Standard Operating Procedure for Equipment Validation of Capsule/Blister Filler for DPI
Purpose: This SOP outlines the validation process for the Capsule/Blister Filler used in the production of inhalation powder dose units, ensuring compliance with regulatory standards and product quality.
Scope: This procedure applies to the validation of the Capsule/Blister Filler for DPI in the Production area, covering all aspects from Design Qualification (DQ) to Performance Qualification (PQ).
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computerized System Validation
Roles:
- Validation Team: Responsible for executing validation activities.
- Quality Assurance: Ensures compliance with regulatory requirements.
- Production Personnel: Operate the equipment and provide input during validation.
Lifecycle Procedure:
- Conduct Design Qualification (DQ) to establish equipment specifications.
- Perform Installation Qualification (IQ) to verify proper installation.
- Execute Operational Qualification (OQ) to confirm equipment operates within specified limits.
- Carry out Performance Qualification (PQ) to validate the equipment’s performance in actual production conditions.
GDP Controls: Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are complete, accurate, and traceable.
Acceptance Criteria Governance: Acceptance criteria will be governed as per URS Annex 11, ensuring that all specifications meet the required standards for product impact.
Calibration/PM Governance: Regular calibration and preventive maintenance must be scheduled and documented to ensure ongoing compliance and functionality of the equipment.
Change Control Triggers: Any changes to equipment, processes, or materials must initiate a change control process, including re-evaluation of validation status.
Revalidation Triggers and Periodic Review: Revalidation is required annually or upon significant changes to equipment or processes. A periodic review will assess the need for revalidation based on performance data and regulatory changes.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Documentation
- Periodic Review Reports