Top Pharmaceutical Technology News Stories of 2016
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The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.
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The agency published guidance on data integrity as it is relates to CGMP compliance.
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FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain's facility in Puerto Rico.
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What's ahead for the healthcare and pharmaceutical industries?
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The House Committee on Oversight and Government Reform questioned Heather Bresch during a hearing on the company's decision to raise the price of EpiPen more than 400%.
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The companies announced that they have mutually decided to terminate the planned merger after the US Department of the Treasury and the IRS issued temporary and proposed regulations on tax inversion.
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NIH decided to suspend research after facilities were found not in compliance with CGMP practices.
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The agency says, for now, it's business as usual.
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In the wake of Britain's decision to exit the EU, pharma companies face uncertainty.
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The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar to its reference product.
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Top Pharmaceutical Technology Feature Articles of 2016
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The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation is no longer necessary and a risk-based approach should be universally adopted.
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Data integrity is a widespread, global problem that must be addressed.
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In the pharmaceutical factory of the future, data collected by internet-connected manufacturing equipment improves operational efficiency.
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The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
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As specialty API outsourcing grows, manufacturers and contract development and manufacturing organizations are investing for the long haul.
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Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.
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A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing.
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Three-dimensional printing allows unique benefits to be built into solid-dosage forms.
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Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
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The authors provide their perspectives on shipping validation.
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REFERENCE BOOKS |
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A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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More Reference Library |
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eBOOKS
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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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