Manufacturing

The concept of the the triple bottom line incorporates a company's financial, social, and environmental performance. As a result, an increasing number of companies are investigating how sustainable, green technologies and practices can help them stay competitive in a challenging regulated market.

Decontaminating pharmaceutical manufacturing facilities is essential for producing safe and pure drugs. The most commonly used decontaminant in the industry has been sublimated formaldehyde.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the August 2008 edition from OYSTAR Manesty and Hawk.

The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency's Sentinel Initiative.

Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...

The House Committee on Energy and Commerce issued a revised discussion draft to the Food and Drug Administration Globalization Act of 2008.

Next week, the US Food and Drug Administration's communications with pharmaceutical companies will change, and the agency will begin issuing complete response letters in place of approvable letters.

Bristol-Myers Squibb is seeking to acquire the biopharmaceutical company ImClone Systems (New York) for $4.5 billion or $60 per share. BMS currently holds a 17% stake in ImClone.

The US Food and Drug Administration released its user fee rates for fiscal year 2009 last Friday.

Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...

CMOs expand capacity and capabilities in high-potency manufacturing to meet strong demand for cytotoxic and other potent drugs.

Patent pressures, changing disease profiles, and higher costs force companies to fight for the top.

Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.

This year's meeting of the Controlled Release Society unveiled a plethora of research insights.

Myth versus Reality: What does Q10 implementation really mean for my company?

Editors' Picks of Pharmaceutical Science & Technology Innovations

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

FDA is modernizing adverse-event reporting as part of a revolution in drug-safety assessment.

After five years in the making, the official pharmaceutical quality system is here. All three parties to ICH adopted a final version of Q10 and agreed to implement the guideline through their individual regulatory bodies.

Postponement of California's deadline gives the supply chain time to refine ePedigree solutions.

Despite its flaws, a recent release fills a need for books about pharmaceutical project management.

The authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.

A sponsor company must investigate the manufacturing automation and systems, laboratory automation and systems, information-technology infrastructure, and business applications of each potential contract manufacturing organization.