Quality Assurance/Quality Control

Jan 02, 2016
Pharmaceutical Technology
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
Dec 07, 2015
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.
Sep 02, 2015
Pharmaceutical Technology
QbD is improving the safety of solid-dosage drug products as well as improving manufacturing processes, despite some industry reluctance.
Sep 02, 2015
Pharmaceutical Technology
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
Sep 02, 2015
Pharmaceutical Technology
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.
Sep 01, 2015
Pharmaceutical Technology
To enable efficient monitoring systems, life-science companies need to effectively apply run rules.
Aug 02, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.
Aug 02, 2015
Pharmaceutical Technology
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.
Jul 15, 2015
Equipment and Processing Report
Checkweighers, metal detectors, x-ray inspectors, leak detectors, headspace analyzers, and optical inspection systems for packaging were demonstrated at INTERPHEX 2015.
Jul 09, 2015
By Pharmaceutical Technology Editors
Sepha's VisionScan Max can leak-test full production batches of blister packs.
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