Standard Operating Procedure for Validating Pouch Packaging & Seal Integrity Tester
Purpose: This SOP outlines the validation process for the Pouch Packaging & Seal Integrity Tester used in the packaging area for transdermal microneedles and advanced patches, ensuring compliance with industry standards and regulations.
Scope: This procedure applies to the validation of the Pouch Packaging & Seal Integrity Tester within the NDDS category for transdermal microneedles and advanced patches. It covers all phases of validation including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Definitions:
- Equipment/Instrument: Pouch Packaging & Seal Integrity Tester
- Criticality: Critical
- Product Impact: Direct
- CSV: Computer System Validation
Roles:
- Validation Team: Responsible for executing the validation process.
- Quality Assurance: Ensures compliance with regulatory standards.
- Operations: Maintains equipment and performs routine checks.
Lifecycle Procedure:
- Conduct Design Qualification (DQ) to ensure equipment meets user requirements.
- Perform Installation Qualification (IQ) to verify that the equipment is installed correctly.
- Execute Operational Qualification (OQ) to ensure the equipment operates as intended.
- Complete Performance Qualification (PQ) to confirm that the equipment performs effectively with actual product.
GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are complete, accurate, and readily retrievable.
Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirement Specifications (URS) and Annex 11 compliance.
Calibration/PM Governance: The Pouch Packaging & Seal Integrity Tester will undergo calibration and preventive maintenance as per the manufacturer’s recommendations and internal procedures.
Change Control Triggers: Any changes to the equipment, processes, or product specifications that may impact the validation status must be documented and assessed through a change control process.
Revalidation Triggers and Periodic Review: Revalidation will occur annually (12M) or when significant changes are made to the equipment or processes.
Records/Attachments List:
- Validation Protocols
- Calibration Records
- Change Control Documentation
- Periodic Review Reports