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Raw Material Variability

April 1, 2014

The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.

Achieving Supply Chain Excellence in Single-Use Systems

March 1, 2014

For single-use systems, supply chain excellence requires a commitment to problem solving across organization boundaries.

Risk Aversion and Closed-System Processing

November 1, 2013

Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.

Flexibility in Biopharmaceutical Manufacturing

June 1, 2013

Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.

Benchmarking: Don't Just Run the Numbers, Understand the Process

April 1, 2013

Benchmarking can be a useful tool to improve manufacturing practices.

Relevance Regained

February 1, 2013

Improvement strategy should be linked to business strategy.

The Transformation to Process-Centered Organization

November 1, 2012

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

Streamlining Batch Record Review and Approval

August 1, 2012

A one-day sign off for batch records is considered a best practice in the industry.

Using a Systematic Approach to Select Critical Process Parameters

July 1, 2012

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.

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