Quality Systems

The United States Pharmacopeia should not change its philosophical position on singlet testing.

European Directive 2004/27/EC will have massive repercussions on the manufacture and marketing of APIs and some excipients across Europe...

A look at how process analytical technology promises to be the most radical change in pharmaceutical manufacturing in 30 years...

A look at the role of document management in the product life-cycle and how this can lead to the effective use of CTDs and e-CTDs when compiling compulsory regulatory submissions...

FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.

ISA-88 Automation Standard Gains IEC PAS Status

FDA Warning Letters December 2004

NABP Issues Criteria for "Specified List" of Drugs Susceptible to Diversion

Safety issues and shortages may slow down new drug development and FDA reforms

Comparative studies of the US Pharmacopeia (645) "Conductivity" and the European Pharmacopeia "Heavy Metals" tests were conducted to demonstrate that the USP method can determine the presence or absence of heavy metals in process water samples.

Pharmaceutical Science & Technology News

Pat Survey

Tauzin

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This article provides guidance for developing dissolution testing for poorly soluble compounds. It is the second of a series of articles based on material from a 2003 PhRMA workshop about acceptable analytical practices.

Blockbuster drugs turn out to be risky business, while contamination problems shut down flu vaccine production.

Pharmaceutical Science & Technology News

On the other hand, if we don't keep up the pressure on counterfeiting in the US, we may share the plight of the developing world, where nearly 25% of all drugs sold are fakes.

The collection, investigation and monitoring of suspected adverse drug reactions (SADRs), and associated product use and complaint information, is a regulatory requirement for all manufacturers of pharmaceuticals for human use.1 This process, called pharmacovigilance or drug safety, appears to be fairly standardized between different pharmaceutical companies and usually contains the elements outlined in Figure 1.

Defenders of the research-based industry are hoping for an early Christmas present from the European Court of Justice (ECJ). All the signs are that a small but significant victory is on the way against parallel importing. Right at the end of October, a senior judge responsible for a leading case at the court made clear his view that international drug firms do not necessarily have to make life easy for parallel importers. The formal ruling on the case at issue is expected within weeks.

HHS

This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.

Pharmaceutical Science & Technology News

Phase II of FDA's GMP modernization plan may involve revising regulations to fit new policies and inspection and review programs.

The implementation of a total organic carbon (TOC) method into the United States Pharmacopeia (USP) has its origins in the early 1990s, when the Water Quality Committee (WQC) of the Pharmaceutical Manufacturers Association (PMA, later renamed PhRMA) debated improvements in the testing of purified water (PW) and water-for-injection (WFI). The resulting inclusion of modern analytical techniques replaced much older methods - some of which had been listed in the USP for more than 150 years. Finally, two new regulations were put in place: Chapter for conductivity, which replaced a series of individual ion tests; and Chapter which replaced the oxidizable substances test with a TOC method.