Standard Operating Procedure for Validating Tablet/Capsule Counter Fillers
Purpose: This SOP outlines the validation process for the Tablet/Capsule Counter Filler to ensure it operates consistently and meets regulatory standards.
Scope: This procedure applies to the validation of the Tablet/Capsule Counter Filler used in the Packaging/Primary area for counting and filling solid dosage forms into bottles.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computerized System Validation
Roles:
- Validation Team: Responsible for executing and documenting the validation process.
- Quality Assurance: Ensures compliance with regulatory requirements and review of validation documentation.
- Maintenance Team: Performs routine maintenance and calibration of the equipment.
Lifecycle Procedure:
- Conduct Design Qualification (DQ) to confirm that the 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 under normal operating conditions.
- Carry out Performance Qualification (PQ) to validate that the equipment consistently performs its intended function.
GDP Controls: Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring that all records are complete, accurate, and legible.
Acceptance Criteria Governance: Acceptance criteria shall be defined in the User Requirement Specification (URS) and shall comply with Annex 11 of the relevant regulations.
Calibration/PM Governance: The Tablet/Capsule Counter Filler must undergo routine calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies.
Change Control Triggers: Any changes to the equipment, process, or product that may affect the validation status must be evaluated through a formal change control process.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur that may impact equipment performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Records
- Training Records