Document ID: DQ-001

Version: 1.0

Effective Date: 2023-10-01

Review Date: 2024-10-01

Design Qualification Protocol for Aseptic Filling Machine in NDDS Production

Tags: Equipment Validation, Aseptic Filling, NDDS, Liposomes, Lipid Nanoparticles

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the Aseptic Filling Machine meets the specified requirements for the aseptic filling of NDDS products, specifically liposomes and lipid nanoparticles, in compliance with applicable regulatory standards.

Scope

This protocol applies to the validation of the Aseptic Filling Machine used in the production area for the aseptic filling of NDDS products. It encompasses the design, installation, and operational qualifications necessary to ensure compliance with regulatory standards.

Responsibilities

Validation Team: Responsible for the execution and documentation of the DQ protocol.
Quality Assurance: Responsible for reviewing and approving the DQ protocol and its outcomes.
Production Team: Responsible for the operation of the Aseptic Filling Machine and adherence to SOPs.

Prerequisites

Completion of User Requirement Specification (URS).
Installation of the Aseptic Filling Machine in compliance with manufacturer specifications.
Training of personnel on the operation of the Aseptic Filling Machine.

Equipment Description

The Aseptic Filling Machine is designed for the aseptic filling of NDDS products into vials, pre-filled syringes (PFS), and cartridges. It incorporates features for fill accuracy, aseptic controls, reject logic, and audit trail capabilities.

Test Plan

Test ID	Procedure	Acceptance Criteria	Evidence
T1	Verify fill accuracy	Fill accuracy within ±5% of target volume	Calibration records, test results
T2	Assess aseptic controls	No contamination detected	Microbial test results
T3	Evaluate reject logic	System rejects non-conforming units	System logs, test results
T4	Check audit trail	Complete and accurate audit trail	Audit trail report

Detailed Test Cases

Test Case T1: Verify Fill Accuracy

Procedure: Fill a series of vials with a predetermined volume and measure the actual fill volume.

Acceptance Criteria: Fill accuracy must be within ±5% of the target volume.

Evidence: Documented measurements and calibration records.

Test Case T2: Assess Aseptic Controls

Procedure: Conduct microbial testing on filled vials.

Acceptance Criteria: No contamination detected in samples.

Evidence: Microbial test results documentation.

Test Case T3: Evaluate Reject Logic

Procedure: Simulate a non-conforming unit and verify that the system rejects it.

Acceptance Criteria: The system must successfully reject the non-conforming unit.

Evidence: System logs and test results documentation.

Test Case T4: Check Audit Trail

Procedure: Review the audit trail generated by the Aseptic Filling Machine.

Acceptance Criteria: The audit trail must be complete and accurate.

Evidence: Audit trail report documentation.

Deviations

Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be established if necessary.

Approvals

Approved by: ______________________

Date: ______________________

Title: ______________________

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