Sterile Manufacturing/Cleaning - BioPharm International

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Sterile Manufacturing/Cleaning

Wockhardt Cited by FDA for Quality Control Failures

June 4, 2014

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

Tandem Diabetes Care Expands Recall

February 13, 2014

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

President Obama Signs Drug Quality and Security Act

December 2, 2013

Drug Quality and Security Act gives FDA authority over compounding pharmacies.

Implementing QbD in Sterile Manufacturing

December 1, 2013

Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.

Label-Free and Labeled Technology for Protein Characterization and Quantitation

September 1, 2010

Use it label-free, or add labels to detect contaminants in solution.

Online Exclusive: Analytical Strategies for Monitoring Residual Impurities

December 18, 2009

Best methods to monitor product-related impurities throughout the production process.

Validation Failure is Not an Option. Should it be?

June 1, 2008

The industry needs to open up to validation failures.

Managing the Global Supply Chain

May 1, 2008

Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.

FDA's Inspection Program Under Scrutiny

April 1, 2008

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.

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