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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’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers

US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.

Manufacturing Quality

Risk Assessments Of New Drug Elemental Impurities Get Mixed Reviews From Regulators

ICH Q3D went into effect in June 2016 for new drugs, but so far doesn't seem to have completely resolved worries about the presence of elemental impurities in drug products.

Manufacturing Quality

Why Industry Wants ICH To Harmonize Process Validation Guidance

After a proposal for harmonized process validation guidance didn't make the cut at ICH, PhRMA and US FDA proponents are making the case to a broader audience. Current ICH guidance is unclear, and regional guidance is conflicting, they told the ISPE annual meeting.

Manufacturing Quality

Manufacturers Should Generate Own Elemental Impurity Data To Comply With ICH Q3D

Manufacturers should create internal databases on elemental impurities for product risk assessments and not depend on suppliers to provide this information, which is called for under ICH Q3D. So far risk assessments have shown that most products are significantly below elemental impurity thresholds. Pharmaceutical manufacturers must complete assessments of legacy drugs by Dec. 31.

United States Europe

USP Mulls Rapid Sterility Testing Standards For Cell Therapies, PET Drugs And Sterile Compounding

USP is looking to develop standards for rapid sterility tests for drugs and biologics. Existing growth-based compendial methods are too slow to obtain results before cell and gene therapies, positron emission tomography drugs and sterile compounded drugs must be used. Quicker methods would improve efficiency in the manufacture of other drugs as well. Detection limits could be orders of magnitude higher without compromising the ability to detect infectious levels of microbiological organisms.

Manufacturing Quality

How To Find And Remedy Data Integrity Lapses In Microbiology Labs

Analytical chemistry labs may get all the attention when it comes to the search for data integrity failures, but FDA and industry experts say not to overlook the possibility of such failures in microbiology labs. Just keep in mind that the highly manual operations in these labs calls for a different approach to auditing.

Compliance Manufacturing
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