Articles on analytical & statistical methods, process analytical technology - BioPharm International

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Quality
Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT).

ISPE Releases its Drug Shortages Prevention Plan

October 15, 2014

The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.

Hospira Recalls Certain Lots of Intravenous Products

October 15, 2014

Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

Challenges in Biologic Drug and Vaccine Delivery

October 1, 2014

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.

Application of Quality by Design to Viral Safety

October 1, 2014

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.

Continued Process Verification for Biopharma Manufacturing

October 1, 2014

The authors discuss complications of implementing continued process verification and provide recommended approaches.

Continuous Improvement in Biopharma Manufacturing

October 1, 2014

Unexpected problems can become opportunities to share knowledge and improve processes.

Single-Use Bioreactors for the Rapid Productionof Preclinical and Clinical Biopharmaceuticals

October 1, 2014

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Optimizing Human Performance: A Road Worth Traveling, Part 3

September 3, 2014

This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.

Assessing a Risk Management Program

September 1, 2014

Program review can help quality risk management live up to the promise of ICH Q9.

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