Quality Systems

FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.

The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.

McNeil Consumer Healthcare Division of McNeil-PPC announced a voluntary recall of three lots of Motrin Infants? Drops after 1 mm plastic particles were identified in a different product lot during manufacturing.

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

Regulatory Authorities Discuss Elemental Impurities Standards

FDA inspections reveal possible inaccurate sterility testing.

Video recorded at Validation Week Canada

Prequalification of Sanofi Pasteur?s Menomune vaccine makes it eligible for purchase by United Nations agencies.

New FDA supply chain policies aim to strengthen inspection and oversight processes.

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?

How good is a reportable value?

Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

Companies exhibit developments for pharmaceutical packaging to meet needs, such as e-pedigree and inspection requirements.

The last few weeks have seen the media swamped with stories about the rampant bribery clawing the pharmaceutical industry in China.

Agencies collaborate to ensure consistent product quality.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

The guidance describes a risk-based approach to monitoring of clinical trials.

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

The US Supreme Court's Myriad decision satisfied both patient groups and patent holders