Quality Systems

In a May 2 Federal Register notice (1), the US Food and Drug Administration withdrew its Jan. 17 direct final rule, "Current Good Manufacturing Practice Regulation and Investigational New Drugs" (2), which would have exempted manufacturing of drugs for Phase I clinical trials from most provisions of 21 CFR 211.

Sigma-Aldrich Corporation (St. Louis, MO) has acquired Iropharm, Honeywell International's custom chemical synthesis business in Arklow, Ireland. Terms of the cash purchase were not disclosed.

China's State Food and Drug Administration prepares to strengthen the enforcement of good manufacturing practices.

Animal testing and accounting can both be hazardous.

At this year's BIO conference, US Health and Human Services Secretary Mike Leavitt predicted that over the coming decade, "Medicine will be transformed from an instinctive art of alleviating symptoms to a science of personalized healthcare." Is industry ready?

Gottlieb challenges industry. First GenerationNext Awards. Implementing PAT. Optimizing site risk. RFID in the supply chain. Biodegradable polyketals. Global drug-market growth moderates.

Manufacturing and formulation innovation spurs drug develop-ment, but raises new safety and quality issues.

The author explores the importance of the proposals to revise Annex 1 of the EU GMPs in the context of the desire for science-based, internationally respected GMPs. Commentary also is provided about the relationship between this annex and CEN–ISO cleanroom standards.

On Feb. 21, the US Food and Drug Administration issued a warning letter to Wockhardt (Mumbai, India), a drug manufacturer. FDA cited the company for violations of CGMPs in the manufacture of drug products and active pharmaceutical ingredients.

The need to curb drug counterfeiting is spurring development of track-and-trace and product authentication technologies.

Eisai plans $105-million plant. Novartis to build plant in China. BMS building $660-million biologics facility. Slow adoption of RFID. Vaccines update. $14.7 billion in pharma construction in 2006. Chiron sells Betaseron to Schering. Baxter to develop cell based H5N1 vaccine. Drug sales up 5.4%, but growth slowing.

Guidance for reducing the risk of dissolved ozone measurement and addresses proper installation, calibration, and verification to ensure the best possible answers from dissolved ozone analysis.

Vitamin D and a sunny window shed som light on product stability.

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

India and China Position for Growth in APIs

Proposed Legislation to Help Fight Counterfeit Drugs

Flu vaccines. Dow veterinary vaccine made in plants. $1.95 billion FDA budget focuses on high-profile programs. Non-injectable insulins win approval. FDA releases guides to dissolution testing, quality overall summary, and new drug-label formats.

Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.

Madness in March: lost ingredients, missed lot numbers, and a million-dollar photo.

USP's proposed General Chapter 1226 "Verification of Compendial Procedures" aims to provide guidance about the verification process.

A new FDA policy emphasizes quality control over GMP compliance in producing clinical trial supplies.

Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.

Warning Letter: Southern Meds

LC–MS–MS has the potential to become a routine technique for determining drug residues in support of cleaning verification, especially early in drug development.

"It was the late 1970s," reports our GMP-Agent-in-Place, "and we used a primitive desktop computer with built-in teletype for our quality control work.

FDA is proposing revisions to the drug user fee program while it weighs changes for drug safety initiatives and expanded vaccine production.

Preliminary results from a clinical trial of Sanofi Pasteur's (Lyon, France, www.sanofi.com) H5N1 prepandemic influenza vaccine indicate the vaccine is safe and was well-tolerated in 300 healthy volunteers. This study is the first trial of an H5N1 prepandemic influenza vaccine candidate that compared vaccines with and without adjuvants.

The regulating authorities have, it seems, a preference for the application of multimembrane combinations to maximize organism retentions.

Baselines are one of the most useful tools in the 'validation toolbox'. They can be used for a variety of tasks with great success. This article will examine how they can be used and for what.

Small- and medium-sized enterprises (SMEs) will gain administrative and procedural assistance from the EMEA. The agency's SME office was launched in December 2005 and follows the new Commission Regulation, which aims to promote the development of medicinal products in SMEs.