cGMP for your Clinical Batch | CDMO Insights

Why cGMPs matter to your clinical trial material Manufacturing best practices are critically important to clinical, operational, and financial success of your development program. In just the past five years, the FDA has issued more than 600 manufacturing citations. That’s more than 600 setbacks, 600 delays, 600 additional costs that have held back programs like yours. Current good manufacturing practices – cGMPs – are something to take seriously as soon as your product leaves the laboratory. In this video, Dr. Reuter explains what you need to know about cGMPs for your injectable drug product, how and where to start planning a cGMP-compliant clinical batch, and why you need to take the time to get these early process steps right. As Dr. Reuter notes, factoring these guidelines in early can help you save significant amounts of time and capital downstream. So what are cGMPs? They’re a continually evolving set of standards and regulations that help ensure the quality and safety standards of a product that will be used in humans. For an injectable medication, those regulations are particularly complex and stringent; the shift from preclinical to clinical development comes with a range of new procedural, logistic, and regulatory considerations. Since these guidelines are always evolving with the science, technologies, and products they pertain to, it’s important to have an expert partner like Vetter to help you understand, navigate, and compy with all relevant cGMPs for your molecule. -------------------------------------------------------------------------------------------------- Get more information on: Our website: https://www.vetter-pharma.com/en/serv... LinkedIn: https://www. linkedin.com/company/vetter-pharma or subscribe to our newsletter: https://www.vetter-pharma.com/en/news... -------------------------------------------------------------------------------------------------- Click here to subscribe to our YouTube channel:    / @vetterpharmaservices   -------------------------------------------------------------------------------------------------- Disclaimer: This motion picture, in whole or in part, including layouts, logos, software, text, illustrations, and graphics are protected by copyright law, with all rights reserved. This motion picture and its contents may not be reproduced, adapted, modified, transmitted, distributed or used without the prior and written consent of Vetter. The information contained in this motion picture is for general information purposes only. Vetter makes no representations, warranties, or assurances of any kind, neither expressed nor implied, about the completeness, accuracy, reliability, suitability, or availability with respect to this motion picture or the information, products, services, systems or related graphics contained within. Vetter Pharma International GmbH Eywiesenstr. 88212 Ravensburg Germany Vetter Pharma International USA Inc. 4901 Searle Parkway, Suite 300A Skokie, IL 60077 USA