Groundbreakers: Facilities Leading Pharmaceutical Modernization
Leveraging the very latest in bioprocessing technology and plant and process design, Baxter's new Covington, Ga. facility and DSM's cGMP facility in Brisbane represent the state-of-the art in pharma manufacturing. Truly innovative, editor-in-chief Steven Kuehn takes close look and reveals how these two new plants are breaking new processing ground and leading the industry's manufacturing renaissance. A review of ISPE's Facility of the Year winners will accompany the feature as well.
Technology at Work
Meeting Pharma Coding Challenges Head-On
NeilMed Pharmaceutical produces packages and codes its own pharmaceutical products at its 54,000-sq-ft manufacturing facility in Santa Rosa, CA. Regulatory and quality requirements compel NeilMed to apply precise coding that needs to be clear, legible, accurate and lasting. Compliance is assured by employing an ISO 13485 process, which is a Quality Management System that ensures compliance with regulatory requirements for medical devices. In this case study, Videojet printing solutions reveals how its technologies allow Neilmed to meet its coding challenges head on.
Beyond SOPs: Bringing the Rigor of QbD to Analytical Method Development
As the philosophy and techniques enshrined in Quality by Design (QbD) become second nature to the pharmaceutical industry their application is spreading. According to Malvern Instrument's Paul Davies and Paul Kippax, the process of developing, validating and deploying analytical methods closely parallels product development and can similarly benefit from the systematic and scientific approach that QbD promotes.
Proactive Quality & Compliance
Endotoxin: Quality Control in the Pharmaceutical Industry
Author Vinod Jyothikumar, PhD, University of Virginia says quality control is a part of good manufacturing practice (GMP) regulations concerned with the sampling, specifications, and testing of materials, as well as the organization, documentation, and issuing procedures which ensure that the necessary and relevant tests are carried out. To help ensure the correctness of analytical procedures, GMPs require validation to provide documented evidence that every method, instrument, and material/reagent produces the expected results.
Information and Data Management
The Pharmaceutical Manufacturing Imperative: Transform Now
From geopolitical and economic macro trends to global threats to health and the environment, business change is now maddeningly unpredictable and capricious. Thermo Fisher Scientific's informatics lead Kim Shah finds that absent a proactive plan to address these new business realities, pharma companies are in for challenging future. When LIMS are tightly integrated with other enterprise operation systems such as ERP, says Shah, insights from the lab have the potential to be even more central to businesses seeking true enterprise-wide agility.AN, NIR and other popular techniques.
Supply Chain Excellence
Packaging Strategies for Lyophilized Substances
Lyophilization is particularly advantageous for complex and highly sensitive substances. Vetter's Thomas Otto notes freeze-drying increases a drug's resistance to heat, light, and other external influences. However, development, manufacturing and delivery of such substances demands different packaging requirements than with liquid formulations and the packaging technology choices one makes can support an effective delivery strategy.
Fluid Control – Pumps & Valves
Product round-up from prominent equipment suppliers.
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