Quality Systems

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.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FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.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CDER withdraws some outdated guidance documents and makes plans to finalize others.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

Siegfried Schmitt of PAREXEL explains how regulatory agencies are getting serious about inspections.

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.

Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.

The bio-pharmaceutical business outlook in South Korea remains positive.

FDA funds research to further development of innovative generics, while working to address review and approval issues.

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.

Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers to better secure the pharmaceutical supply chain.