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Joanne S. Eglovitch

Senior Editor

Washington DC
Joanne Serpick Eglovitch is a senior editor for Pink 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.”

Latest From Joanne S. Eglovitch

US FDA Gives Wholesalers But Not Manufacturers More Time To Begin Verifying Saleable Returns

Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.

Manufacturing Quality

US FDA Investigators Focusing Inspections On Aseptic Processing Operations

US FDA investigators' increased focus on aseptic operations is resulting in more Form 483 observations of microbiological contamination issues over the past few years.

Manufacturing Quality

US FDA Launches Quality Maturity Pilots That Reward High-Performing OTC, Rx Manufacturers

One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”

US FDA Launches Quality Maturity Pilot Program

High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.

Manufacturing Quality

US FDA Launches Quality Maturity Pilot Program That Rewards High-Performing Manufacturers

High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.

United States Manufacturing

Rx-360 Issues Guide On Remote Supplier Audits; CEO Warns They May Take Longer At First

Manufacturers should expect that remote audits of suppliers may take longer than onsite ones until they get more familiar with these audits; it is also important to abide by data confidentiality rules and take frequent breaks when conducting these audits, says Rx-360 CEO.

Manufacturing Quality
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