Quality Systems

The author outlines the key concepts of ISPE's recently revised Baseline Pharmaceutical Guide for New and Renovated Facilities. This article is part of a special supplement on Excipients and Solid Dosage.

The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Though many advantages are associated with the European Clinical Trials Directive, complexities have emerged since its introduction in 2004. Since 2007, efforts have been made to raise the issues and address the negative impact of the Directive.

Though the pharma industry has improved its change management processes, there are still opportunities for improvement.

The pharmaceutical industry must understand its responsibilities to improve the safety of chemicals as defined by the REACH initiative.

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

FDA Issues Warning Letter To Pfizer; And More.

The US Pharmacopeial Convention recently held its convention in Washington, DC.

An evaluation conducted by Ernst & Young assessing the effectiveness and efficiency of the European Medicines Agency has largely praised the agency; however, a number of strategic and operational recommendations for further improvements have also been made.

INTERPHEX 2010 will take place this week at the Jacob K. Javits Center in New York.

After several years of debate and review, the US Food and Drug Administration is calling for the removal of metered-dose inhalers.

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

The US Pharmacopeial Convention will hold its governance meeting next week in Washington, DC.

FDA Issues Warning Letters to Six US Medical Spas; and More.

The US Pharmacopeial Convention welcomed Minghao Zhou of China's Zhejiang Provincial Institute for Food and Drug Control.

Eli Lily Wins Court Battle; Genzyme Appoints COO; And More.

Collaboration has been key to the pharmacopeia's achievement.

Tablets and capsules are mainstay product forms, so what are the spending and innovation trends for solid-dosage manufacturing equipment and machinery?

As drug manufacturing and standards grow, pharmacopeias must adapt to meet new challenges.

Laboratory personnel share interesting tales as well as stories of unexpected tails.

As demand for global vaccine development and production grows, all eyes are turning to Asia.

FDA lacks resources to manage expanding postmarketing responsibilities.

New information improves an organization's guide to building manufacturing facilities.

In 1995, pharmaceutical regulation in Europe underwent a dramatic change with the emergence of the European Medicines Agency. The agency's 15-year history has been eventful, with it having to adapt to a changing regulatory landscape and new expectations from those relying on it for guidance.

The US Government Accountability Office issued a report that's largely critical of FDA's efforts to fully use practices for effective strategic planning and management.

WHO Releases Draft Guideline For Production And Control Of Specified Starting Materials.