Quality Assurance/Quality Control

Sterile Injectables Shortages: Can Innovation End A Crisis?

September 02, 2016

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?

Best Practices for Cleaning Validation Swab Recovery Studies

September 02, 2016

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.

FDA awards LIU for research into variability

August 04, 2016

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

Measuring and Removing Genotoxic Impurities

May 15, 2016

Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.

Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

May 15, 2016

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

Pharmaceutical Quality: Where Do We Need to Go from Here?

May 02, 2016

As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.

New Tools Target Speed, Simplicity, and Compliance

April 25, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

Instruments are introduced for elemental impurity analysis and materials identification.