[Federal Register Volume 73, Number 223 (Tuesday, November 18, 2008)]
[Notices]
[Pages 68431-68432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27321]


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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Draft Guidance for Industry on Process Validation: General 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availability of a draft guidance for industry entitled ``Process 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revised draft guidance promotes a ``lifecycle'' approach to process 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 When finalized, this draft 
guidance will replace the 1987 guidance.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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 The draft guidance may also be 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Submit written comments on the draft guidance to the Division of 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://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://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://www.regulations.gov.

IV. 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: 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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