USP monographs, if they are consistently observed and applied, can help reduce medical gas errors.

"It was just after FDA had initiated the Pre-Approval Inspection process," reports our GMP Agent-in-Place.

Oddly for a technical meeting, the Oct. 5–7 AAPS Workshop on Pharmaceutical Quality Assessment focused on words, with an entire session devoted to definitions and countless discussions of meaning and nuance.

As industry moves to real-time feedback control, even conventional syntheses will increasingly resemble living systems.

Moheb Nasr, PhD, director of the newly created Office of New Drug Quality Assessment at the US Food and Drug Administration (Rockville, MD, www.fda.gov), has proposed creating a "regulatory agreement" between FDA and sponsors to govern the chemistry, manufacturing, and controls (CMC) sections of new drug applications (NDAs).

The pharmaceutical industry can leverage best practices from the extremely competitive semiconductor market.

Making active pharmaceutical ingredients (APIs) requires long chains of chemical reactions and large quantities of solvents. Ask API manufacturers how they'd like to improve this process, and the responses are likely to be "make the reactions faster," "make the reactions cheaper," or "make the reactions more efficient." Then after all these economically driven answers, you might here, "make the reactions more environmentally friendly."

Recent advances in transdermal technologies challenge the paradigm that only a few drugs can be delivered transdermally.

Information technology can streamline compliance and increase operational efficiency and quality.

The human race will have colonized Mars long before the pharmaceutical industry brings itself into the 21st century.

A range of insect exterminator equipment has been developed to improve the level of hygiene offered to the pharmaceutical and chemical manufacturing sectors. Berson's Insectron range uses ultraviolet (UV-A) and green light to attract flying insects, which are sensitive to these light sources.

Sigma-Aldrich Fine Chemicals (SAFC) has set up a new business division called SAFC Biosciences to encompass its biopharmaceutical development and cell culture-related manufacturing services.

Biomanufacturing managers believe the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.

Lester Crawford, FDA's top man, has resigned explaining that it was time to step down — despite only being promoted to commissioner earlier this year.

FDA's Evans Reviews Causes of Warnings and Recalls

Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic

Patheon, CEPH Begin Corrective Action Program for Omnicef OP

New Legislation To Ensure Stable Flu Supply

USP Announces Monograph Revisions List and Postponed Publication of General Chapter <1226>

FDA Proposes New CMC ?Regulatory Agreement?

Design Exhibition, ?From Master?s Thesis to Medicine Cabinet?

Collaboration Targets Single-Shot Japanese Encephalitis Vaccine

CEPH International Replies to FDA Warning Letter

CDER Creates Office of New Drug Quality Assessment

Ajaz Hussain Leaving FDA for Sandoz

The US Food and Drug Administration (Rockville, MD, www.fda.gov) released a new draft guidance that may speed generic approvals. The guidance, ANDAs: Impurities in Drug Products, describes the degradation-product information that generic drug manufacturers should include in their abbreviated new drug applications (ANDAs). This clarification, FDA officials say, will help companies submit the correct information, thus increasing the likelihood that their generic drugs will be approved, and approved more quickly.

Confronted by a challenge as vast as Hurricane Katrina, we reach for military organizations for aid and military language for description.

It was, our GMP Agent-in-Place recalls, a typical, small, clinical-type facility... managed in the typical, informal way.