Design Qualification Protocol for Temperature Controlled Warehouse

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the Temperature Controlled Warehouse is designed and constructed to meet the requirements for the storage of raw materials in a compliant manner, ensuring product quality and integrity.

Scope

This protocol applies to the Design Qualification of the Temperature Controlled Warehouse used for the storage of raw materials in the pharmaceutical manufacturing process.

Responsibilities

The following personnel are responsible for the execution and approval of this protocol:

• Validation Manager: Overall responsibility for the validation process.
• Quality Assurance: Review and approval of the DQ protocol and reports.
• Engineering: Implementation of design specifications and modifications.
• Warehouse Manager: Operational oversight of the warehouse.

Prerequisites

• Completion of User Requirements Specification (URS).
• Approval of project scope and budget.
• Completion of risk assessment for the facility design.

Equipment Description

The Temperature Controlled Warehouse is designed to maintain the required temperature and relative humidity (RH) levels for the safe storage of raw materials. It includes the following features:

• Temperature monitoring systems with alarms.
• Relative humidity mapping capabilities.
• Audit trail functionality for data integrity.

Test Plan

Detailed Test Cases

Test Case T1: Verify Temperature Mapping

Procedure: Conduct temperature mapping across the warehouse using calibrated sensors. Record the temperature at multiple points over a specified duration.

Acceptance Criteria: All recorded temperatures must remain within the specified range as per URS Annex 11 and Annex 15.

Evidence: Mapping report with temperature data.

Test Case T2: Check RH Mapping

Procedure: Conduct RH mapping using calibrated sensors. Record the RH levels at multiple points over a specified duration.

Acceptance Criteria: All recorded RH levels must remain within the specified range as per URS Annex 11 and Annex 15.

Evidence: Mapping report with RH data.

Test Case T3: Test Alarm Functionality

Procedure: Simulate conditions that exceed temperature and RH thresholds to test alarm activation.

Acceptance Criteria: Alarms must activate within set thresholds and notify the appropriate personnel.

Evidence: Alarm test log showing activation times and conditions.

Test Case T4: Audit Trail Verification

Procedure: Review the audit trail generated by the temperature and RH monitoring systems for completeness and accuracy.

Acceptance Criteria: The audit trail must show all changes and alarms with timestamps.

Evidence: Audit trail report.

Deviations

Any deviations from the acceptance criteria must be documented and justified. A corrective action plan must be developed to address any identified issues.

Approvals

By signing below, the following individuals approve this Design Qualification protocol:

• Validation Manager: ________________________
• Quality Assurance: ________________________
• Engineering: ________________________
• Warehouse Manager: ________________________