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Pharmaceutical Technology-08-02-2019
Pharmaceutical Technology
Quality Risk Management Plans Create Effective Quality Systems
August 02, 2019
Ask the Expert
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Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
FDA Maps Strategies to Advance Cell and Gene Therapies
August 02, 2019
Regulatory Watch
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New tools and policies aim to support more complex manufacturing processes.
Compact Robotic Systems Integrate with Packaging Systems
August 02, 2019
Product Spotlight
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TaskMate Robotic Systems from ESS Technologies now integrate Fanuc America’s new line of selective compliance assembly robot arm (SCARA) robots to create an ultra-compact robotic cell that integrates with cartoners, case packers, and monoblock filler/cappers for collation and machine loading and unloading.
Floor Mounted Walk-In Hoods for Large Processes
August 02, 2019
Product Spotlight
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UniFlow FM Fume Hoods by HEMCO Corporation are designed for synthesis, distillation, and other reactor or rack type operations where tall apparatuses are used, or large diameter equipment is rolled into the work area.
The Moon, the Stars, and the Science Lab
August 02, 2019
From the Editor
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Fifty years after the man walked on the Moon, space-based science is benefiting Earth.
Advanced Discharge Systems
August 02, 2019
Product Spotlight
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Advanced Discharge Systems by Ross are built with mechanisms to fit almost any high-viscosity application and increase efficiency following the mixing process.
Hygienic Hardware
August 02, 2019
Product Spotlight
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The Allen-Bradley Kinetix VPH hygienic servo motors and the stainless-steel version of the PanelView Plus 7 graphic terminal by Rockwell Automation both work to minimize contamination during production and ease compliance.
Combo Drugs Require a Complex Design Approach
August 02, 2019
Excipients
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A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.
Balancing CMC Priorities
August 02, 2019
Cover Story
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A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
Blending Trace Ingredients
August 02, 2019
Features
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Homogeneity of the powder blend is crucial for solid-dosage drug manufacturing.
Best Practices in the QC Micro Laboratory
August 02, 2019
Features
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Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS Method
August 02, 2019
Peer Reviewed
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The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
Orchestrating Success in Clinical Trial Manufacturing
August 02, 2019
Features
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Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
Accepting the Challenge of Protein Characterization
August 02, 2019
Features
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Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
Formulation and Manufacturing Trends for Parenterals
August 02, 2019
Features
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Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.
FDA Steps Up Enforcement of cGMPs for OTC Drugs
August 02, 2019
Features
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Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.
Real-Time Monitoring Drives New Logistics Solutions
August 02, 2019
Features
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As patient-centered therapies and clinical trials become more important, innovation is providing more control and transparency in the way that pharmaceuticals are delivered.
Pharmaceutical Technology North America, August 2019 (PDF)
August 02, 2019
Issue PDF
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Click the title above to open the Pharmaceutical Technology August 2019 issue in an interactive PDF format.