Regulatory Review Trends and Updates
Contributor Angelo DePalma surveys the regulatory landscape to help readers stay up-to-date on the FDA's latest policy and organizational initiatives as well as its efforts to field better trained inspectors. DePalma furthers the discussion talking to Pharma company executives about their compliance strategies and programs designed to forward their compliance agendas internally.
Technology at Work
Pfizer Tests Sealing Integrity Inspection System
Pfizer Global Supply is set to perform a three-month trial of DIR Technologies' thermal imaging-based packaging integrity testing systems. DIR is installing a 100% inspection system so Pfizer can evaluate the speed, accuracy and cost of the systems and its potential to replace the destructive seal integrity testing it currently deploys across a number of packaging operations.
Greater Process Understanding from Particle Characterization
Thomas De Beer and Fien De Leersnyder of University of Ghent, Belgium and Ian Jones and Chris O'Callaghan of Innopharma Labs monitored wet granule size at the outlet of a twin screw granulator on a GEA Consigma 25. In this trial, an integration system was developed which allowed Innopharma Lab's Eyecon characterizer to capture and analyse images of the granules without interrupting the vacuum transfer line to the continuous drier. The measured material could therefore be fully dried and captured at the process end for further offline analysis.
Proactive Quality & Compliance
A Business Case for Stage 3- Continued Process Verification
Apotex Inc.'s Daniel Alsmeyer, Scientific Leader, Statistical Support and Ajay Pazhayattil Technical Operations-Process Validation Manager discuss how implementing Stage 3-Continued Process Verification makes good business sense by reducing process-related failures and overall quality costs. Improved process controls, lower failure rates, and better manufacturing planning frees up production lines and provides for a higher throughput of the manufacturers portfolio. According to the authors, the ultimate result of a well-implemented Process Verification Process is an uninterrupted product supply that provides enhanced client service levels.
Information and Data Management
Control System Upgrade Delivers Peace of Mind
company recently completed a control system upgrade at its bulk active pharmaceutical ingredients (API) plant in St. Louis, Mo. This plant is among several manufacturing lines on the 40-acre campus that makes ingredients used for narcotics and other final, salable products.
Supply Chain Excellence
Planning for Surprises in Clinical Logistics
Creating and managing a successful clinical supply chain in today's complex pharmaceutical environment takes holistic planning that includes an ability to adjust quickly and competently to unforeseen changes, according to authors Susanne Mueller, global director Sourcing and Distribution and Robert Mueller, global director depot and production, of PAREXEL's Clinical Logistics Services. Managing IMPs and ancillary supplies is a complex and delicate process, one that's subject to change at every stage. There's also much at stake, from maintaining IMPs that represent millions of dollars in investment to the health of volunteers and patients involved in the trials and eventual treatments.
Battling Bearing Wear and Corrosion
Baldor's Galen Burdeshaw discusses how effective lubrication and contamination protection will help maintain bearing strength and capacity wherever these components are found across the production continuum.
Mixing and Blending
Product round-up from prominent equipment suppliers.
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