Why CQV is Essential for Oral Solid Dosage Manufacturing Commissioning, Qualification, and Validation (CQV) play a crucial role in Oral Solid Dosage (OSD) pharmaceutical manufacturing, ensuring that facilities, equipment, and processes meet strict regulatory and quality standards. Without a structured CQV approach, manufacturers risk product quality failures, regulatory non-compliance, and operational inefficiencies that can impact […]
An air barrier system is fundamental in modern building construction to control airflow between the interior and exterior environments. Properly designed, installed, and tested air barriers significantly enhance the energy efficiency, indoor air quality, and overall performance of a building. This blog post will articulate the best practices for air barrier systems within building envelopes, […]
Lyophilization is a cornerstone of pharmaceutical manufacturing, providing a reliable method to stabilize biologics, vaccines, and injectable drugs. For FDA-regulated facilities, ensuring that lyophilization systems are properly commissioned, qualified, and validated is essential—not only for compliance but also for maintaining product efficacy and stability. Inaccuracies or failures in these processes can result in contamination, product […]
Artificial Intelligence (AI) has emerged as a transformative force across industries, and pharmaceutical manufacturing is no exception. With its capacity to analyze vast datasets, streamline operations, and provide real-time insights, AI is driving efficiency and innovation. This blog explores the current applications of AI in pharmaceutical manufacturing and offers a glimpse into its promising future. […]
A validation career in pharmaceutical and medical devices involves ensuring that products meet the highest standards of quality, safety, and regulatory compliance. Validation professionals test and document processes, equipment, and systems to confirm they perform as intended. This field offers opportunities for collaboration, problem-solving, and contributing to the development of safe and effective healthcare products. […]
In today’s world, people spend a significant portion of their time indoors, the comfort and well-being of occupants has become a paramount consideration in building design and operation. Poor indoor air quality, inadequate temperature control, and other comfort-related issues can have a significant impact on occupant health, satisfaction, and even productivity. Fortunately, existing building commissioning […]
The Critical Role of TMV in Medical Device Validation Test Method Validation (TMV) is a fundamental requirement in the medical device industry, ensuring that testing processes deliver accurate, repeatable, and reliable results. Without validated test methods, manufacturers risk inaccurate measurements, regulatory non-compliance, and compromised product quality—all of which directly impact patient safety. TMV is not […]
When it comes to pharmaceutical manufacturing, precision and adherence to regulations are paramount. Among the many processes critical to ensuring product safety and compliance, sterile preparation (sterile prep) stands out as a fundamental and indispensable step. But why is sterile prep so important, and how can pharmaceutical facilities maintain the highest standards of compliance? This […]
As the emphasis for sustainability and energy efficiency continues to expand, retrofitting building envelopes in existing buildings and structures has become increasingly more important.Retrofitting involves upgrading several different key components of a building’s exterior to improve the energy efficiency, indoor occupant comfort, and overall performance of the building. Today we will dive into the primary […]
Starting a new job is a big step. At Performance Validation (PV), we’ve built a training program with your success in mind, designed to help you grow professionally, gain valuable skills, and hit the ground running. Here’s a look at how we ensure our team members are equipped for success from their first day: 1. […]
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.