QA/QC

Apr 02, 2016
Pharmaceutical Technology
Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
Apr 02, 2016
Pharmaceutical Technology
Understanding of the risks associated with FMEA is crucial in lot release testing.
Apr 02, 2016
Pharmaceutical Technology
Industry experts and FDA’s Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms.
Feb 02, 2016
Pharmaceutical Technology
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.
Feb 01, 2016
Pharmaceutical Technology
Outsourcing lab analysis offers savings, while “workhorse” techniques can improve the efficiency of such core operations as stability testing.
Feb 01, 2016
Pharmaceutical Technology
Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.
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.
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