Pharmaceutical Technology
March 02, 2017
Troubleshooting
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The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.
March 02, 2017
Regulatory Watch
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Policies limiting imports and immigration generate uncertainty for US and foreign firms
March 02, 2017
API Synthesis and Manufacturing
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Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.
March 02, 2017
Ask the Expert
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Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
March 02, 2017
Features
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A survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
March 02, 2017
Features
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A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.
March 02, 2017
Cover Story
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Moving to the next level of productive, reliable performance in bio/pharmaceutical manufacturing requires a willingness to make changes and create a quality culture.
March 02, 2017
Features
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The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
March 02, 2017
Product Spotlight
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The OCEASOFT Loading Bench is an innovation for cold-chain monitoring management for transportation and high-volume shipment.
March 02, 2017
Product Spotlight
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The Pharmafill TC4 Tabletop electronic tablet counter from Deitz Co. automatically counts pills, tablets, capsules, softgels, caplets, lozenges, and other solid oral-dose products and fills them into bottles.
March 02, 2017
Product Spotlight
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Ross, Charles & Son offers a variety of mixers for mixing and blending applications.
March 02, 2017
Product Spotlight
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The Rainin SmartStand from Mettler Toledo includes four pipette holders.
March 02, 2017
Features
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Industry experts discuss IIoT and its impact on pharmaceutical manufacturing.
March 02, 2017
From The Editor
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Drug type, potential sales, and ownership factor in the race to get drugs to market.
March 02, 2017
Features
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Quality metrics are used by FDA and by bio/pharma companies to evaluate manufacturing and fuel continuous improvement efforts.
March 02, 2017
Features
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Pharmaceutical Technology spoke with Frank Generotzky, plant manager for Baxter BioPharma Solutions’ Halle, Germany facility, about operational excellence at the site.
March 02, 2017
Outsourcing Outlook
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Moving global manufacturing operations may be more complicated than it appears.
March 02, 2017
Features
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Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.
March 02, 2017
Peer-Reviewed Research
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This study investigated the stability of solid lactose stored under high temperature and humidity conditions.
March 02, 2017
Formulation
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The authors discuss the challenges of capsule filling in preclinical and clinical studies.
March 02, 2017
Formulation
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Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.
March 02, 2017
Features
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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.
March 02, 2017
Supply Chain
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As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.
March 02, 2017
Supply Chain
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The author discusses the results from TraceLink and Actionable Research's Global Drug Supply, Safety and Traceability Report.
March 02, 2017
Supply Chain
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Johnson & Johnson Supply Chain (JJSC) and the distributor AmerisourceBergen launched a four-week pilot program to test GS1’s EPCIS standards and to see how effectively data could be transferred between the two partners.
March 02, 2017
Issue PDF
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Click the title above to open the Pharmaceutical Technology March 2017 issue in an interactive PDF format.