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The agency published a guideline for the implementation of ICH Q3D.

EDQM Publishes Elemental Impurities Guideline

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

FDA Releases Draft Elemental Impurities Guidance

ICPMS-2030 Expanding solutions for elemental impurity analysis in pharmaceutical products

The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

Meeting USP Guidelines for Elemental Impurity Analysis with X-ray Fluorescence Spectrometry

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

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

Going Small to Achieve Commercial-Scale Success

FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.

Chinese API Manufacturer Zhejiang Hisun Receives Warning Letter

FDA publishes the final Q3D Elemental Impurities guidance.

FDA Issues Final Elemental Impurities Guidance

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Katherine Ulman is a Global Regulatory Compliance Manager at Dow Corning.

Phyllis Walsh is a senior compendial manager at Schering-Plough Corporation in Kenilworth, New Jersey.

EHS specialist at Dow Corning Corporation, Auburn, MI

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Establishing Limits for Dermal Absorption of Elemental Impurities

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.

API Sourcing, Supply Chain Visibility, and Emerging Markets

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

Drug Substance Analysis