Document ID: FDA-2008-D-0559-0040
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Process Validation: General Principles and Practices; Reopening of Comment Period
Posted Date: 2009-02-13T05:00Z

[Federal Register: February 13, 2009 (Volume 74, Number 29)]
[Notices]               
[Page 7237-7238]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe09-48]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0559]

 
Draft Guidance for Industry on Process Validation: General 
Principles and Practices; Reopening of Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of comment period.

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SUMMARY:  The Food and Drug Administration (FDA) is reopening until 
March 16, 2009, the comment period for the draft guidance entitled 
``Process Validation: General Principles and Practices.'' FDA announced 
the availability of this draft guidance in the Federal Register of 
November 18, 2008 (73 FR 68431). The initial comment period closes on 
January 20, 2009. FDA

[[Page 7238]]

is taking this action in response to a request for an extension of the 
comment period, due to the holiday season, to allow interested persons 
sufficient time to review this draft guidance and submit comments.

DATES:  Submit written or electronic comments by March 16, 2009.

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

FOR FURTHER INFORMATION CONTACT:
    Brian Hasselbalch, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 
rm. 4364, Silver Spring, MD 20993-0002, 301-796-3279; or
    Grace McNally, Center for Drug Evaluation and Research (HFD-320), 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 
4374, Silver Spring, MD 20993-0002, 301-796-3286; or
    Christopher Joneckis, Center for Biologics Evaluation and Research 
(HFM-1), Food and Drug Administration, 5515 Security Lane, rm. 7302, 
Rockville, MD 20852, 301-435-5681; or
    Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8268.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is extending the comment period on a draft guidance for 
industry entitled ``Process Validation: General Principles and 
Practices.'' This guidance outlines the general principles and 
approaches that FDA considers to be appropriate elements of process 
validation for the manufacture of human and animal drug and biological 
products, including active pharmaceutical ingredients (API or drug 
substance). This guidance incorporates principles and approaches that 
all manufacturers can use in validating a manufacturing process.
    FDA issued the draft guidance on November 18, 2008. The initial 
comment period closes on January 20, 2009. In response to a request for 
an extension, due to the holiday season, to allow interested persons 
sufficient time to review this draft guidance and submit comments, FDA 
has decided to reopen the comment period until March 16, 2009.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/
guidelines.htm, http://www.fda.gov/cvm/guidance/published.htm, or 
http://www.regulations.gov.

    Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3090 Filed 2-12-09; 8:45 am]

BILLING CODE 4160-01-S