02.25.25 -- These Were FDA's Top Citation Issues For Data Quality In 2024

Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

Discover the three essential elements that contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

Testing and selecting an aqueous cleaning system involves a seven-step process. In this chapter of The Aqueous Cleaning Handbook, we walk through those steps to help you optimize your cleaning process.

Drug manufacturers seeking alternative methods for a safe and reliable approach to drug delivery should consider blow-fill-seal technology. Learn about the benefits it offers over traditional glass packaging.

Major retailers are mandating X-ray inspections for their suppliers. Uncover why this technology is crucial, and its capabilities beyond contamination detection to encompass vital quality and integrity.

Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.

Don’t let the cost of poor quality hold your business back. Gain valuable insights into how a modern quality management system can transform your operations and drive success.

Find out how a strategic partnership with a used equipment dealer can provide guidance through the process of a merger or acquisition of manufacturing facilities and simplify equipment removal and sales.

A company needed to produce the registration batches of a generic broad-spectrum antibiotic. See how a CDMO with an experienced project management team helped meet the 4-month timeline.

Containment is growing in importance due to increasingly stringent legal requirements for packaging solid medicines. Learn in detail about containment solutions for the pharmaceutical industry.

To help manage impurities and mitigate risk across all stages of development, consider the benefits of working with a CDMO with robust chemistry understanding and manufacturing experience.

Understand why partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry to ensure product quality and compliance.

Begin your ADC manufacturing journey by finding a partner who can provide support through every phase of the conjugate life cycle, including process optimization, scale-up, and validation.

The rheological properties of powders are crucial in achieving uniform die filling during tablet production. Explore the results of a study evaluating the flow, cohesion, and compressibility of common excipients.