Regulation and Compliance - BioPharm International

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Regulation and Compliance

Advancing QbD in the EU

April 1, 2013

EU authorities are stepping up their efforts to incorporate QbD principles.

Achieving More Effective and Efficient GMP Auditing

March 2, 2013

The authors present solutions based on a review of current service offerings and their audit experience.

Quality and Regulatory Leadership: Right-Sizing Need and Cost

March 2, 2013

This article examines the options to best match needs and spending for quality and regulatory leadership.

Vaccine Innovation Yields New Products and Processes

March 1, 2013

Vaccine development is benefiting from manufacturing advances.

Standards-Setting Activities on Impurities

March 1, 2013

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

Europe and the United States to Negotiate a Free-Trade Agreement

March 1, 2013

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

GMP Compliance Becomes Prominent Enforcement Issue

February 1, 2013

Shortages spur efforts to overhaul manufacturing oversight.

Falsified Medicines Directive Takes Shape in Europe

January 1, 2013

The EU fine-tunes the Falsified Medicines Directive.

Drug Quality at Center Stage for FDA and Manufacturers

January 1, 2013

Shortages spur efforts to overhaul manufacturing oversight.

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