Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA
Full Text Here
This guidance is intended to assist manufacturers in responding to the issuance of the United States Pharmacopeia (USP) requirement2 for the control of residual solvents in drug products marketed in the United States. Specifically, this guidance makes recommendations on the following:
1. How new drug application (NDA) and abbreviated new drug application (ANDA) applicants for noncompendial drug products should limit residual solvents as described in the International Conference on Harmonisation (ICH) guidance for industry Q3C Impurities: Residual Solvents (Q3C). This guidance contains recommendations on solvent classification and permitted daily exposure.3
2. How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with USP General Chapter <467> “Residual Solvents” and the Federal Food, Drug, and Cosmetic Act (the Act).
3. How holders of NDAs or ANDAs for compendial drug products should report changes in chemistry, manufacturing, and controls specifications to FDA to comply with General Chapter <467> and 21 CFR 314.70.
For recommendations on solvent classification and permitted daily exposure, please refer to the ICH Q3C.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.
As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.
Turn your Business Into an Investor Magnet
How to Write a Business Plan – Free E-Course
Get the secrets that turns your project into an investment magnet, 100% of our clients raise the finance they need to take their projects to the next stage, we will share these secrets with you. – Sign up for Free
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
