Category: CQV

North Carolina leads the southeastern United States in research and manufacturing in the pharmaceutical and biotechnology spaces. The state has key manufacturing sites spanning from the mountains to the coastal plain, and ranging from small molecule to complex biotechnologies. What started in the state as typical pharmaceutical production and processing, has developed into advanced biotechnology […]

In pharmaceutical and medical device manufacturing, the qualification of equipment and systems is a critical component of ensuring that they operate as intended, consistently producing high-quality products. The qualification process is divided into three key stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each stage plays a vital role in verifying that […]

Manufacturing drug products aseptically requires the utmost care to ensure that safe and effective products can make it to patients. It starts with the facility design and construction and is immediately followed by the manufacturing equipment selection, installation, and implementation.  When choosing the correct equipment and systems for manufacturing, process scientists, process engineers, microbiologists, and […]

Advanced Aseptic Processing starts with the facility: To assure safety and efficacy of the medicines many rely on, the manufacturers must embrace advanced aseptic processing. To the regular person, this might sound like a fancy buzz phrase but to those in the industry and those creating the powerful therapeutics that patients rely on, this is a […]

Automated Storage and Retrieval Systems (AS/RS) have revolutionized the landscape of material handling and storage, offering unprecedented efficiency and space optimization. However, the path to a seamlessly integrated AS/RS in a facility is fraught with challenges, especially during the validation phase. This critical stage is where theoretical designs and simulations confront the tangible realities of […]

In pharmaceutical and medical device manufacturing, the concepts of Commissioning, Qualification, and Validation (CQV) form the backbone of ensuring that equipment, systems, and processes operate as intended, consistently producing high-quality products. These activities are not just operational necessities; they are stringent regulatory requirements designed to safeguard patient safety. With a landscape governed by international standards […]

In the critical field of pharmaceutical manufacturing, where patient safety is paramount, the strength of our engineering teams is not just a matter of efficiency or productivity—it’s a matter of life and death. As leaders, our approach to building and nurturing these teams directly impacts the quality of our output and, ultimately, the safety of […]

In the fast-evolving world of pharmaceutical manufacturing, we stand at a crossroads where tradition meets innovation. As an industry, we are custodians of health, holding the safety of patients firmly in our hands. This immense responsibility, I believe, is shouldered not just by the meticulous processes we uphold but significantly by the manufacturing staff who […]

In the fast-paced world of pharmaceutical manufacturing, ensuring regulatory compliance and maintaining data integrity are crucial for success. That is why finding the right Commissioning, Qualification, and Validation (CQV) partner is essential. This blog explores the key factors that pharmaceutical manufacturers should consider when seeking a CQV provider to establish robust data governance practices.  Establishing […]