In pharmaceutical manufacturing, lyophilization plays a critical role in ensuring product stability, efficacy, and shelf life. However, the complexity of freeze-drying processes makes them highly sensitive to variations in temperature, vacuum levels, and environmental conditions. Without a robust risk assessment strategy, manufacturers expose themselves to significant operational, quality, and compliance risks. Implementing a risk-based approach […]
Read More
In Part 1 of our series, we explored what drew our long-tenured employees to Performance Validation (PV) and why they chose to stay. In Part 2, we continue their stories by highlighting how their careers have evolved over time. These journeys reflect not only personal growth, but also the opportunities and support that have shaped […]
Read MoreMaximizing return on investment (ROI) is a top priority for building owners, facility managers, and stakeholders, especially when it comes to optimizing performance and energy efficiency. One often overlooked yet highly effective strategy for achieving significant ROI is envelope testing. The building envelope is the physical barrier between the interior and exterior environments. By evaluating […]
Read More
The pharmaceutical landscape is evolving rapidly, and Pharma 4.0 is more than a buzzword, it is a transformative, strategic shift. Coined by the International Society of Pharmaceutical Engineers (ISPE), Pharma 4.0 extends the principles of Industry 4.0—automation, AI, IoT, and advanced analytics—into the highly regulated world of pharmaceutical manufacturing and quality systems. For manufacturers, distributors, […]
Read More
Completing a temperature mapping study is a big step toward compliance—but what you do with the results matters just as much. For 3PL providers serving the pharmaceutical and biotech industry, post-study action is where true operational value and regulatory assurance are demonstrated. Whether you are preparing for a client audit or striving to strengthen your […]
Read More
As a third-party logistics (3PL) provider serving the pharmaceutical and biotech industry, your facility plays a critical role in maintaining product safety and regulatory compliance. One of the most important ways to demonstrate your commitment to quality—and win client trust—is by conducting a temperature mapping study. Whether you are preparing for your first study or […]
Read More
At Performance Validation, we often talk about our commitment to integrity, collaboration, and problem-solving, but none of that would be possible without the steady foundation laid by our legacy employees. These are the people who have been with us for 10 years or more, shaping not only the work we do but how we do […]
Read MoreThe Leadership in Energy and Environmental Design (LEED) certification, is a globally recognized sustainable building practice standard, developed by the U.S. Green Building Council (USGBC). It is essential in new building construction for promoting environmental responsibility, enhancing energy efficiency, and improving overall building performance. A significant component of LEED certification is building commissioning, which ensures […]
Read MoreAs the pharmaceutical and life sciences industries continue to explore the benefits of artificial intelligence (AI), it is critical to apply the same rigor and structure to AI implementations as we would to any other computerized system operating in a GxP-regulated environment. While AI offers new efficiencies and insights, it also introduces new risks—particularly when […]
Read More
In FDA-regulated pharmaceutical manufacturing, the formulation and filling process plays a critical role in ensuring that each dose delivered to a patient is safe, effective, and consistent. Whether manufacturing sterile injectables, biologics, or other complex drug products, errors at this stage can carry severe regulatory, financial, and—most importantly—patient safety consequences. Why Formulation and Filling Matter […]
Read More
Skip to main content