Update – January 25, 2009
Guidance for Industry
Submission of Laboratory Packages by Accredited Laboratories
The FDA has issued a guidance document entitled Submission Of Laboratory
Packages By Accredited Laboratories which was intended to provide
guidance to industry about accreditation standards for laboratories and
about the quality and type of test data and information that accredited
laboratories should produce in support of test results submitted to FDA
pertaining to the admissibility of articles offered for import of all
product types (i.e., biological products, drugs, devices, and food) that
they regulate. It is intended to enhance the quality and reliability of
test results submitted by importers to demonstrate that their products
meet the FDA's requirements.
The guidance advises importers how to use accredited labs and makes
recommendations about the quality and type of test data and information
that these laboratories should produce in support of test results
submitted to the FDA.
The guidance is available for review at
http://www.fda.gov/oc/guidance/labpackages.html. The FDA is asking for
your comments.
If you have any questions on this guidance documents on how to determine
which testing labs are accredited you can contact mdi by email:
info@mdiconsultants.com and reference – “Accredited Labs”.
For more information on this please contact mdi at
info@mdiconsultants.com.
|
