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Joanne S. Eglovitch

Senior Editor

Washington DC
Joanne Serpick Eglovitch is a senior editor for “The Gold Sheet” where she writes about manufacturing quality issues. Joanne has over 20 years of experience covering the regulated pharmaceutical and medical device industries, and helped launch the “International Pharmaceutical Regulatory Monitor” and the “International Medical Device Regulatory Monitor”. Previously Joanne covered the mortgage finance industry and the mortgage capital markets, and employment and training programs. Before her forays into newsletter journalism, Joanne worked as a general assignment reporter for a twice-weekly newspaper in southern Maryland and an editorial assistant for “Insight” Magazine, published by “The Washington Times.”
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Latest From Joanne S. Eglovitch

Not All GDUFA II Facility Deficiencies Require Major Amendments, FDA Decrees

Final guidance clarifies US FDA’s position on what is considered a major amendment subject to longer reviews, and what is considered a minor amendment subject to shorter reviews under GDUFA II.

Manufacturing Quality

Industry API Guidance Says How To Ensure Starting Materials Are GMP Compliant

Guidance from a  European chemical industry group's API committee could help pharmaceutical manufacturers ensure that suppliers are applying GMP controls early enough in the active pharmaceutical ingredient manufacturing process, industry official tells ISPE meeting. While ICH Q7 guidance explains what to do when applying GMPs to APIs, the committee's document fills in some of the details on how to do it.

Manufacturing Quality

Manufacturing Compliance Updates In Brief From US FDA And EU

Data integrity problems reemerged as a theme in seven recent drug GMP warning letters the US FDA sent to drug and active ingredient manufacturers at sites in South Korea, Australia, Taiwan, China, Ireland and France. Investigators also are seeing problems with inadequate testing of components and inattention to investigating batch failure. FDA issued a Form 483 report to Glenmark in India for inadequate cross-contamination controls, in the EU, the Spanish Agency of Medicines and Medical Devices withdrew one Spanish drug maker’s GMP certificate for multiple GMP violations.
Quality Compliance

FDA Resumes Quality Metrics Effort With Feedback And Site Visit Initiatives

FDA’s quality metrics initiative emerges from hibernation with a two-part feedback program and a site visit program. The agency plans to collect feedback on quality metrics in certain meetings conducted during the application process – and in a pilot program. Agency staff also plan to visit firms to learn how they use quality metrics.

Manufacturing Quality

As Continuous Manufacturing Approaches 'Tipping Point,' Successful Applicants Share Tips

The pharmaceutical industry may be approaching a "tipping point" with applications for continuous manufacturing, and successful applicants share secrets to the success they have achieved with FDA and other regulatory authorities around the world.
Manufacturing Quality

FDA Lauds St. Gallen's Findings On 10 Metrics For Ensuring Drug Quality

US FDA touts new evidence that high performance of pharmaceutical manufacturing sites on 10 quality maturity metrics correlates with robust pharmaceutical quality systems, operational excellence and good business. An FDA-funded study by St. Gallen also finds that low performance, on the other hand, correlates with manufacturing problems.

United States Manufacturing
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