Cover Story - Special Reports
Generics Industry: Under Pressure
From all corners, the generic drug industry is reacting to growing competitive, regulatory, and financial pressures. Success for generic drug producers and contract suppliers comes from managing risk and assuring quality from the supply chain through to finished product while keeping costs in check. The industry is answering that challenge and increasingly instituting innovative, scientifically based process control methods and technologies that accelerate production and drive efficiencies across the enterprise. Editor Steven Kuehn taps producers, regulators and other players for a view of the innovations and excellence driving the industry today.
Understanding the Good in GDUFA
Coldstream Laboratories' Christopher Verbicky revisits current thought leadership on the impact of the Generic Drug User Fee Amendments (GDUFA) offered by panelists at a recent Interphex conference session. This article reports on the opinions and insight offered by drug makers and the Generic Pharmaceutical Industry Association delivered during the session.
Pharma and Biopharma Operations
Ozone: A New Economic Paradigm for Facility Water Management
According to MKS Sr. product manager Erika Hanley-Onken, making pharmaceutical water is never easy. Trying to make it less expensively can be even more challenging, but there are options available. In the pharmaceutical industry municipally treated water is only the first step. Much more treatment is required to develop the water facilities require to pharmacopoeia standards.
Compliance, QC and QA
A Clear Vision of Perfect Quality Control
Employing a "human sensor" to inspect products randomly cannot meet the demand of perfect quality control. At this level of production, Boehringer Ingelheim gains a clear understanding of label quality from Cognex and Weber Systemtechnik to achieve its quality control objectives.
Supply Chain and Information Management
Supplier Validation Transparency
NorthWest Analytic's CTO Louis Halvorsen covers a raw material/supply chain management project NWA is working on with one of the largest pharma companies. She details how test results, provided by suppliers are integrated into a data platform that provides valuable analytics and dashboards that combine the vendor-provided data with internal testing results in the company's LIMS.
Technology at Work
Product round-up from prominent single-use technology suppliers.
Single-Use Technology Trends
Bioplan Associate's Eric Langer reveals single-use technology trends from the company's annual industry research effort.
Outsourcing Key to Emerging Generic Producer's Business Plans
New contributor Lina Genovesi finds pharma manufacturers are increasing their outsourcing to less regulated countries, but the challenge is assuring these relationships are efficient, cost-effective and assure quality. Genovesi offers guidance and input from the industry on what to look out for, out there.
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