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Independent Laboratory
•
Method developers must recommend three
different but eligible laboratories in their PTM
application
•
Method developers may begin the method
developer study right after the protocol has been
approved.
•
AOAC Technical Consultant sends approved protocol
to recommended laboratories and solicits bids from
laboratories
•
Independent Laboratory Study requires contract
between AOAC Research Institute and the selected
laboratory.
•
Only
AOAC Research Institute communicates with
the independent laboratory. All other types of
communication must be facilitated by AOAC RI and
the project manager.
Qualifying new independent laboratories
•
Laboratories complete an application and submit
package of information pertaining to accreditation,
scope, analysts conducting studies, etc…
•
Reviewed by AOAC
•
Review of information can take 20 – 30 business
days
Approved Laboratories
•
AOAC Research Institute maintains a list of eligible
laboratories on the AOAC website for consideration.
•
No guarantee of independent laboratory studies
•
Scope can be modified
Company reviews/selects
quote
AOAC RI establishes
contract
Independent laboratory
conducts study & sends
report to RI
Laboratory invoices RI; RI
invoices method developer;
method developer remits
Technical Consultant sends
report to method
developer
Manuscript Submission
•
Method developer drafts manuscript
•
Manuscript consists of the method developer
study report and the independent laboratory
study report into one comprehensive validation
study manuscript using PTM report template
•
Validation study manuscript and package
inserts/labels are submitted to AOAC RI for peer
review