1. Purpose
- To outline the approach and procedures for validating systems, processes, and equipment to ensure compliance with regulatory requirements and to meet predefined quality standards.
2. Scope
- This SOP applies to all validation activities conducted within the organization, including but not limited to, equipment, processes, software, and systems validation.
3. Responsibilities
- Quality Assurance (QA):
- Develops and maintains the Validation Master Plan (VMP).
- Ensures compliance with regulatory requirements.
- Validation Team:
- Executes validation protocols according to the VMP.
- Documents validation activities and results.
- Project Managers:
- Ensure that validation activities are incorporated into project plans.
- Provide necessary resources for validation activities.
4. Validation Master Plan Development
- 4.1 Preparation:
- Identify all systems, processes, and equipment requiring validation.
- Determine validation approach (e.g., prospective, retrospective, concurrent).
- 4.2 Documenting:
- Develop the VMP document outlining validation strategy, roles, responsibilities, and timelines.
- Obtain approval from relevant stakeholders.
- 4.3 Review and Update:
- Review and update the VMP periodically or as required to reflect changes in processes, equipment, or regulations.
5. Validation Protocol Development
- 5.1 Protocol Preparation:
- Define validation objectives, acceptance criteria, and testing methodologies.
- Draft validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)).
- 5.2 Review and Approval:
- Review protocols by the validation team and QA.
- Obtain approval from relevant stakeholders before execution.
6. Validation Execution
- 6.1 IQ Execution:
- Verify that equipment is installed correctly and according to specifications.
- Document deviations and corrective actions.
- 6.2 OQ Execution:
- Test equipment to ensure it operates within defined parameters.
- Document test results and any deviations.
- 6.3 PQ Execution:
- Validate equipment performance under actual operating conditions.
- Document test results, deviations, and corrective actions.
7. Validation Documentation
- 7.1 Protocol Reports:
- Compile protocol reports including test results, deviations, and conclusions.
- Obtain approval from relevant stakeholders.
- 7.2 Summary Reports:
- Consolidate protocol reports into summary reports.
- Include recommendations for validation acceptance or further actions.
- 7.3 Archiving:
- Archive validation documentation as per company procedures.
8. Change Control
- 8.1 Evaluation:
- Assess the impact of proposed changes on validated systems.
- Determine if revalidation is necessary.
- 8.2 Documentation:
- Document all changes and their impact on validation status.
- Update validation documentation as required.
9. Training
- 9.1 Training Needs Assessment:
- Identify training needs for personnel involved in validation activities.
- Provide training on validation procedures, protocols, and documentation.
- 9.2 Competency Assessment:
- Assess personnel competency in executing validation activities.
- Provide additional training or support as necessary.
10. Compliance and Audit
- 10.1 Compliance Monitoring:
- Monitor validation activities to ensure compliance with regulatory requirements and internal standards.
- 10.2 Audit Preparation:
- Prepare validation documentation for internal and external audits.
- Address any findings or non-conformities identified during audits.
11. Records Management
- 11.1 Documentation Retention:
- Maintain records of all validation activities, including protocols, reports, and approvals.
- 11.2 Record Accessibility:
- Ensure validation records are easily accessible for review and audit purposes.
- 11.3 Record Archiving:
- Archive validation records according to company policies and regulatory requirements.
12. References
- List relevant standards, regulations, and guidelines governing validation activities.
13. Definitions
- Provide definitions for terms used in the VMP to ensure clarity and consistency.
14. Appendices
- Include any additional documents or templates referenced in the VMP.
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