Pharmaceutical Manufacturer – Commissioning & Qualification


Overview

A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with commissioning and qualification of a fleet of innovative mobile research units for use in clinical trial research to meet an accelerated schedule. The mobile research units provided several functions critical to conduct life-saving clinical trials by enabling ‘pop-up’ research centers to connect with high-risk patients in locations with high infection rates. Additionally, using these units, researchers were able to access trial participants who would not normally be capable of visiting traditional clinical trial research centers due to health risks and mobility issues.

The several functions provided by these units included: being a mobile command center for clinical trial staff, allowing storage and rapid transportation of drug product to participants, providing transportation of clinical trial supplies, allowing blinded randomized administration of the investigational product, and providing temporary storage of participant samples before being sent to analytical laboratories. A remote monitoring system was installed within each of the research units to provide temperature monitoring of the product, preparation area, critical equipment, and trial participant samples to ensure that the participants were treated with unaltered drugs and the trial results maintained accuracy. The monitoring system installed within each of the research units was capable of communicating and storing data at the main research center to allow for maintenance of accurate, real-time records to support expedited regulatory approval.

The Solution

Performance Validation (PV) provided validation resources to aid in the identification of the critical aspects and requirements of the research units to meet regulatory requirements, development of testing for the equipment with a streamlined process, and provide validation lifecycle documentation.

Qualification Plan

Developed a plan for the commissioning & qualification documents to maximize the benefits of the ASTM E2500 methodology to minimize project timeline

User Requirements

Worked with internal engineers, quality, and clinical trial personnel to determine critical user requirements to meet both internal, product-specific, and regulatory requirements

Design Review

Performed design review for the equipment to be installed within the mobile research units as well as the monitoring systems to ensure the system was capable of reporting and storing critical information.

Commissioning, Qualification, and Verification

Developed and executed verification testing for critical equipment including temperature mapping of multiple refrigerators and plasma freezers. Performed computer system validation of the remote monitoring system.

Supporting Lifecycle Documentation

Developed several validation documents to provide support through the Lifecycle of the system including system overview and configuration, security plan, maintenance strategy, components classification, and traceability matrix

Project Management

Provided leadership and communication throughout the project, helping the project team to identify and avoid potential project hurdles as well as troubleshoot any problems that arose

The Results

The fleet of mobile research units with all the critical equipment was qualified and immediately released for research use in remote areas. This enabled the company to quickly conduct Phase I, II, and III clinical trials allowing for expedited treatment of patients. The development of these units has enabled several other clinical trials to begin the exploration of alternative means to reach more trial participants.

The Benefits

  1. The company was able to complete clinical trials with participants who were inaccessible to conventional clinical trial methods
  2. The mobile research units were available for use at the desired time to support the different company product clinical trial milestones
  3. Potential problems were identified during the design process and manufacturing errors were identified early in the assembly process and corrected which resulted in meeting project milestones ahead of schedule
  4. High quality and consistent documentation was generated to support the equipment throughout its Lifecycle