Articles by NSF-DBA (USA) LLC - Pharmaceutical Technology

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Articles by NSF-DBA (USA) LLC


Are You Prepared for New Elemental Impurities Guidelines?
June 26, 2013

The pharmaceutical industry is facing great uncertainty about new elemental impurities guidelines from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). These guidelines are currently being developed and have recently reached consensus agreement and will be submitted for public consultation. Even those of us involved in the crafting of the new guidelines know significant changes are coming, but we won't know every detail of the changes until after the ICH approves and publishes the new guidelines. In line with ICH, we also have to contend with revisions to United States Pharmacopeia (USP) General Chapters and approach to elemental impurities. So what do we do until then?

Finding the Balance Between Pharmaceutical Quality Management and Manufacturing Productivity
May 29, 2013

In the pharmaceutical manufacturing industry, our primary concern must always be the quality and safety of our processes and the products we produce. If we don't focus appropriately on developing robust quality management systems, we risk consumer safety and put our companies at risk of regulatory action. Learn more about how to achieve this in this white paper from the experts at NSF-DBA LLC.


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