[Federal Register: November 18, 2008 (Volume 73, Number 223)]
[Notices]
[Page 68431-68432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no08-88]
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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Draft Guidance for Industry on Process Validation: General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; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Process
Validation: General Principles and Practices.'' FDA is revising its
guidance for industry entitled ``Guideline on General Principles of
Process Validation,'' which issued in May 1987 (the 1987 guidance). The
revised draft guidance promotes a ``lifecycle'' approach to process
validation that includes scientifically sound design practices, robust
qualification, and process verification. When finalized, this draft
guidance will replace the 1987 guidance.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by January 20, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448; or to the Communications Staff (HFV-12), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800.
Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
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;
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, 301-301-796-3286;
Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-1), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-0373; or
Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6956.
SUPPLEMENTARY INFORMATION:
[[Page 68432]]
I. Background
FDA is announcing the availability of 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.
In the Federal Register of May 11, 1987 (52 FR 17638), FDA issued a
notice announcing the availability of a guidance entitled ``Guideline
on General Principles of Process Validation'' (the 1987 guidance).
Since then, we have obtained additional experience through our
regulatory oversight that allows us to update our recommendations to
industry on this topic. The draft guidance conveys FDA's current
thinking on process validation and is consistent with basic principles
first introduced in the 1987 guidance. The draft guidance also provides
recommendations that reflect some of the goals of FDA's initiative
entitled ``Pharmaceutical CGMPs for the 21st Century--A Risk-Based
Approach,'' particularly with regard to the use of technological
advances in pharmaceutical manufacturing, as well as implementation of
modern risk management and quality system tools and concepts. When
finalized, this guidance will replace the 1987 guidance.
FDA's current good manufacturing practice (CGMP) regulations for
validating pharmaceutical (drug) manufacturing require that drug
products be produced with a high degree of assurance that they meet all
the attributes they are intended to possess (21 CFR 211.100(a) and
211.110(a)). Effective process validation contributes significantly to
the assurance of drug quality. FDA has the authority and responsibility
to inspect and evaluate process validation performed by manufacturers.
This guidance aligns process validation activities with the product
lifecycle concept and with existing FDA guidance, including
International Conference on Harmonisation (ICH) guidance documents,
``Q8 Pharmaceutical Development,'' ``Q9 Quality Risk Management,'' and
when it is finalized, ``Q10 Pharmaceutical Quality System'' (a notice
of availability for the May 2007 ICH Q10 draft guidance published in
the Federal Register on July 13, 2007 (72 FR 38604)) (the guidances are
available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm). The lifecycle concept links product and process
development, qualification of the commercial manufacturing process, and
maintenance of the process in a state of control during routine
commercial production. This guidance promotes modern manufacturing
principles, process improvement innovation, and sound science.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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 draft 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
collection of information requested in the draft guidance is covered
under FDA regulations at 21 CFR part 211, and is approved under OMB
Control Number 0910-0139.
III. 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/guidance/published.htm, or
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Dated: November 10, 2008.
Jeffery Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27321 Filed 11-17-08; 8:45 am]
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