U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Q1A(R2) Stability Testing of New Drug Substances and Products
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Q1A(R2) Stability Testing of New Drug Substances and Products November 2003

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2002-D-0222
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is the second revision of Q1A Stability Testing of New Drug Substances and Products, which was first published in September 1994 and revised in August 2001. The purpose of this revision is to harmonize the intermediate storage condition for zones I and II with the long-term condition for zones III and IV recommended in the ICH guidance Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV. The changes made in this second revision are listed in the attachment to this guidance.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2002-D-0222.

 
Back to Top