Why turnaround time is one of the clearest indicators of GMP lab performance

Q. What differentiates a high-performing GMP laboratory?

In addition to providing a broad range of analytical capabilities, including the latest technology and innovations, a high-performing centralized GMP laboratory is differentiated by the operating model behind those services.

When evaluating a laboratory partner, I encourage clients to look at the total value rather than analytical testing cost alone. Factors such as turnaround time or cycle time performance, continuous improvement, project management, staffing flexibility and scientific expertise can have a significant impact on development timelines, operational risk and overall program success.

At PPD Laboratory services, our operating philosophy emphasizes continuous optimization of laboratory performance. This enables us to deliver faster turnaround times while reducing downstream operational risk for our clients.

Q. Why is continuous improvement so important in GMP lab services?

For our clients, cycle time improvements translate into accelerated product release, reduced supply chain risk, greater inventory flexibility, stronger support for commercial scale-up and faster responses to regulatory agencies.

Our company’s Practical Process Improvement (PPI) Business System gives us a structured way to identify opportunities, eliminate waste and continuously improve laboratory performance while maintaining quality and compliance.

Q: How does continuous improvement enable you to respond to changing client demand?

Demand rarely follows forecasts exactly. Product launches, manufacturing changes, quality events and supply chain disruptions can quickly increase analytical testing requirements.

Because continuous improvement is embedded in how we function every day, we build flexibility into our laboratory operations before changes in demand occur. Through daily operational reviews, forecasting and sales operations planning, we maintain visibility into changing needs and can quickly adjust staffing, optimize instrument utilization and scale resources within and across our laboratories.  

Cross-training, specialized resource management and personalized scientist training further enable us to respond rapidly to urgent testing needs while maintaining quality and compliance, as well as reducing cycle times.

For clients, this flexibility means minimized supply disruptions, on-track product release schedules, greater ability to manage unexpected demand spikes, preserved commercial continuity and quicker responses to global filing requirements.

Q. You mentioned turnaround times earlier. Why is that an important performance metric?

I view turnaround time as one of the clearest indicators of laboratory performance because it offers a broader view of how effectively the lab is operating. Consistent turnaround performance shows how well scientific, quality, and operational teams work together, while turnaround time also reflects how quickly testing is completed. Both speed and consistency matter equally.

Speed creates value when it is delivered consistently and supported by rigorous quality and compliance standards. Cycle time also captures the impact of quality events, such as deviations, out-of-specification investigations, and repeat analyses.

Q. How are cycle time expectations managed with clients?

Expectations are established during project planning and managed throughout the project using agreed-upon key performance indicators (KPIs). From there, our project and resource managers use our LIMS (laboratory information management system) platform to schedule work, allocate qualified resources, track samples and oversee study execution from start to finish.

That end-to-end visibility allows us to communicate proactively with clients throughout the project lifecycle, providing clear updates on progress, potential risks and performance against agreed-upon KPIs.

Q. How can reduced cycle time help get products to market faster?

Analytical testing is often a critical component of the overall supply chain. Before products can be released for distribution or reach patients, they must complete GMP analytical testing and quality review. Reducing laboratory cycle time can therefore significantly accelerate commercial availability.

For products with a short or limited shelf life, every day saved during analytical testing increases the amount of usable product available for patients and reduces the risk of inventory obsolescence.

One example to illustrate this point is an inhaled drug product where continuous improvement efforts enabled our GMP laboratory to achieve a 45-day turnaround time for required release testing. That significantly reduced the analytical portion of the supply chain and allowed the product to reach the market approximately two and a half months earlier.

The impact extends beyond commercial manufacturing. During development and regulatory submissions, rapid analytical support can keep programs on schedule and enable sponsors to respond more quickly to regulatory questions.

Q. Is cycle time more important for certain types of products than others?

Cycle time is important for all products, but has an especially significant impact for complex biologics, where analytical testing is often on the critical path to development, regulatory approval and product release. This includes cell and gene therapies, autologous and allogeneic therapies, monoclonal antibodies, antibody-drug conjugates, and biosimilars.

For autologous therapies in particular, time is critical because manufacturing and testing are directly linked to an individual patient’s treatment. Every day saved in analytical testing can accelerate treatment for an individual patient.

Biosimilars present a different but equally compelling challenge. Once originator patents expire, multiple developers often compete to be among the first to market, making speed a significant competitive advantage. Regulatory review can also generate requests for additional analytical work, including new method development, validation, specification updates or additional stability studies.

Q. What solutions can you provide in a scenario where speed is a top priority?

Our scientists work directly with clients to collaboratively solve analytical challenges, respond to regulatory requests and adjust testing strategies as development programs evolve.

We have options to build custom digital workflows that streamline sample intake and reporting, helping clients move from sample receipt to decision even faster. Together, those capabilities help clients respond quickly to regulatory questions and keep programs moving forward, which is especially critical when speed is a top priority.

This collaborative approach strengthens the likelihood of first-cycle regulatory approval and supports faster product launches in highly competitive markets.

Q. What should customers prioritize when selecting a GMP lab partner?

The right partner should accelerate development, reduce operational risk and strengthen supply chain resilience. Organizations should look for demonstrated scientific expertise, a strong quality culture, predictable cycle time performance, operational flexibility and a commitment to continuous improvement. These capabilities influence far more than laboratory testing; they affect regulatory timelines, commercial readiness, inventory management and ultimately business success.

Our goal at PPD Laboratory services is to build long-term partnerships, not simply perform analytical testing. We want our laboratories to become an extension of our clients’ organizations—bringing the scientific expertise, operational rigor and the responsiveness needed to bring therapies to patients faster.