Formulations and Process Specification Software

This is the first of many online tutorials demonstrating the functionality of Mar-Kov Recipe Manager Express. Recipe Manager Express is a (free) tool for creating chemical formulations/recipes, and generating batch sheets. This first tutorial shows how to specify a Bill of Materials and print a batch sheet.

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FDA Way Behind in Inspections of Overseas Manufacturers

The FDA is so behind in inspecting overseas food, drug and medical devices that in some cases, it will take centuries to clear the backlog.

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FDA Report Cites 49 Safety Issues At Merck Vaccine Plant

Between November of last year and this past January, the FDA "cited 49 areas of concern, including a failure to follow good manufacturing practices" at Merck & Co. Inc's vaccine plant in Pennsylvania.

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FDA, MIT to Collaborate on Drug Safety

The Food and Drug Administration and Massachusetts Institute of Technology announced Thursday an agreement to develop an automated system to detect unanticipated problems with prescription drugs and medical devices.

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FDA Forms Internal Nanotechnology Task Force

Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced the formation of an internal FDA Nanotechnology Task Force. The new task force is charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.

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Blogging Trends in the Pharmaceutical Industry

Blogs about the pharmaceutical industry abound; but pharmaceutical companies, with all their legal, regulatory, and FDA compliance concerns, have been apprehensive about embracing this fast paced content.

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FDA regulations for the Dietary Supplements industry now require cGMP

On June 22, the U.S. Food and Drug Administration announced that it was releasing a final rule establishing requirements for current good manufacturing practices (cGMP) for dietary supplements.

The rule applies to companies involved in manufacturing, packaging, labeling, and storing dietary supplements.

The final rule requires quality control procedures, testing ingredients, and testing finished products. It also introduces recordkeeping requirements.

Manufacturers will be required to evaluate the identity, purity, strength, and composition of their dietary supplements. Any supplements that contain contaminants, or that do not contain the dietary ingredient(s) they are labeled as containing, the FDA will consider them adulterated or misbranded.

The final rule aims to:

• Ensure that dietary supplements are produced in a quality manner

• Ensure that dietary supplements do not contain impurities

• Ensure that dietary supplements are accurately labeled

• Prevent inclusion of the wrong ingredient(s)

• Prevent inclusion of too much or too little of the dietary ingredient(s)

• Prevent contamination

• Prevent improper packaging
  

The final cGMP will be effective August 24, 2007. To minimize disruption to the industry, the FDA is employing a phase-in plan. Companies with more than 500 employees must be compliant by June 2008, companies with fewer than 500 but more than 20 employees must be compliant by June 2009, and companies with fewer than 20 employees must be compliant by June 2010.

Sources:

FDA Backgrounder:
www.cfsan.fda.gov/~dms/dscgmps7.html

FDA FactSheet:
www.cfsan.fda.gov/~dms/dscgmps6.html

FDA Press Release:

www.fda.gov/bbs/topics/news/2007/new01657.html