2014-03580. Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Analytical Procedures and Methods Validation for Drugs and Biologics.” This revised draft guidance supersedes the 2000 draft guidance for industry on “Analytical Procedures and Methods Validation” and, when finalized, will also replace the 1987 FDA guidance for industry on “Submitting Samples and Analytical Data for Methods Validation.” This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 20, 2014.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Lucinda Buhse, Center for Drug Evaluation and Research, Food and Drug Administration, 1114 Market St., Suite 1002, St. Louis, MO 63101, 314-539-2134; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Analytical Procedures and Methods Validation for Drugs and Biologics.” This revised draft guidance supersedes the 2000 draft guidance for industry on “Analytical Procedures and Methods Validation” and, when finalized, will also replace the 1987 FDA guidance for industry on “Submitting Samples and Analytical Data for Methods Validation.” It discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products and how to assemble information and present data to support analytical methodologies. The recommendations in this guidance apply to new drug applications, abbreviated new drug applications, biologics license applications, and supplements to these applications. The principles in this revised draft guidance also apply to Type II drug master files. This draft guidance does not address investigational new drug application (IND) methods validation specifically, but the principles being discussed may be helpful to sponsors preparing INDs.

This draft guidance complements the International Conference on Harmonisation guidance “Q2(R1) Validation of Analytical Procedures: Text and Methodology.”

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on analytical procedures and methods validation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 211, 21 CFR part 314, and 21 CFR part 601 have been approved under OMB control numbers 0910-0139, 0910-0001, and 0910-0338.

III. Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm,, http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm, or http://www.regulations.gov.

Dated: February 12, 2014.

Leslie Kux,

Assistant Commissioner for Policy.