Analytics

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Select Suppliers with Demonstrated Expertise to Avoid Sourcing “Bad” APIs

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Locking Fraudulent Materials Out of the Supply Chain

Leveraging vast quantities of analytical data requires digitalization and platform integration. 

Paradigm Shift for Data Analysis and Interpretation

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

FDA Issues Warning Letter to Baxter’s Drug Manufacturing Plant Acquired in Claris Buy

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Flow imaging microscopy can be used to identify particulates and their sources.

Identifying Contamination: Subvisible Particle Imaging

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 1

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 2

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 3

Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.

Stability Testing Determines Proper Drug Storage Parameters

Fabia Gozzo, PhD, is CEO of Excelsus Structural Solutions, www.excelsusSS.com. With more than 25 years of experience at synchrotron facilities, she has constructed and developed a state-of-the-art powder diffractometer at the Swiss Light Source before founding Excelsus Structural Solutions, a spin-off company that provides synchrotron radiation based analytical services to the pharmaceutical and chemical industry.

X-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials. 

Finished Product Analysis