Quality Assurance/Quality Control

May 15, 2016
Pharmaceutical Technology
Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
May 15, 2016
Pharmaceutical Technology
Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.
May 02, 2016
Pharmaceutical Technology
As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.
Apr 25, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Instruments are introduced for elemental impurity analysis and materials identification.
Apr 04, 2016
Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.
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.
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