Standard Operating Procedure for Equipment Validation of Dispensing Booth (Downflow)
Purpose: This SOP outlines the validation process for the Dispensing Booth (Downflow) used for weighing and dispensing solid dosage forms under containment in the production area.
Scope: This procedure applies to all personnel involved in the validation of the Dispensing Booth in the production/dispensing area. It covers the entire lifecycle of the equipment from Design Qualification (DQ) to Performance Qualification (PQ).
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- URS: User Requirement Specification
Roles:
- Validation Team: Responsible for executing the validation protocol.
- Quality Assurance: Ensures compliance with regulatory standards.
- Production Personnel: Operate the equipment and provide feedback during validation.
Lifecycle Procedure:
- Design Qualification (DQ): Document and review user requirements.
- Installation Qualification (IQ): Verify that the equipment is installed according to specifications.
- Operational Qualification (OQ): Test the equipment under operational conditions.
- Performance Qualification (PQ): Ensure the equipment performs consistently within specified limits.
GDP Controls: Good Documentation Practices must be followed throughout the validation process. All records must be clear, concise, and maintained in a controlled manner.
Acceptance Criteria Governance: Acceptance criteria will be derived from the User Requirement Specification (URS) and must comply with ISO 14644 Annex 15 standards.
Calibration/PM Governance: The Dispensing Booth must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal SOPs.
Change Control Triggers: Any changes to the equipment, processes, or materials must initiate a change control process to assess the impact on validation status.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur that may affect the equipment’s performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Records
- Maintenance Logs