Validation Process

Types of Validation

AOAC has offered methods validation services since 1884 (starting with fertilizer analyses). For many years, the only type of validation led to the Official Method status, after rigorous testing with well-characterized samples in numerous labs showed acceptable precision and interlaboratory agreement. The main AOAC web site has good documentation on three of these validation procedures: Official Methods of Analysis, Peer-Reviewed Methods, and Performance-Tested methods.

In a world where methods to test for biological hazards must be developed and validated rapidly but rigorously, AOAC now offers different types of validation appropriate for different situations. The Gold Standard remains the collaborative study, leading to Official Final Action and listing as an Official Method. But a test that is intended to be performed in only one laboratory (or within one company) can be validated within that lab in much less time; the Single Laboratory Validation (SLV) has been invaluable to the Dietary Supplements industry.

Single-Laboratory Validation (SLV)

SLV (or Peer-Reviewed Methods) is an excellent first step towards a full Official Method validation; it is a rigorous testing step that effectively debugs the method before the long, slow, and costly full collaborative study. Once a method has been validated within one's own lab, it has a good chance of succeeding relatively rapidly in other labs. At the moment, SLV has been used only in Dietary Supplements applications, because each company has its own proprietary formulation and needs a unique method.

AOAC has prepared a set of guidelines for conducting an Single Lab validation (download as a PDF file): AOAC Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals

Getting Started with Your Validation

Unless your method has been designated by the Community as a high-priority method, you must pay a fee for a validation. The amount depends on what sort of validation you want; discounts are offered to Organizational Affiliate memberships.

If you have developed a method for which you want AOAC validation, contact Anita Mishra for information on fees and getting started with the process. After the bookkeeping step, you may want to have AOAC schedule a conference call with the project managers and the General Referee to discuss your next step and clear up any questions you have. AOAC is committed to expediting your validation and will find the resources you need to succeed as quickly as possible.

Once you have paid fees and are ready to start the process, AOAC can organize a conference call to help you understand the next steps in the process. You will have a project manager assigned to your method to keep things moving along and to answer any questions you have. A page on this web site called " Training Materials" contains links to a wealth of useful advice on choosing samples, selecting labs, and writing your protocols and methods.