pharmaceuticals

3 Reasons Why VAWD Accreditation Matters

The health of American citizens relies largely on the quality of prescription drugs they take. Even though the United States takes every precaution to secure its medication supply chain, there are still certain issues that can arise. In order to combat the potential risks of an unsecured supply...

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Preparing For the Return of FDA Surveillance Inspections: A Guide for Pharmaceutical Manufacturers

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.   

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Pharmaceutical Validation: 6 Principles for Effective Implementation

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.

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5 Key Trends Impacting the Pharmaceutical Industry

The pharmaceutical industry is constantly evolving with new medications, changing regulations and pressure to reduce pricing. What’s next for the industry? Experts have identified five key trends emerging in 2019 that will significantly influence the way pharmaceuticals are manufactured and...

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USP <795> and <797> Revisions: What Compounders Should Know

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 safety,...

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The Biggest Pain Points in Pharmaceuticals and How to Treat Them

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 predicted...

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Fully Understanding the Drug Supply Chain Security Act (DSCSA)

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 milestone...

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Critical Conditions: Guidelines for Handling and Storing Hazardous Drugs

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.

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The Major Pharmaceuticals Losing Patent Protection in 2016

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

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FDA Temperature Mapping and Monitoring Explained: A Dickson Translation

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

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