Displaying 101–125 of 518 results for PAT

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Soaring Innovation, Grounded Goals

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Readers recognize tools that break new ground but promise to improve efficiency

On-Demand: Ensuring Pharmaceutical Product & Process Quality with ...

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More than 20 on-demand webcast presentations from industry experts and leading solutions providers. NIR, Raman and Particle Characterization technologies and applications that are improving pharmaceutical product and process quality.

Tailoring Production to Demand at Pfizer

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The company’s manufacturing facility in Freiburg, Germany, uses an approach that maximizes flexibility and segmentation

A Practical & Structured Approach To Deploying Process Analytical Technology ...

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Let’s redefine PAT as the Practical Application of Technology

From the Editor: Protecting the Wind

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What would happen if everyone tried to patent good science, and the way to a good Design Space?

Real-Time Viable Particle Detection: Benefits, Challenges, and Regulatory Needs

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Real-time viable particle counters present clear opportunities for pharma, but also unique challenges—among them, the need to update regulatory guidance for Rapid Microbiological Methods.

Biomanufacturing Shows Signs of Maturity, PAT Adoption

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Manufacturers are reporting fewer batch failures, adopting PAT and other quality initiatives, and stepping up supply chain quality control.

Therapeutic Dose: Who's on First?

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When it comes to QbD, we keep using that word, but does it mean what we think it means?

Bioprocess Filter 411: A Look at New Products for 2012

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Solution providers churn out new and improved products in the heated market for upstream and downstream filtration technology.

Therapeutic Dose: Reforesting Innovation

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Trade show consolidation can be a good thing, at least when it gives smaller innovator companies room to grow.

From the Editor: Pangloss or Popper: Has Drug Manufacturing Advanced in the ...

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Can drug manufacturing reach its potential without standards, science and an admission that there’s a need for improvement?

Afnan: Channeling Don McLean

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Standard work definitions, and recognized standards, will improve drug manufacturing—not nostalgia, or the insistence that “pharma is different.”

The Pulse of Pharmaceutical Manufacturing

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The big picture has changed very little in ten years. While pointing out root causes, observers also see reasons for optimism.

From the Editor: The Cost of Poor Quality, Too High a Price?

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Assessing the cost of poor quality doesn’t just prevent disasters; it’s good for business.

From the Editor: A Culture of Arrogance

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Analysts say that 2012 may prove to be pharma’s most challenging year ever.

From The Editor: First, Do No Harm

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Modern control is the best way to ensure patient safety (and corporate survival).

Studying Outliers to Ensure Ingredient and Product Quality

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Out-of-trend results from APRs offer unique insights into ingredients and finished products.

Therapeutic Dose: Sampling: Good News, Bad News

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Changing from the status quo to meaningful testing will satisfy both FDA and ASTM.

QbD: Redefining Time to Market

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For manufacturers who lack formulation and process knowledge, the benefits of getting to market fast can be outstripped by the costs of unexpected failures.

Ali Afnan: Pharma Faces a New Year: Will it Mirror, or Break Away From, the ...

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Effective change must improve business performance, and not just a process.

Therapeutic Dose: Fractal Pharma

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When the whole so closely resembles the individual parts, where is the big picture, or the path to continuous improvement?

Solvent Recovery at Pfizer: A Continuous Solution for Small Waste Streams

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When equipment and processes challenge solvent recovery for small-volume streams, an atypical approach is needed, says Pfizer’s Frank Urbanski.

Industry Thought Leaders Share Visions and Lessons about Quality for ...

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In a recent talk, Ajaz Hussain, former FDA Deputy Director of the Office of Pharmaceutical Science (OPS), reminisces about the Agency's 21st Century initiative and looks ahead to challenges yet to be addressed.

Chatterjee: Automation Standards, Statistics and Process Validation

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Revived interest in SPC only heightens the need for new data architecture models

Closed System Control: From Defense to Pharma

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Authors from Pfizer and Rockwell Automation propose a closed-control scheme for pharmaceutical PAT.

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