Dr. Ludwig Huber, Compliance and Validation Expert
New FDA Guidance Refers to ISO/IEC 17025 for Testing Laboratories
For the first time the FDA refers to laboratory accreditation in an industry guidance (1). The new guidance comes into effect when the FDA denies regulated products (biological products, food, drugs, devices) from import into the United States. In this case the FDA needs information on testing. Testing by accredited laboratories is not mandatory but the FDA offers significant benefits vs. testing done in non accredited laboratories. This article describes advantages of laboratory accreditation and the suggested accreditation standard. In addition it will show how an instrument vendor can help to get accreditation and where to get more information.
Advantages of Laboratory Accreditation
The FDA guidance encourages importers to perform testing in accredited laboratories and offers the following benefits
- To demonstrate compliance the FDA accepts abbreviated test documentation vs. full data sets, including all raw data, if testing is done in non-accredited laboratories. This reduces costs for generating the documentation and reduces FDA’s review time
- Test most likely will not have to be repeated. This also reduces time because importers have not to wait until tests have been conducted and documented.
The FDA has substantial time and cost savings through reduced review time and no need for testing.
Suggested Accreditation Standard
The new FDA guidance recommends to follow ISO/IEC 17011 (2) to accredit laboratories, to make the assessment according to ISO/IEC 17025 standard and to implement the AOAC Implementation Guide for Food and Pharmaceuticals
- The accreditation of a testing laboratory should be issued by an accreditation body operating in accordance with the International Organization for Standardization (ISO) standard ISO/IEC 17011, General requirements for accreditation bodies accrediting conformity assessment bodies. (2) This would help ensure that the accreditation bodies are competent to accredit the laboratories.
- An accreditation body should assess a laboratory’s conformance to ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories-. ISO/IEC 17025 is the most widely used laboratory standard for federal testing laboratories, including FDA’s own laboratories, and ISO/IEC 17025 is internationally recognized and accepted world-wide.
- Additionally, we recommend that laboratories incorporate in their implementation of ISO/IEC 17025 the factors established in the AOAC International “Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025: 2005” which is available from AOAC International.
More Information on ISO/IEC 17025
Reference 3 provides excellent information on how to prepare a laboratory for accreditation. Reference 4 adds specific information for food and pharmaceutical laboratories regulated by FDA. Reference 5 is a free tutorial on ISO/IEC 17025 for analytica laboratories available from Labcompliance. The tutorial will guide laboratory personnel and managers, personnel, and QA managers through the entire process of ISO 17025 accreditation.
Agilent Offerings
ISO 17025 accreditation requires specific from support instrument and service providers. Agilent Technologies has a lot of of experience in helping customers to build up quality systems, mainly through the experience with supporting customers working in FDA regulated environments. Because of the similarity of FDA and ISO 17025 requirements, many of the offerings can be used directly by laboratories working under ISO 17025. Examples are:
- Products are developed, manufactured and supported in documented quality system environment
- Services are develop and delivered in documented quality system environment
- Products have the necessary functions that enable users in regulated and quality standard environments to comply with regulations and standard.
- Services to install, calibrate and qualify products during installation and during on-going operation.
- Free educational seminars and literature with background information and recommendations for implementing regulations and standards
References
- FDA Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories, Draft,
February 2009
http://www.fda.gov/oc/guidance/labpackages.html
- ISO/IEC 17011, General requirements for accreditation bodies accrediting conformity assessment bodies
- 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 and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025: 2005'
- Tutorial, ISO/IEC 17025 in Analytical Laboratories, Labcompliance
http://www.labcompliance.com/tutorial/iso17025