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 […]
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 […]
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 […]
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 […]
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 […]
In the ever-evolving pharmaceutical manufacturing landscape, innovation is key to maintaining efficiency, safety, and compliance. One such innovation that has gained significant traction in recent years is the adoption of single-use technology (SUT). However, the successful implementation of single-use systems requires a thorough understanding of their unique characteristics and careful evaluation of their compatibility with […]
In pharmaceutical manufacturing, ensuring quality is not a matter of chance—it’s built into the process from the ground up. This is the core principle of Quality by Design (QbD), a systematic, proactive approach that focuses on integrating quality into the design and development stages of drug products. The QbD process begins with a clear target: […]
Drug delivery has always been a challenge in the development of new treatments, but what has truly transformed the landscape is how these challenges are being addressed with cutting-edge materials. This evolution in materials technology has significantly impacted both pharmaceuticals and medical devices. In the early days of solid oral dose (OSD) products, advanced materials […]
In the fast-paced world of pharmaceutical manufacturing, the need for efficient, reliable, and compliant systems is paramount. Traditionally, Stainless Steel Technology (SST) has been the cornerstone for ensuring product quality and maintaining sterility, requiring extensive cleaning, sterilization, and validation procedures. However, Single Use Technology (SUT) has emerged as a viable alternative that offers significant improvements […]
Summary: North Carolina is a hub for pharmaceutical and biotechnology companies, driven by a skilled workforce that keeps the industry thriving. This blog explores the key strategies for attracting, training, and retaining top talent in the competitive pharma manufacturing sector, emphasizing the crucial role of education and continuous skill development. North Carolina has established itself […]
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.
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