QbD Validation Strategies: The Process Design Phase 1 By Anil Doshi, R.Ph., Ph.D, President, Infinity Pharmaceutical Consulting
Process design is achieved through well-defined and established internal processes that are based on Quality by Design (QbD) guidelines. While QbD is not a mandated FDA requirement, it is recommended to implement a systematic process to evaluate and understand formulation and manufacturing processes using prior knowledge, experimentation, and risk assessment. The following describes the key action elements to process design.
INTERPHEX is the leading annual pharmaceutical and biopharmaceutical trade show, taking place in New York City on April 23 to 25, 2013. Key decision makers will find the networking opportunities, products, services, and information they need to ensure quality and to maximize the efficiency, agility, and flexibility that solve manufacturing and supply chain problems. INTERPHEX is where intelligence and passion intersect with the full spectrum of industry products and services to create new insights and innovation. Learn more.
Collecting Human Plasma To Save And Improve Lives ZLB Plasma Services, one of the largest collectors of human plasma in the world, is dedicated to the collection of plasma for life-saving therapies. The company is part of ZLB Behring group that is owned by CSL Limited, based in Australia.
Streamlining Particle Count Data Management Pharmaceutical cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt in order to remain both competitive and compliant with U.S. Food and Drug Administration (FDA) regulations.
Healthcare Supply Chain Requires Regulatory Expertise And Execution In the U.S. healthcare supply chain, before a medical device or drug can be shipped, state and county licenses must be secured, FDA Quality Systems regulations must be complied with, and accreditations must be earned. The healthcare supply chain plays a key role in patient safety by ensuring the integrity of products from the time they are manufactured to the time they are delivered to a healthcare provider or patient.