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March 02, 2017
Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall lab efficiency.
February 23, 2017
The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.
February 17, 2017
SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.
February 15, 2017
Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.
February 14, 2017
February 08, 2017
Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.
February 02, 2017
Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.
This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.