Proposed Rules. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 00-22143 · Docket No. 00D-1424

Summary

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation.” This draft guidance is intended to provide recommendations to applicants on submitting analytical procedures, validation data, and samples to support the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to drug substances and drug products covered in new drug applications (NDA's), abbreviated new drug applications (ANDA's), biologics license applications (BLA's), product license applications (PLA's), and supplements to these applications.

Dates

Submit written comments on the draft guidance by November 28, 2000. General comments on agency guidance documents are welcome at any time.

Supplementary Information

I. Background FDA is announcing the availability of a draft guidance for industry entitled “Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation.” This draft guidance is intended to assist applicants in assembling information, submitting samples, and presenting data to support analytical methodologies. The recommendations apply to drug substances and drug products covered in NDA's, ANDA's, BLA's, PLA's, and supplements to these applications. The principles also apply to drug substances and drug products covered in Type II drug master files. The principles of methods validation described in this guidance apply to all types of analytical procedures; however, the specific recommendations in this guidance may not be applicable to certain analytical procedures unique to products such as biological, biotechnological, botanical, or radiopharmaceutical drugs. This draft guidance is being issued consistent with FDA's good guidance practices (62 FR 8961, February 27, 1997). It represents 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 statute, regulations, or both. II. Comments Interested persons may submit to the Dockets Management Branch (address above) written comments regarding the draft guidance by November 28, 2000. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Copies of this draft guidance for industry are available on the Internet at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm. Dated: August 18, 2000. Margaret M. Dotzel, Associate Commissioner for Policy. [FR Doc. 00-22143 Filed 8-29-00; 8:45 am]