pharmaceuticals

In July, acting FDA commissioner Janet Woodcock announced that the FDA would be resuming non-mission-critical facility inspections, effective immediately. In this article, we’re going to discuss what that means for pharmaceutical companies, and how they can prepare for a successful audit.   

In good manufacturing practice (GMP) and other GxP’s, the term validation has a formal, specific meaning. In this context, validation is a quality management tool used to confirm that a process or a piece of equipment satisfies its intended purpose through the use of objective data.

The United States Pharmacopeial Convention, or USP, is a nonprofit science-driven organization that establishes standards for medicines. These standards are developed with independent experts and are primarily published in a compendium of General Chapters. While USP deals with quality and...

The pharmaceutical market is one of the fastest growing industries in the world today with numbers continuing to climb in 2019. The United States and Europe dominate the industry with the U.S. accounting for around a third of the global market. Drug prices in the United States alone are...

One of the biggest challenges pharmaceutical companies face is keeping up with changing regulations by state and federal organizations. This can be confusing as some agency rulings are established with specific milestones that can span several years, and the requirements for meeting each...

According to the Centers for Disease Control and Prevention (CDC), close to 8 million healthcare employees in the U.S. alone are potentially exposed to hazardous drugs every year.

Click here to see our updated infographic on the pharmaceuticals losing patent protection in 2017.

When it comes to regulatory bodies and concrete descriptions of how exactly you should be monitoring your environment . . . well it never comes to that.

The ISPE describes itself on its website: www.ispe.org, as ”the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.”