Performance Qualification Protocol for Inline Particle Size Analyzer in NDDS – Long-Acting Injectables

Objective

The objective of this Performance Qualification (PQ) protocol is to establish that the Inline Particle Size Analyzer (PAT) performs consistently and reliably within specified limits for monitoring particle size in the production of Long-Acting Injectables (Depot Suspensions).

Scope

This protocol applies to the Inline Particle Size Analyzer used in the production area for the assessment of particle size in Long-Acting Injectables. It encompasses all procedures necessary to validate the performance of the equipment in compliance with regulatory requirements.

Responsibilities

• Validation Team: Responsible for the execution and documentation of the PQ protocol.
• Quality Assurance: Responsible for reviewing and approving the PQ protocol and its results.
• Production Personnel: Responsible for the operation of the Inline Particle Size Analyzer during PQ activities.

Prerequisites

• Completion of Installation Qualification (IQ) and Operational Qualification (OQ) for the Inline Particle Size Analyzer.
• Availability of necessary reagents and materials for testing.
• Training of personnel on the use of the Inline Particle Size Analyzer.

Equipment Description

The Inline Particle Size Analyzer (PAT) is a device used to measure the particle size distribution of suspensions in real-time during the production process. It ensures that the particle size remains within defined specifications, which is critical for the efficacy of Long-Acting Injectables.

Test Plan

Detailed Test Cases

Test Case 1: Calibration Verification

• Procedure: Use standard calibration particles to verify the accuracy of the Inline Particle Size Analyzer.
• Acceptance Criteria: The analyzer must display results within ±5% of the known particle size.
• Evidence: Calibration logs and results must be documented.

Test Case 2: Control Sample Measurement

• Procedure: Measure particle size of established control samples.
• Acceptance Criteria: Results must fall within pre-defined specifications for each control sample.
• Evidence: Documented results of control sample measurements.

Test Case 3: Data Integrity Checks

• Procedure: Review the audit trail for any discrepancies or unauthorized changes.
• Acceptance Criteria: Audit trail must show no alterations and must be complete.
• Evidence: Audit trail report showing integrity checks.

Deviations

Any deviations from the protocol must be documented and reported to the Quality Assurance department. Investigations must be conducted to determine the root cause, and corrective actions must be implemented as necessary.

Approvals

This protocol requires approval from the following individuals:

• Validation Manager: ______________________ Date: __________
• Quality Assurance Manager: ______________________ Date: __________
• Production Manager: ______________________ Date: __________