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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

Manufacturers Want Delay In Conducting US Nitrosamine Risk Assessments

Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.

Manufacturing Quality

COVID-19 Prompts WHO To Propose Revisions To GMPs For Investigational Drugs Guideline

Accelerated development of COVID-19 products prompts World Health Organization to revise a guideline on good manufacturing practices for investigational drugs and propose a new guideline applying GMP principles to R&D facilities.

Manufacturing Quality

Consortium Grows As Drugmakers Share Excipient Metal Impurities Data To Ease ICH Q3D Testing Burden

More manufacturers are contributing their analytical data to an excipient database to pool knowledge on the risk posed by excipients that may cause drugs to exceed acceptable PDE levels under ICH Q3D.

Manufacturing Quality

Regulators Find Room For ICH Q3D Metal Impurity Risk Assessments To Improve

The pharmaceutical industry is doing a better job of conducting the risk assessments called for in the ICH Q3D elemental impurity limits guideline, and regulators are not rejecting applications because of poor quality assessments, yet regulators say there is still room for improvement.

Manufacturing Quality

Final Revisions Should Ease Global Use Of EU GMP Annex I Sterile Drugs Guidance, Associations Say

Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.

Manufacturing Quality

The FDA Sticks With Plan To Exercise Discretion In Enforcing Physician Compounding

Physicians who compound drugs in their offices for patients will not be inspected as FDA decides to exercise discretion, recent final guidance said.

Manufacturing Quality
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