Register | Login
ZMC 728x90 Blogs
  Parent
  Podcasts
Register Now!
 

Want to post to the discussions? Comment on a Blog?  Register Now.
Search Blogs
NPI Community Blogs
 
Blog Archive
Melamine Testing Method
Location: BlogsAnalysis and Product Quality    
Posted by: jhildreth 5/21/2007 1:43 AM
Many labs are now offering to test products for melamine but are not using the most current GC/MS method for melamine and related analogs that is required by FDA. It is important to make sure you use the correct method otherwise you will be wasting both your time and money. If you have a product that is being held up by the FDA automatic detention you also need to make sure you or the lab you are using is familiar with the specific FDA requirements on data submission to minimize the risk of getting the work rejected by the compliance officer. Details on the method can be found on the FDA website at www.fda.gov/cvm/GCMSscreen.htm.
Permalink |  Trackback
Comments (1)  
FDA Detention Testing    By jamesnealk on 5/21/2007 12:28 AM
This is a very critical point and I am glad that you brought it up. Any company that is having analysis performed by a private laboratory in response to an FDA detention must be sure that they are in compliance with ORA Section 7 and following the current FDA methodology. Following the method is not good enough on its own. In addition, the lab must provide supporting documentation to demonstrate the validity of the test for the sample matrix under test and that the lab is able to perform the test and generate valid data. Further, the lab must document and provide data to show that all scientists involved in the testing are properly trained and have the expertise required to conduct the analysis. There are also very specific requirements for sampling in many cases and in addition to the analysis report, a sampling report is often required as well. The company whose product is under detention should contact the FDA Compliance Officer to be sure that they understand any specific issues or needs that the Compliance Officer might have in regards to the detained lot. There are details regarding this issue on the floraresearch.com website under the news section. In addition, the FDA Office of Regulatory Affairs has detailed documentation regarding this matter. Finally, labs must continuously check the FDA site for the current method(s) since the melamine testing method has changed several times since the issue has first appeared. Labs running older methods may be generating data that will not be accepted by the FDA.
Forslean











We reserve the right to limit or deny your access to the website and/or remove comments or take other appropriate action if you violate any provision of the Terms of Use or if you conduct any activity that violates the rights of any person or entity, or which we in our sole discretion deem unlawful, offensive, threatening, abusive or potentially harmful or malicious.
Copyright New Hope Natural Media, A division of Penton Media | Terms Of Use | Privacy Statement
New Hope Natural Media, A division of Penton Media