently produce products meeting predetermined quality attributes.
2) Scope
This SOP applies to all manufacturing processes within the facility that require validation, including new processes, changes to existing processes, and routine re-validation.
3) Responsibilities
3.1 Validation Manager
– Develop and approve validation protocols and reports.
– Oversee execution of validation activities.
3.2 Production Personnel
Execute validation protocols under specified conditions.
Record data accurately during validation runs.
3.3 Quality Assurance (QA) Personnel
Review and approve validation documentation.
Ensure compliance with regulatory and internal quality requirements.
4) Procedure
4.1 Validation Planning
4.1.1 Identify processes requiring validation based on risk assessment and regulatory requirements.
4.1.2 Develop a validation master plan outlining the scope, strategy, and schedule of validation activities.
4.2 Protocol Development
4.2.1 Draft validation protocols specifying the objective, scope, acceptance criteria, and methodology.
4.2.2 Obtain approval from QA and relevant stakeholders before execution.
4.3 Execution of Validation Runs
4.3.1 Conduct validation runs according to the approved protocol.
4.3.2 Monitor critical process parameters and record data meticulously.
4.4 Data Analysis
4.4.1 Analyze validation data to verify that the process consistently produces quality products.
4.4.2 Identify and investigate any deviations from acceptance criteria.
4.5 Report Preparation
4.5.1 Compile validation data and findings into a comprehensive report.
4.5.2 Review and approve the validation report, documenting conclusions and recommendations.
4.6 Re-validation
4.6.1 Perform re-validation periodically or when significant changes occur in the process or product.
4.6.2 Follow the same procedures as initial validation for re-validation activities.
5) Abbreviations, if any
– QA: Quality Assurance
6) Documents, if any
– Validation Master Plan
– Validation Protocols
– Validation Reports
7) Reference, if any
– FDA Guidance for Industry: Process Validation: General Principles and Practices
– ICH Q8(R2): Pharmaceutical Development
8) SOP Version
Version 1.0
