FDA Issues Guidance about Laboratory Packages

January 22, 2009
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories.

Rockville, MD (Jan. 15)-The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories. The document’s purpose is to enhance the quality and reliability of test results that importers submit to FDA to demonstrate that their products meet requirements. The guidance advises importers about how to use accredited laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce to support test results submitted to FDA. Nonaccredited laboratories are not affected by the draft guidance.

The draft guidance defines accreditation as “a rigorous assessment, conducted by an independent science-based organization, to assure the overall capability and competency of a laboratory and its Quality Management Systems.” FDA recommends that a laboratory establish standard operating procedures and be accredited for the specific test methods it uses to generate data for submission to the agency, according to the draft guidance. In addition, the draft identifies criteria to help a laboratory choose an accreditation body and the elements that body should assess. After a laboratory has been accredited, FDA will recognize its competence to conduct the specified test methods.

FDA will allow accredited laboratories to submit abbreviated laboratory packages containing data about the product to be imported. Abbreviated laboratory packages consist of documents identifying the entry from the importer of record, a Summary of Analysis, and the laboratory director’s affirmation that the data are accurate, complete, and uninfluenced by the importer.

The draft guidance requests importers to notify FDA in advance about the product in question, the accredited laboratory that will perform the analysis, and the test methods it will conduct. This provision is intended to discourage importers from withholding bad test results, retesting, or resampling, according to the draft. The information provided in the advance notice will also help FDA manage its workload and schedule its observation or audit of the sampling procedures.

The draft guidance reflects “FDA’s continued vigorous efforts to minimize the chances of unsafe products reaching American consumers,” said Jeffrey Shuren, associate commissioner for policy and planning, in an agency press release.