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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

Manufacturers' Data Integrity Problems Remain FDA Investigators' Focus

US FDA official warns the pharmaceutical industry that investigators will continue to look for data integrity problems during inspections, and discusses “red flags” observed in inspections.

Manufacturing Quality

FDA Advisory Committee Votes Against Compounding Of Coated Modified Release Drugs

FDA’s Pharmacy Compounding Advisory Committee votes to place coated modified release drugs on the “difficult-to-compound” list, thus barring these drugs from being compounded in the foreseeable future. The committee agreed with FDA’s recommendations that the complex formulation and the difficulty in manufacturing them precludes them from being compounded at the current time.

Manufacturing Quality

Industry Needs To Be Aware of Serialization Challenges Under DSCSA

US pharmaceutical industry is warned that products “will not flow through the supply chain if the digital data is not right” under DSCSA, says official. Law’s second phase, which takes effect in November, mandates first-ever digital serialization requirements to ward off drug counterfeiting.

Manufacturing Quality

Pharma Industry Still Not At 'Tipping Point' In Adopting Continuous Manufacturing

Regulators and industry officials agree that despite efforts to spur development of continuous manufacturing, uptake has been slow globally. FDA still is on learning curve and acknowledges a knowledge gap around some of the higher order principles associated with continuous manufacturing.

Manufacturing Quality

Global Efforts Intensify In Fight Against Counterfeit Drugs

Regulators and manufacturers worldwide intensify cracking down on the scourge of counterfeit drugs, with APEC launching a toolkit, industry recruiting participants for a shared audit program and WHO warning that the problem is not going away anytime soon. While anti-malarials and -infectives and vaccines continue as prime targets, a new trend is emerging in “well-regulated’ markets of high-priced hepatitis drugs falsified.

Manufacturing Quality

‘Critical’ Issues Need Resolution Before ICH Q12 Proceeds To Next Step

Industry and regulatory working group participants are grappling with established conditions and post-approval change management protocols in developing early ICH Q12 draft guidance. Latest proposal calls for three post-approval change categories.

Manufacturing Quality
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