Case Studies

Eurofins accepted a request to perform testing compliant with 21 CFR Parts 210/211 on an excipient material for over-the-counter pharmaceutical products and develop specific test methods to support the risk assessment of the manufacturing process and batch release. Read about what happened in response to the OOS test results.

The Food and Drug Administration (FDA) monitors drug manufacturers' compliance with its current Good Manufacturing Practice (cGMP) regulations in order to ensure the quality of drug products. These regulations are designed to assure products are safe for use and contain the ingredients, strengths, and efficacies of claims made by the product. Learn what tests your OTC products need to be compliant.

Foreign materials in products can be dangerous to consumers and damage a brand's reputation. At Eurofins, we have the expertise and experience to handle all kinds of foreign material investigations, including issues in pharmaceuticals and dietary supplements. This case study outlines how we used microscopy and elemental analysis to determine the cause of discoloration in a pharmaceutical tablet.

Natural and synthetic food dyes are used in almost all industries. Understanding the potential for dye adulteration is critical to knowing how and why products are affected. Furthermore, testing with a third-party lab can lead to standardized product coloration and reliable ingredient claims. This White Paper introduces the types of food dyes, the benefits of testing, types of tests, and considerations for choosing a third-party lab.

The botanical supplement and cosmetic industries are rapidly changing, and the increase in consumer demand calls for upscaling raw material sourcing. This means there is higher pressure for scientifically-valid contaminant testing, including screens for pesticides and heavy metals, while maintaining a fast turn-around time. Watch this webinar to learn modern approaches to contaminant detection, with an emphasis on market trends, broad dietary supplement applications, and OTC cosmetics.

Both Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) can apply to testing needed for your raw materials and products. Learn how they apply during different phases of the product development process.