A CQV Checklist for Gene Therapy Facilities

A CQV Checklist for Gene Therapy Facilities

As more cell and gene therapies receive approval, the commercial demand for these groundbreaking medical treatments will increase rapidly.


The commissioning, qualification, and validation (CQV) activities at a gene therapy facility present unique challenges that are specific to the production of these novel therapies.

There are several steps that biopharmaceutical companies should take to keep greenfield and brownfield gene therapy facility projects ahead of schedule and under budget.

  • 1. Process Equipment and Design

    The equipment used in the manufacturing process for gene therapies is a highly important component that requires much planning. Does your equipment meet your process requirements and what is the lead time for procurement? If you use the equipment for automated processes, you should have fail-safes built into the design of the hardware and software. Seek a partner that can help you through the early basis of design stages to ensure you meet manufacturing timing and requirements as well as achieve regulatory compliance.

  • 2. Vendor Audits

    Establish a single point of contact to avoid miscommunication when it comes time to conduct a vendor site audit for data integrity and security. Your vendor’s quality system needs to be rigorous, and their data security needs to pass your audit with flying colors and meet the FDA’s requirements for Computer System Validation (CSV) guidelines and 21 CFR Part 11.

  • 3. Procurement Timelines

    Production of gene therapies requires the procurement of singleuse technologies (SUT) that can meet requirements for sterility, stability, physical integrity, and strength. Still, it can be challenging to find a reliable supplier. It’s crucial to align the procurement of specialized equipment around timelines for construction, utility installation, and the facility plan. Allow for additional time to find a supplier for customized manufacturing equipment.

  • 4. Follow ISPE GAMP 5 Guidelines

    Focus on computer system validation in the areas with the highest risk and impact on your manufacturing processes. Work with a CQV expert that can demonstrate an efficient use of ISPE GAMP 5 guidelines to stay within important business and regulatory areas while eliminating redundant testing during the CQV activities at your gene therapy facility.

  • 5. Apply Custom Off-the-Shelf (COTS) Applications

    The use of custom off-the-shelf (COTS) solutions, especially for gene therapies, has significantly increased over the last decade. Innovative COTS qualification strategies can produce significant cost savings and help you reach your capital project milestones months ahead of schedule.

  • 6. Invest in Isolators

    Your production process needs to be protected from contamination by pathogenic microorganisms, and isolators offer a closed area where the manufacturing process happens in an HVAC cleanroom. The right custom isolator setup can reduce the use of protective safety suits, airlocks, and energy.

  • 7. Use a Flexible Approach

    Facilities for the production of gene therapies are still evolving, and there is no one-size-fits-all method for designing them. It’s essential to have a flexible approach that can accommodate your facility’s future needs, which will reduce downtime when expansions or changes arise.

The CQV Plan for the Future of Gene Therapy


Find an experienced CQV partner with a proven grasp on the constantly changing gene therapy manufacturing field. Together, you can develop a plan to eliminate costly mistakes, maximize utilization of critical materials, and prepare for the production of future treatments.

A Pragmatic Approach to Biopharma Commissioning, Qualification, and Validation

A Pragmatic Approach to Biopharma Commissioning, Qualification, and Validation

Biopharmaceutical commissioning, qualification, and validation (CQV) activities are a high-impact, high-reward endeavor, with mission-critical schedules and budgets on the line.

For quality teams looking to hire expert CQV resources, the high stakes make for a difficult and complex decision.

Initial vetting of CQV vendors will leave you with a few qualified partners from which to choose, but it’s the next phase of consideration that will set your facility on the path to manufacturing readiness ahead of schedule and under budget. Look for a partner with a proven track record of proactive delivery in these three critical areas.

3 Hallmarks of Pragmatic CQV Delivery


  • 1. Streamlined Schedules

    Your CQV vendor should take full accountability of your budget and schedule and look for opportunities to cut costs and time while maintaining compliance. An integrated plan that conducts CQV initiatives in parallel with other construction activities will streamline your schedule and can reduce the number of resources required to complete the project.

    As an internal quality manager, you don’t have time to track down documentation and keep tabs on the minute details of the project. Ask your prospective CQV vendor about their documentation processes and how they keep clients updated on progress. Finding a CQV partner that can seamlessly become an extension of your team can knock months off of your schedule and lead to major cost savings.

  • 2. Comprehensive Project Controls

    A proactive, hands-on approach to CQV project controls will help you discover and prevent potential issues before they have a negative impact on your project. With a CQV partner that takes comprehensive accountability of your project, you can focus your attention on other critical internal initiatives.

    Look for CQV experts who have experience successfully conducting CQV projects in similar biopharma, biotech, or medical device facilities with a proven track record of knowing what works and what doesn’t. CQV partners that already know the latest procedures, regulations, and trends that apply to your industry and facility — including ISPE and PDA guidelines — can give you a jump start to quality while customizing their proven templates to your project.

    When considering potential vendors, be sure to seek a partner who can give you 24/7 access to a custom dashboard that tracks documentation, budgets, and all important project milestones.

  • 3. Proof of Minimized Execution Time and Cost

    Your project team should take pride in their ability to minimize execution time and lower costs. Ask for proof that they can:

    • Follow appropriate industry standards outlined by the FDA, EMA, ICH, WHO, ISPE, PDA, and ISO and apply them to your project to avoid regulatory slowdowns.
    • Plan for all direct impact and not direct impact systems needed and ensure the engineering designs are accurate and meet cGMP requirements.
    • Utilize a pragmatic CQV approach with proactive planning methods and apply it to their daily work, helping you complete the project ahead of schedule.
    • Rely on extensive biopharma validation experience to navigate continually changing regulatory requirements.
    • Routinely provide savings in overhead costs to help pay for a majority of the capital project.
    • Staff your team from a database of experts, allowing you to choose from accomplished construction managers, project managers, C&Q technical leads, C&Q consultants, C&Q engineers, documentation specialists, and more.
    • Lead you toward 100% right-first-time performance.

The CQV Process that Leads to Profitability


Search for a biopharma CQV partner that can prove their ability to streamline your schedule and use fewer resources with a proactive, customized, and transparent approach to project controls. Minimize execution timelines and costs with CQV experts who can get it done right the first time.