Document Control
Document ID: OQ-CP-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for Capsule Polisher
Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Capsule Polisher used in solid dosage form production, detailing objectives, scope, responsibilities, and test plans.
Tags: Equipment Validation, Capsule Polisher, OQ Protocol, Pharmaceutical Industry
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Capsule Polisher operates within specified limits and meets all acceptance criteria defined in the User Requirement Specification (URS).
Scope
This protocol applies to the Capsule Polisher used in the production area for polishing and dedusting capsules, impacting product quality directly.
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 necessary operational support.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of necessary materials and equipment.
- Training of personnel on equipment operation.
Equipment Description
The Capsule Polisher is designed to polish and remove dust from capsules post-manufacturing. It operates using controlled airflow and speed settings to minimize capsule damage while ensuring effective cleaning.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-CP-01 | Verify speed settings at maximum and minimum. | Speed should not exceed manufacturer specifications. | Calibration logs, test records. |
| OQ-CP-02 | Measure airflow rate during operation. | Airflow must be within specified range. | Measurement logs, airflow meter records. |
| OQ-CP-03 | Inspect capsules for damage post-polishing. | No more than 2% of capsules should show signs of damage. | Inspection records, photographic evidence. |
Detailed Test Cases
Test Case OQ-CP-01: Verify Speed Settings
Objective: Ensure that the speed settings of the Capsule Polisher are functioning within the specified limits.
Procedure: Adjust the speed to maximum and minimum settings. Record the actual speed displayed.
Acceptance Criteria: Speed should not exceed manufacturer specifications.
Expected Result: Documented speed readings within acceptable limits.
Test Case OQ-CP-02: Measure Airflow Rate
Objective: Confirm that the airflow rate is consistent and within the specified range.
Procedure: Use an airflow meter to measure the airflow during operation.
Acceptance Criteria: Airflow must be within specified range.
Expected Result: Recorded airflow rates meet acceptance criteria.
Test Case OQ-CP-03: Inspect Capsules for Damage
Objective: Evaluate the integrity of capsules post-polishing.
Procedure: Randomly select a batch of capsules and inspect for visible damage.
Acceptance Criteria: No more than 2% of capsules should show signs of damage.
Expected Result: Documented inspection results indicating damage percentage.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals
This protocol must be reviewed and approved by the Quality Assurance department prior to execution.