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Pharmaceutical Technology-03-02-2017
Pharmaceutical Technology
Understanding Containment
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.
International Trade Issues Threaten Global Pharma Operations
March 02, 2017
Regulatory Watch
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Policies limiting imports and immigration generate uncertainty for US and foreign firms
Oral Delivery of Biologic APIs: The Challenge Continues
March 02, 2017
API Synthesis and Manufacturing
41
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Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.
Covering Global Regulations in a Quality System
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.
Risk-Based Predictive Stability–An Industry Perspective
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.
Quality Agreements:Managing Global Relationships
March 02, 2017
Features
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A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.
Achieving Manufacturing Excellence
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.
GMP Facility Modernization: Opportunities for Successful Implementation
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.
Loading Bench for Cold-Chain Management
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.
Tabletop Pill Counter Automatically Counts and Fills Solid Oral-Dose Products
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.
Mixers for Blending Applications
March 02, 2017
Product Spotlight
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Ross, Charles & Son offers a variety of mixers for mixing and blending applications.
Intelligent Stand for Pipette Management
March 02, 2017
Product Spotlight
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The Rainin SmartStand from Mettler Toledo includes four pipette holders.
Integrating Industrial Internet of Things and Pharmaceutical Manufacturing Processes
March 02, 2017
Features
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Industry experts discuss IIoT and its impact on pharmaceutical manufacturing.
Strategizing a Shortcut to Market
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.
Industry experts weigh in on FDA’s Quality Metrics program
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.
Operational Excellence at Baxter BioPharma Solutions
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.
Will Pharma Manufacturing Move Back to the US?
March 02, 2017
Outsourcing Outlook
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Moving global manufacturing operations may be more complicated than it appears.
The Importance of Quality Agreements
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.
An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress Conditions
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.
Overcoming the Challenges of Capsule Filling in Preclinical and Clinical Studies
March 02, 2017
Formulation
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The authors discuss the challenges of capsule filling in preclinical and clinical studies.
Key Considerations in Capsule Filling
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.
Harnessing Advances in Informatics to Ensure Data Integrity
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.
Serialization Hits the Home Stretch
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.
Speed Bumps on the Road
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.
Testing GS1’s EPCIS Standards in the Real World
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.
Pharmaceutical Technology, March 2017 Issue (PDF)
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.