[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4360-4361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry on Process Validation: General Principles 
and Practices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 4361]]

availability of a guidance for industry entitled ``Process Validation: 
General Principles and Practices.'' This guidance provides information 
for the pharmaceutical industry on the elements of process validation 
for the manufacture of human and animal drug and biological products, 
including active pharmaceutical ingredients (APIs). The guidance is 
intended to provide clear and consistent communication of regulatory 
expectations and to promote voluntary compliance with current FDA 
requirements. This guidance revises and replaces the guidance for 
industry entitled ``Guideline on General Principles of Process 
Validation,'' dated May 1987.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit electronic comments on the 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: 
Brian Hasselbalch, Center for Drug Evaluation and Research, 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, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4374, Silver 
Spring, MD 20993-0002, 301-796-3286; 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; 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 announcing the availability of a guidance for industry 
entitled ``Process Validation: General Principles and Practices.'' This 
guidance document provides guidance to the pharmaceutical industry on 
the elements of process validation for the manufacture of human and 
animal drug and biological products, including APIs.
    This guidance describes process validation activities in three 
stages:
     In Stage 1, Process Design, the commercial process is 
defined based on knowledge gained through development and scale-up 
activities.
     In Stage 2, Process Qualification, the process design is 
evaluated and assessed to determine if the process is capable of 
reproducible commercial manufacturing.
     In Stage 3, Continued Process Verification, ongoing 
assurance is gained during routine production that the process remains 
in a state of control.
    In addition to discussing activities typical of each stage of 
process validation, the guidance provides recommendations regarding 
appropriate documentation and analytical methods to be used during 
process validation.
    In the Federal Register of November 18, 2008 (73 FR 68431), FDA 
announced the availability of a draft guidance of the same title and 
gave interested persons the opportunity to submit comments by January 
20, 2009. In the Federal Register of February 13, 2009 (74 FR 7237), 
the Agency reopened the comment period to March 16, 2009. The Agency 
received public comments from a broad spectrum of the pharmaceutical 
industry. In response to comments received on the draft guidance, the 
Agency added a glossary of terms and clarified or added more specific 
guidance on certain issues.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on the general principles and practices of 
process 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. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions 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 requested in the guidance are covered under 
FDA regulations at 21 CFR part 211, 21 CFR 314.70, and 21 CFR 601.12 
and are approved under OMB control numbers 0910-0139, 0910-0001 and 
0910-0338, respectively.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

IV. Electronic Access

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

    Dated: January 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1437 Filed 1-24-11; 8:45 am]
BILLING CODE 4160-01-P