RSS Feeds How-To
More Information

Related Links

Patricia Santos-Serrão
More Information

Steve Husk, CEO of FRSGlobal
More Information

Michael Rasmussen, Corporate Integrity, LLC
GRC Intelligentsia Blog

David Cornwell's blog on PleaseTech
More Information

ComplianceHome
More Information

Recent Posts

2008 - The Year of the eCTD
Read Post


Patricia Santos-SerrĂ£o, RAC

What are the concerns about BPA?

Nov 14, 11:48 AM

As an expectant mother (for the first time) I have been reading many books and information on the internet about safety concerns about various different products that a baby may be exposed. I recently started noticing, when shopping for baby bottles, that a number of the packages had statements that read “BPA Free” or “Does not contain BPA” and wondered, “What is BPA? and why do all of these companies feel it is so important to make this statement on their packaging in large bold letters.

BPA is a chemical that is widely used to make hard, clear plastic water bottles, as well as baby bottles, and in nearly every soft drink and canned food product. The chemical appears to have estrogen-like effects, and in animal studies it appears to accelerate puberty and pose a cancer risk.

The Food and Drug Administration (FDA) however has said that the levels of BPA to which children and adults are exposed do not pose a meaningful risk. As expected others feel differently, not so much about the medical findings but about the methods the FDA used to come to this conclusion. A scientific panel stated that the FDA as ignoring crucial studies and using what it said were flawed methods in reaching its conclusions. This same scientific panel concluded in a report that the agency’s evaluation of BPA “creates a false sense of security” and “overlooks a wide range of potentially serious findings,”.

Whether or not the FDA will ban the use of BPA in the future or not is unknown, however given the diverse use of this chemical, once can only imagine the magnitude of the impact that banning this chemical would have on hundreds of manufacturers. This would require significant change control on existing manufacturing processes, and SOPs, emphasizing the importance of maintaining validated and well documented manufacturing processes. Something that the pharmaceutical, biotech and medical device industries are very familiar with when dealing with changes in both active and inactive ingredients use in product manufacturing. The use of technology is critical in maintaining streamlined and well documented process management. For more information see http://www.qumas.com/solutions/quality-management-solutions.asp

 
 
 
Textile Help