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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA REQUESTS COMMENTS ON VALIDATION DRAFT GUIDANCE DOCUMENTS

FDA Veterinarian Newsletter March/April 1998 Volume XIII, No II

In a January 27, 1998, Federal Register notice, FDA announced the availability for comment of draft Guidance for Industry (GFI) documents on "Validation of Analytical Procedures: Definition and Terminology" and "Validation of Analytical Procedures: Methodology." These draft documents have been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). These are the first documents developed under the VICH process. They are intended to provide guidance on characteristics that should be considered during the validation of analytical procedures included as part of registration applications for veterinary medicinal products submitted for approval to the European Union, Japan, and the United States.

Copies of these documents may be obtained from CVM's Internet Home Page or by contacting the FDA Veterinarian.

In recent years, many important initiatives have been undertaken to promote the international harmonization of regulatory requirements. FDA has participated in VICH efforts to enhance harmonization and has expressed its commitment to seeking scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and reduce the differences in technical requirements for drug development among regulatory agencies. At a meeting held on August 20 and 21, 1997, the VICH Steering Committee agreed that these draft GFI documents should be made available for public comment.

The draft "Validation of Analytical Procedures: Definition and Terminology," discusses the characteristics that should be considered during the validation of analytical procedures. This "Definition and Terminology" document is not intended to cover testing requirements or procedures, rather it is to serve as a collection of terms and definitions. These common definitions such as "analytical procedures," "specificity," "precision," "accuracy," etc., are meant to bridge the differences that often exist among various compendia and requirements of the European Union, Japan, and the United States.

The draft "Validation of Analytical Procedures: Methodology," discusses common analytical procedures and provides guidance and recommendations on how to consider various validation characteristics for each analytical procedure. It also indicates the data that should be included in an application for registration.

Interested parties are encouraged to submit written comments on the draft guidances to the Dockets Management Branch (HFA-305), Food and Drug Administration, room 1-23, 12420 Parklawn Dr., Rockville, MD 20857. Comments should be identified with the full title of the draft guidance and docket number 98D-0017. Comments should be submitted by March 30, 1998.

Comments received on the draft guidances may be seen at the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. After review of these comments, FDA will finalize the guidance document with any appropriate changes.

Further information about this draft guidance document is contained in the January 27, 1998, Federal Register notice. Information on the draft guidance documents is also available from William G. Marnane, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-0678. E-mail: wmarnane@bangate.fda.gov. Further information on VICH is available from Dr. Sharon Thompson, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1798. E-mail: sthompso@bangate.fda.gov.