Process Validation

FDA Approves Treatment for Smallpox Vaccination Side Effects

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

In this time of liability reform, pharma deserves the chance to align its economic interests with its ethical obligations to the patient.

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study.

CBER Draft Guidance for Spore-Formers and Plasmid Vaccines

FDA Creates New Drug Safety Board

Lilly Implements Bar Coding on Individual Insulin Vials

Drug Safety Top Issue for New FDA Commissioner Crawford

Generic Drug for HIV/AIDS Gains FDA's Tentative Approval

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

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

Warning Letter

ISA-88 Automation Standard Gains IEC PAS Status

MHRA to Reinspect Chiron Flu Vaccine Plant

FDA Warning Letters December 2004

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

A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented.

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.

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.

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.

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.

Amid the finger-pointing, hand-wringing, and bloviating, the supply of hard, technical information remains frustratingly small.

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

A discussion of the validation and operation of two commercially available vapor-phase hydrogen peroxide decontamination systems is presented, based on a hands-on examination of both systems.

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.

Information retrieval (IR) deals the representation, storage, organization of unstructured applying natural-language processing,semantic relationships, linguistic analyses,behavioral histories, and “fuzzy” statistical techniques to help human quickly find and retrieve the information they seek.

Pharmaceutical science and technology news