Quality/GMPs

Articles

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate. 

Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel. 

The Difference between Electronic Records Retention and Archiving

 Washington Editor, jillwechsler7@gmail.com.

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

FDA Advances Quality Initiatives to Combat Drug Shortages 

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

EMA Adopts List of Critical COVID-19 Medicines

Marwan Alsarraj is the Biopharma Segment manager at Bio-Rad.

One get obtain a clearer assessment of gene-editing outcomes through more exacting analytical tools.



Using ddPCR to Assess the Success of CRISPR Gene Therapies

Feliza Mirasol is the science editor for 

Having a clear clinical strategy early on can shave time off overall development projects.

Early Strategizing Tightens Development Timelines

Ton van Raalte is cell culture specialist at Thermo Fisher Scientific.

Brian Dalton is senior product manager, Sera, at Thermo Fisher Scientific.

Extensive work has greatly expanded the possibilities for fetal bovine serum sourcing.

Considerations for US Fetal Bovine Serum Sourcing

Editor of Pharmaceutical Technology Europe

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

Advancing Process Chromatography in DSP 

Peter Gaskin, PhD, is the senior director of scientific advisory services for Charles River, an AAPS sustaining partner.

To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.

The Essential Ingredient in any Sponsor-CRO Partnership: Trust

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

Quality Control/Quality Assurance