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AOAC Research Institute Policies and Procedures
© 2009 - AOAC Research Institute
7
4.2.5 Invoicing:
The AOAC Research Institute will issue an invoice for the PTM application
when the PTM Application package is received at the AOAC Research
Institute. The invoice will be on NET 30-day term from the date of the
invoice.
4.2.6 Refunds:
A refund of one-half of the application fee will be made if the Method
Developer withdraws the application prior to acceptance of a contract with
an independent testing site. No refund will be made once a contract with an
independent testing site is agreed to by the Method Developer and signed
by the AOAC Research Institute Managing Director.
4.3
Independent Testing Site:
The Independent Validation Study Protocol is intended to verify the performance of
the test method under controlled laboratory conditions and to characterize the
method under the intended use conditions. A subset of the intended use conditions
claimed by the Method Developer must be evaluated by the independent testing
site.
The Independent Validation Study Proposal must be accepted by all parties before
testing begins. The AOAC-RI will in turn invoice the Method Developer for
reimbursement, separate from the application fee.
4.3.1 Selection of Independent Testing Site:
The Method Developer may ask the Project Manager to request proposals
from more than one independent testing site. Factors in the selection of an
independent testing site can include cost, timing, technical expertise, and
ease of shipping method components and equipment. A testing site will not
be selected to evaluate a particular test method if that testing site routinely
uses the test method under evaluation. Also, the testing site must not have
a financial, corporate, or regulatory relationship with the applicant and must
not be a competitor.
Preference will be given to qualified testing sites accredited to the ISO
17025 requirements for the appropriate field(s) of testing. If evidence of
appropriate accreditation is not provided, on-site visits by a representative of
the AOAC- RI, at the Method Developer’s expense will be conducted to
assess the testing site's compliance with the General Criteria for
Independent Laboratories (Appendix 8).