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August 04, 2016
A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.
May 15, 2016
Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.
Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
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.
April 25, 2016
Instruments are introduced for elemental impurity analysis and materials identification.
April 04, 2016
Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.
April 02, 2016
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.
Understanding of the risks associated with FMEA is crucial in lot release testing.
Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
February 02, 2016
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.