FDA BE Guidance – Injectables

To facilitate generic drug product availability and assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs. After more than a decade in action, this …

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Safety Assessment of Using Nitrogen Gas in Confined Area

Nitrogen gas is a common inert protecting gas during pharmaceutical manufacturing. It is supplied in either compressed gas cylinders or liquid nitrogen dewars. Continuous usage of nitrogen gas in confined area with limit ventilation or air exchange can pose a serious safety hazard to operators. This article illustrates a practical example of engineering assessment of …

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