Manufacturing

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

In response to stringent price cuts introduced in Spain, the European Generics Association (EGA) is urging the Spanish government to adopt mechanisms that will help increase the dispensing of generic medicines.

The biotechnology markets in the United States, Europe, and Canada, and Australia reached aggregate profitability in 2009, according to Ernst & Young.

The US Food and Drug Administration sent a letter to trade associations of manufacturers, wholesalers, and pharmacies to recommend procedures for preventing and responding to the theft of regulated products.

The year 2016 will see Pfizer barely continue to cling to first place on the Top 10 pharma list, with Merck & Co. and Novartis not far behind.

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

Eli Lilly faces up to the new realities of the bio/pharmaceutical industry through outsourcing.

Defining the Next Five Years.

Manufacturers will pay new fees but anticipate expanded drug use and safeguards for innovation.

A method for determining sample size is finally getting some respect.

FDA wants industry to talk to them about the science underlying process innovations-really.

In this case study of amines, the authors discuss several parameters to be considered in developing a headspace GC method.

Eli Lilly faces up to the new realities of the bio/pharmaceutical industry through outsourcing.

The growth of Brazil's generic-drug market is on a fast track, but what are the projections for the sector's future?

A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.

A Pharma Business Imperative.

Editors' Picks of pharmaceutical science and technology innovations

Agreement on standards for excipient qualification, development, and fair pricing is underway.

A modular approach to biopharmaceutical production could bring process flexibility, and contract manufacturing organizations are beginning to take notice.

When vessels, seals, and cooling units go haywire, operators must get in the mix.

Cameron Tew explains why effective New Product Planning is the first line of defence against losses caused by product failures.

The author discusses a new fillm-coating system to create customized colors and the research an development tools used in conjunction with this system. This article is part of a special supplement on Excipients and Solid Dosage.

A Technical Forum featuring representatives from Dow Chemical, ISP, and DMV-Fonterra Excipients. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

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 author proposes techniques, based on Six Sigma methods, for monitoring such processes to discover their airflow patterns and reduce opportunities for spillage.This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."