Capsule/Blister Filler for DPI – IQ Protocol

Document Control:

Document ID: IQ-001

Version: 1.0

Effective Date: [Insert Date]

Prepared by: [Insert Name]

Approved by: [Insert Name]

Installation Qualification Protocol for Capsule/Blister Filler for DPI

Objective: To ensure the Capsule/Blister Filler for DPI is installed correctly and operates as intended, meeting all critical parameters outlined in the URS Annex11.

Scope: This protocol applies to the installation qualification of the Capsule/Blister Filler for DPI in the Production area, specifically for filling inhalation powder dose units.

Responsibilities:

  • Validation Team: Responsible for executing the IQ protocol and documenting results.
  • Quality Assurance: Responsible for reviewing and approving the protocol and results.
  • Maintenance Team: Responsible for ensuring the equipment is installed according to manufacturer specifications.

Prerequisites:

  • Completion of equipment installation by the Maintenance Team.
  • Training of personnel on equipment operation.
  • Availability of relevant documentation (URS, equipment manuals, etc.).

Equipment Description: The Capsule/Blister Filler for DPI is designed to fill inhalation powder dose units with engineered particles, ensuring consistent fill weight and meeting GMP standards.

Test ID Procedure Acceptance Criteria Evidence
IQ-01 Verify installation according to manufacturer’s specifications. All components installed as per specifications. Installation checklist signed off by Maintenance.
IQ-02 Check fill weight uniformity. Fill weight within specified limits. Weight measurement records.
IQ-03 Audit trail for reject logic. Audit trail reflects all reject logic events. Audit trail report generated.
See also  Drying Oven / Drying Tunnel – Equipment Validation SOP

Detailed Test Cases:

  • Test Case IQ-01: Confirm all equipment components are installed as per the manufacturer’s guidelines. Document any discrepancies found during the inspection.
  • Test Case IQ-02: Conduct fill weight tests on multiple samples to verify uniformity. Document results and ensure all samples meet the defined acceptance criteria.
  • Test Case IQ-03: Review the audit trail for reject logic to ensure it captures all relevant events. Document any missing entries or discrepancies.

Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be implemented for any critical failures.

Approvals:

  • Validation Team Lead: ______________________ Date: __________
  • Quality Assurance Manager: ______________________ Date: __________

Data Integrity Checks:

  • Ensure all data entries are timestamped and attributed to the responsible operator.
  • Regular audits of the audit trail to verify data consistency.
  • Backup of data logs to prevent loss of information.

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