Drug Development

Articles

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.

Comparing and Contrasting Barrier Isolator Decontamination Systems

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

FDA Moves To Implement New GMP Policies

performs application work for Hach Ultra Analytics

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.

Understanding past & proposed changes to USP Chapter  on Total Organic Carbon

Eric June is chief software architect at AssurX, Inc.

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.

Why Search Matters: Information Retrieval in the Pharmaceutical Industry

This article describes a novel approach to a scale-up management system, based on a holistic view of the scale-up lifecycle and an accompanying electronic development record of the information created.

Integrated Information Management Approach to Drug Substance and Drug Product Scale-Up

The author argues that information technology solutions will play a major part in confirming-by experimental and statistical validation-that bioprocesses may be interchangeable and therefore generic. The bioprocessing ANDA will define both in-house and contract manufacturing.

Challenging "The Process is the Product": Clarifying the Role of Information Technology in Biopharmaceutical Process Development

Pharmaceutical science and technology news

October 2004

Product Spotlight

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The authors review current industry practices and regulatory expectations for the aseptic processing of sterile drugs. They compare and outline critical issues in current manufacturing technology and capabilities with regulatory requirements.

Aseptic Processing: A Review of Current Industry Practice

FDA and industry discuss proposals for regulating combination diagnostics, medical devices, and pharmacogenomic-based drug products.

Process and Scaling