AOAC Conformity Assessment

AOAC Research Institute Policies and Procedures

estimate invoice is paid.

4.4

Method Developer Validation Study:

Method Developers are responsible for collecting data for the Method Developer

Validation Study. The study should conform exactly to the Method Developer

Validation Protocol in the Validation Outline developed during the consulting phase.

Any question(s) or proposed deviation(s) from the Method Developer Validation

Study Protocol must submitted to the Project Manager before data collection begins.

The Project Manager will confer with the General Referee/Topic Advisor regarding

the question(s) or proposed deviation(s) and report back to the Method Developer.

Method Developers may collect Method Developer Validation Study data at their

own facilities, or the Method Developer Validation Study may be contracted out to a

contract vendor. Results from Method Developer Study must be included in the

Method Validation Study Report.

4.5

Method Validation Study Report and Review:

Method Developers are required to prepare and submit a Method Validation Study

Report supporting the intended use claims of the method. See Appendix 11 for the

Method Validation Study Report template. The Method Validation Study Report

must include the results of the Method Developer Validation Study and the

Independent Validation Study, including all original and retest data.

The current draft package insert and/or user manual is reviewed at the same time as

the Method Validation Study Report to ensure that the package insert and/or user

manual is complete and accurate. Appendix 12 describes the basic requirements

for package inserts.

The Method Validation Study Report and draft package insert and/or user manual

shall be submitted directly to the Project Manager, who will forward the documents

with the appropriate review form to the General Referee/Topic Advisor and Expert

Reviewers. It is the responsibility of the Project Manager to set deadlines during the

review process and track progress of the reviews. Generally, reviewers are asked

to provide comments and questions within 2 weeks for the first review and 1 week

for each review thereafter.

Upon receipt, the Project Manager shall forward each reviewer's review form to the

Method Developer. The Method Developer is responsible for responding to all

reviewer comments and questions in writing. All responses and revised documents

shall be submitted to the Project Manager, who will forward them to the General

Referee/Topic Advisor and Expert Reviewers for additional comment or approval.

The process continues until consensus is reached among the three reviewers for

either approval or rejection.