Food and Pharmaceutical Testing Laboratory Accreditation Program

Offering accreditation services to food testing laboratories since 1998, A2LA is the most experienced food testing accreditation body in the United States.

A2LA’s Food and Pharmaceutical Testing Laboratory Accreditation Program encompasses laboratories performing chemical and/or microbiological analyses in the examination of the following:

  • Pharmaceuticals
  • Food products
  • Ingredients in the production of food
  • In-process food samples
  • Environmental samples pertinent to foods
  • Final products

This specialty program is covered by the A2LA chemical and biological fields of testing.

Program Requirements

  • ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
  • AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals—An Aid to the Interpretation of ISO/IEC 17025:2017* 
    • The AOAC guidelines (while considered a "guidance" document by AOAC) are used by A2LA as accreditation requirements, as they provide detailed criteria to aid in assessing the essential requirements for performing these types of analyses. The document also provides a section-by-section interpretation of the general ISO/IEC 17025 requirements as they apply to a life science laboratory and contains additional accreditation criteria found in the appendices.  
      • Appendix A discusses typical laboratory equipment and offers additional requirements on calibration, verification, and maintenance schedules
      • Appendix B contains specific criteria for microbiology, including organisms, media, and reagents/kits
      • Appendix C defines acceptance criteria for calibration data in chemistry
      • Appendix D offers additional criteria on pharmaceutical products as it relates to cGMP requirements
      • Appendix E offers specific criteria for dietary supplements, including validation, proficiency testing, and equipment
  • Optional Requirements for the Accreditation of Field Work 
    • A2LA also offers additional requirements for laboratories performing tests in the field (i.e., at other than a permanent laboratory site).

*These documents have been identified by the Food and Drug Administration (FDA) as the type of model they would utilize in conjunction with the application of the Food Safety Modernization Act (FSMA).


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