Pharmaceutical Technology-08-02-2015
Pharmaceutical Technology
Getting Comfortable With Lean
August 06, 2015
Features
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Contract research, development, and manufacturing organizations (CROs, CDMOs and CMOs) are embracing lean manufacturing, while Big Pharma is applying it, not so much for inventory management, but to improve supply chain visibility and control.
Black Specks in Tablet Stability Samples
August 06, 2015
Peer-Reviewed Research
39
8
A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.
Environmental Containment Performance—Is There Accountability?
August 02, 2015
Formulation
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Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.
Implementing Electronic Production Records
August 02, 2015
Troubleshooting
39
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Paperless operations improve efficiency and increase assurance of product quality.
Understanding Risks in Pharmaceutical Shipping
August 02, 2015
Supply Chain
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Choosing the correct shipping solutions, including packaging, transportation mode, and monitoring, helps mitigate the risks inherent in global logistics.
Outsourcing Becoming More Cost Competitive
August 02, 2015
Outsourcing Outlook
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Biopharma companies are outsourcing more jobs to cut costs.
Regulation of Medical Devices and Companion Diagnostics
August 02, 2015
Regulatory Watch
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The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.
Campaign Against Fake Drugs Gains Momentum
August 02, 2015
Regulatory Watch
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FDA and industry support global framework and collaborations to secure the supply chain.
Defining Crucial CAPA Components
August 02, 2015
Ask the Expert
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Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.
The Bottom Line on Pipeline Progress
August 02, 2015
From The Editor
39
8
FDA notes progress in drug development, but cites scientific and funding roadblocks.
The Potential of Perfusion
August 02, 2015
API Synthesis and Manufacturing
39
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Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
Limiting Risk in Bio/Pharmaceutical Development
August 02, 2015
Features
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Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.
Portable Powder Injection Mixer Improves Handling
August 02, 2015
Product Spotlight
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The Ross Inline Solids/Liquid Injection Manifold (SLIM) Mixer is designed to work with a range of powders that are challenging to mix into liquids.
Syringe Closure System Allows Use of Highly Sensitive Compounds
August 02, 2015
Product Spotlight
39
8
Vetter’s Vetter-Ject closure system for prefilled syringes has an integrated needle hub and shield and is designed for sensitive compounds, such as biologics.
Mass Spectrometer Improves Efficiency
August 02, 2015
Product Spotlight
39
8
Shimadzu’s LCMS-8060 triple quadrupole mass spectrometer is designed for LC/MS/MS quantitation of highly sensitive applications.
Label Printer Improves Compliance
August 02, 2015
Product Spotlight
39
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The YDP30 printer from Sartorius automatically performs thermal transfer or direct thermal printing, without the need to change settings, to meet requirements for fade-resistant printout in regulated areas, such as quality-control laboratories.
Pharmaceutical Technology, August 2015 Issue (PDF)
August 02, 2015
Issue PDF
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Click the title above to open the Pharmaceutical Technology August 2015 issue in an interactive PDF format.
Market Access in China
August 01, 2015
Global Market Report
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China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.