[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