Operational Qualification Protocol for Capsule Checkweigher

Objective

The objective of this Operational Qualification (OQ) protocol is to verify that the Capsule Checkweigher operates within predefined limits and meets the specified requirements for weight verification in the production of solid dosage forms.

Scope

This protocol applies to the Capsule Checkweigher utilized in the Production area for weight verification of capsules. It covers the critical parameters that impact product quality and compliance with regulatory standards.

Responsibilities

• Validation Team: Responsible for executing the protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the protocol and results.
• Production Team: Responsible for providing access to the equipment and assisting in the execution of the protocol.

Prerequisites

• Completion of Installation Qualification (IQ).
• Availability of all necessary equipment and materials.
• Training of personnel on the operation of the Capsule Checkweigher.

Equipment Description

The Capsule Checkweigher is designed to verify the weight of capsules during the production process. It features an accuracy reject mechanism and maintains an audit trail for all weight measurements.

Test Plan

Detailed Test Cases

Test Case OQ-01: Verify Accuracy of Weight Measurements

Procedure: Use calibrated weights to test the Capsule Checkweigher for accuracy. Document the weight readings and compare them to the target weight.

Acceptance Criteria: All readings must be within ±5% of the target weight.

Evidence: Calibration certificate and measurement logs will be attached to this protocol.

Test Case OQ-02: Audit the Reject Mechanism Functionality

Procedure: Introduce out-of-spec weights and verify that the Capsule Checkweigher properly rejects these capsules. Document the reject actions.

Acceptance Criteria: The reject mechanism must function correctly and log all actions in the audit trail.

Evidence: The audit trail report will be attached to this protocol.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed, and corrective actions will be implemented as necessary.

Approvals

Prepared By: ______________________ Date: ___________

Approved By: ______________________ Date: ___________

Data Integrity Checks

As the CSV is required, the following data integrity checks will be performed:

• Verification of data entry processes to ensure accuracy and completeness.
• Regular audits of the audit trail to confirm that the reject mechanism is functioning correctly.
• Backup procedures for data storage and retrieval.