Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|August 14, 2008
FDA Releases Draft Guidance on Residual Solvents
Author(s)Pharmaceutical Technology Editors
The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.
Advertisement
Rockville, MD (Aug. 5)-The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.
The guidance is meant to assist companies holding new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for compendial products to comply with the testing requirements in the new USP General Chapter 467, which became official on July 1, 2008 (see related story, "
According to the draft guidance, among its recommendations, FDA “will require that US marketed drug products with an official USP monograph (compendial drug products) meet the residual solvents requirements in the new USP General Chapter <467>,” which provides options other than finished drug testing to evaluate compliance. The draft guidance also describes the conditions under which analytical procedures other than those described in USP <467> will be accepted.
See the
Advertisement
Related to this article
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Advertisement
Advertisement