May 2008

Feature Article:

Final FDA Rule on Dietary Supplements (21 CFR Part 111)

For Pharmaceuticals:

Pundits Forecast Pharma's Future

For Medical Device:

Top Four Activities to Prepare for ISO 13485 Certification

For Blood & Biologics:

Tracking Blood Electronically

Did You Know?

Did you know that you should be providing a machine readable version of your submissions application form?



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Feature Article: Final FDA Rule on Dietary Supplements (21 CFR Part 111)

In June 2007, the U.S. Federal Food and Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule (21 CFR Part 111) for companies involved in any phase of the manufacturing, packaging, labeling or holding of dietary supplements. The deadlines for meeting the requirements of 21 CFR Part 111 are June 2008 for companies having over 500 employees, June 2009 for companies having between 21 and 499 employees, and June 2010 for companies having fewer than 20 employees.

The final rule addresses the quality of the manufacturing process for dietary supplements and the accurate listing of supplement ingredients. It does not limit consumer access to dietary supplements, or address the safety of a dietary supplement's ingredients or effects on health when proper manufacturing techniques are used.


For Pharmaceuticals: Pundits Forecast Pharma's Future

End of first-quarter economic reports are pouring in and the economic pundits are pondering the industry's performance in 2007 and forecasting pharma's future in the remainder of 2008. If blockbuster drugs are a thing of the past, then what's the next big industry moneymaker?

Most reports cite forecasts of increasingly cost-conscious times. Fewer drugs are receiving FDA approval because of safety issues, not surprising in the wake of recent drug withdrawals and the heparin situation. Expiring patents, the rise in popularity of generic drugs and low reimbursement rates are all negatively impacting the pharmaceutical industry.


For Medical Device: Top Four Activities to Prepare for ISO 13485 Certification

The International Organization for Standardization (ISO) has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485:2003, which provides internationally recognized guidelines pertaining to quality management systems (QMS). Certification to ISO 13485 does not necessarily fulfill the requirements of regulatory agencies such as the U.S. Food and Drug Administration (FDA), but it will bring a company's QMS in line with the FDA's Quality System Regulation (QSR) standards.

The benefits of ISO 13485 certification are numerous: increased efficiency, cost savings, more effective risk management and quality assurance, and an improved ability to respond to customer requirements are just a few of the potential results that certification to ISO 13485 can bring. There are four key activities that your company can undertake to prepare for ISO 13485 certification and ultimately enjoy such benefits.


For Blood & Biologics: Tracking Blood Electronically

Blood centers have been using reliable and easy-to-scan barcodes to positively identify and track blood products for decades. Radio Frequency Identification (RFID) technology has been widely used in other industries with myriad applications for years. Marrying the two technologies for transfusion medicine can make it possible to "read" containers of blood simultaneously, reduce costs, streamline operations, and ultimately prevent mismatched blood at the point of transfusion. The addition of RFID in blood banking has the potential to reduce the incidence of life-threatening transfusion error.

Rodeina Davis, Vice President and CIO for BloodCenter of Wisconsin in Milwaukee, is leading an effort that will set the stage to introduce radio frequency identification (RFID) throughout the complete blood supply chain from donation to patient transfusion.


Did You Know?

Did you know that if you are submitting your eCTD to the FDA via the Electronic Submission Gateway, you should be providing a machine readable version of your application form?
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