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Joanne Eglovitch

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 Eglovitch

FDA Outlines How Generic Drug Makers Can Reverse Filing Decisions

ANDA sponsors can file a 'request for reconsideration' disputing regulatory decisions and can appeal some – but not all – of the agency's decisions. If manufacturers are still not happy with outcome, they can go through the formal dispute resolution process.

Generic Drugs Manufacturing

PDA Survey Shows Compliance Can Trump Science In Aseptic Processing

PDA leaders weigh in on results of recent aseptic practices survey, saying pharmaceutical manufacturers may be carrying out certain aseptic practices to meet the expectations of regulators rather than the dictates of science. The survey also shows that despite adoption of technologies like RABS and isolators to keep workers away from sterile drug products, half the time they're still the root cause of contamination.

Europe United States

FDA Revises Guidance on DMFs and Prior Approval Supplements to Reflect GDUFA II

FDA has revised references in guidance to generic drug user fee requirements that changed under GDUFA II on Oct. 1. One guidance document no longer says for generics firms to pay user fees for prior approval supplement reviews. Another gives review goals for drug master file completeness assessments.

Manufacturing Quality

Lilly Official Offers Tips On Reducing Contamination Risks In Cleanrooms

Having a multilayered approach to sterility assurance is key to preventing contamination in cleanrooms, with equal attention paid to gowning, aseptic technique, engineering technique and proactive and detailed trending, says Eli Lilly official. Official also advises manufacturers to follow both USP Chapter 1116 and the EU’s Annex 1 if they want their sterility assurance programs to pass muster with inspectors and do business globally.

Manufacturing Quality

EU Defends Plans To Keep 'PUPSIT' Testing In Revised EU GMP Annex 1

An EU regulatory official is undeterred by pleas from industry to modify a requirement that manufacturers conduct pre-use, post-sterilization integrity testing of filters for sterile drugs under EU GMP Annex 1. The original annex required PUPSIT testing and the revision also is expected to require it. The revised annex has been repeatedly delayed, and now is expected early next year.

Manufacturing Quality

FDA Clarifies Scope Of Its Emerging Technology Program

FDA has issued final guidance that clarifies the types of technologies eligible for acceptance into the agency's Emerging Technology Program. FDA also issues internal guidance to explain how reviewers should handle emerging technology applications.

Manufacturing Quality
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