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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

Pharmaceutical Industry Not 'Reaping the Benefits' Of Quality Risk Management Tools, Expert Says

Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.

Manufacturing Quality

Industry Consortium Developing Best Practices For Meeting Proposed EU GMP PUPSIT Requirement

The pharmaceutical industry is grappling with the fact that, despite their concerns of additional risk, pre-use, post-sterilization integrity testing (PUPSIT) may remain an expectation in the EU's Annex 1. A consortium has been established to help companies address filtration related risks that PUPSIT is designed to mitigate and to develop a best practice guide on PUPSIT to help manufacturers comply with the EU's Annex 1.
Manufacturing Quality

US FDA Issues Guidance Outlining Process For Requesting DSCSA Waivers

Pharmaceutical manufacturers now have, at long last, guidance from FDA on the process for applying for exceptions and waivers under DSCSA. Yet they don't have much time to act as the new serialization requirements go into effect this November. Exception requests have to be submitted soon.
United States Manufacturing

FDA Allows Co-Located Outsourcing Facilities And Traditional Pharmacies

FDA has issued final guidance that allows outsourcing facilities to share the same physical address as traditional pharmacies as long as their operations are completely segregated. Draft guidance forbidding such co-location drew opposition.

United States Manufacturing

Manufacturing Compliance Updates In Brief From US FDA And EU

Many of the six drug GMP warning letters the US FDA has issued since late March targeted lax testing practices, particularly at OTC firms abroad. Two EU GMP non-compliance notices highlighted data integrity shortcomings in India. FDA also posted a couple of Form 483 reports and added four facilities to its GMP import alert.

Europe United States

EMA Takes Flexible Approach In Setting Exposure Limits for Drugs Produced In Shared Facilities

The European Medicines Agency on April 30 issued an updated question and answer guidance that accords manufacturers more flexibility in meeting health-based exposure limits for drugs produced in shared facilities
Europe Manufacturing
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