Brian Svaton

Apr 9, 2024 | pharmaceuticalonline.com | Kate Coleman |Mike Ulman |Brian Svaton |Nikka Densok USA

There are important considerations that architects and engineers can miss if they don't include the quality perspective. It's better to involve quality at the outset rather than discover omissions when it's too late. Five Best Practices To Ensure Quality Active Pharmaceutical IngredientsIt is important to develop robust, reliable processes to safeguard APIs. Explore the best practices to provide patients with the highest quality treatment that meets their therapeutic requirements.

Dec 12, 2023 | pharmaceuticalonline.com | Peter H. Calcott |Brandon Cole |Brian Svaton |Nikka Densok USA

In October, the FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating its remote evaluations program, the logistics of its implementation, and what they expect of the industry. The public comment period ends on December 26.

Oct 6, 2023 | pharmaceuticalonline.com | Fran DeGrazio |Brian Svaton |Nikka Densok USA |Josh Russell

The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.