Search results for " pharmaceutical" in Articles / App Notes
Article
Regulatory Challenges in the QbD Paradigm
With the dawn of the 21st century came the realization that changes must be made by both the pharmaceutical industry and regulatory authorities across the globe. These changes are necessitated by a pl…
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Understanding Validation and Technical Transfer, Part I
Large-molecule drug products and attendant manufacturing processes often involve complex syntheses and purification steps that differ substantially from those employed for small-molecule pharmaceutica…
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Drug Discovery and Development in India
Over the past few years, Indian pharmaceutical companies have been attempting to re-orientate their efforts toward developing new innovative medicines, Ang Wei Zheng, analyst of Business Monitor Inter…
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Contract Manufacturing Through the Years
…ufacture; Vetter offered bulk syringe filling; DPT had semisolid and liquid capabilities; and Custom Pharmaceuticals, the forerunner of Patheon, manufactured primarily over-the-counter (OTC) products…
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Climate Change in Outsourcing
Government budget cuts also threaten support for pharmaceutical research, especially the work of the National Institutes of Health in the US.
On the positive side, central bank efforts to hold dow…
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Quality by Design—Bridging the Gap between Concept and Implementation
Nonetheless, the pharmaceutical industry has been internally adopting the QbD concepts laid down in the guidelines of the International Conference on Harmonization (ICH) covering pharmaceutical develo…
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Biotechnology Innovation and Growth in Israel
Its dense population and focus on innovation positions Israel well to drive a significant amount of growth for pharmaceutical and medical-device manufacturers.
The infrastructure of…
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Supplier-Change Management for Drug-Product Manufacturers
This article provides an overview of the pharmaceutical SIC process, including a discussion on the need for control of SICs, a review of change notification scope and content, and a summary of how SIC…
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Advancing QbD in the EU
In addition, EU authorities are becoming more concerned about the increasing number of quality defects in pharmaceutical manufacturing that have been causing a rise in drug scarcities.
ICH GUID…
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Using Software in Process Validation
By Robert Glaser
Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…