[Federal Register: September 5, 2003 (Volume 68, Number 172)]
[Notices]
[Page 52781-52782]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se03-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0380]
Draft Guidance for Industry: Process Analytical Technology -- A
Framework for Innovative Pharmaceutical Manufacturing and Quality
Assurance; 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availability of a draft guidance entitled ``Guidance for Industry: PAT
-- A Framework for Innovative Pharmaceutical Manufacturing and Quality
Assurance.'' The draft guidance explains a science-based, risk-based
framework, ``Process Analytical Technology, or PAT,'' for developing
and implementing innovative manufacturing technology. The guidance is
intended to encourage innovative pharmaceutical manufacturing and
quality assurance. Working with existing regulations, this guidance
also describes a regulatory approach that will enable the agency and
the pharmaceutical industry to address technical and regulatory issues
and questions anticipated during introduction of new manufacturing and
quality assurance technologies.
DATES: Submit written or electronic comments on this draft guidance on
paper or electronically, by November 4, 2003. General comments on
agency guidance documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the draft guidance to the Divison of Dockets Management (HFA-305),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.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Rajendra Uppoor, Center For Drug Evaluation and Research (HFD-003),
5600 Fishers Lane, Rockville, MD 20857, 301-594-5615, or
Dennis Bensley, Center for Veterinary Medicine (HFV-143), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-
6956, or
Robert Coleman, Office of Regulatory Affairs, Food and Drug
Administration, 60 8th Street North East, Atlanta, GA 30309, 404-253-
1200, ext. 1295.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance entitled ``Guidance for Industry: PAT -- A Framework for
Innovative Pharmaceutical Manufacturing and Quality Assurance.'' The
draft guidance explains a science-based, risk-based framework,
``Process Analytical Technology, or PAT,'' for developing and
implementing innovative manufacturing technology. The guidance is
intended to encourage innovative pharmaceutical manufacturing and
quality assurance.
I. Background
Conventional pharmaceutical manufacturing is generally accomplished
using batch processing with testing conducted on collected samples to
ensure quality. This conventional approach has been successful in
providing quality pharmaceuticals to the public. However, significant
opportunities now exist for improving the efficiency of pharmaceutical
manufacturing and quality assurance through the innovative application
of modern process development and control technologies, including
modern PAT. Unfortunately, the pharmaceutical industry generally has
been hesitant to introduce new technologies and innovative systems into
the manufacturing sector for a number of reasons. For example, one
reason often cited is regulatory uncertainty, which may result from the
perception that our existing regulatory system is unfavorable to the
introduction of new technologies.
In August 2002, recognizing the need to free industry from its
hesitant perspective, FDA launched a new initiative entitled
``Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach.''
Pharmaceutical development and manufacturing is evolving with
increased emphasis on science and engineering principles. Effective use
of pharmaceutical science and engineering principles and knowledge,
throughout the life cycle of a product, can improve the efficiencies of
both manufacturing and regulatory processes. FDA's initiative is
designed to do just that using an integrated systems approach to
regulating pharmaceutical product quality. This approach is based on
science and engineering principles for assessing and mitigating risks
related to poor product and process quality. The desired future state
of pharmaceutical manufacturing may be characterized as: (1) Product
quality and performance achieved and ensured through the design of
effective and efficient manufacturing processes, (2) product and
process specifications based on a mechanistic understanding of how
formulation and process factors affect product performance, (3)
continuous real time quality assurance, (4) regulatory policies and
procedures tailored to recognize the level of scientific knowledge
supporting products and processes, (5) risk-based regulatory approaches
that recognize the
[[Page 52782]]
level of scientific understanding of how formulation and manufacturing
process factors affect product quality and performance and the
capability of process control strategies to prevent or mitigate the
risk of producing a poor quality product. This draft guidance is part
of this initiative and is intended to facilitate progress to this
desired state.
The 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 this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. You can use an alternative
approach if the approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit
written or electronic comments to ensure adequate consideration in
preparation of the final guidance. 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 the brackets in the heading of this
document. A copy of the draft guidance and received comments are
available for public examination 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 draft guidance
at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
Dated: August 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-22578 Filed 9-3-03; 10:00 am]
BILLING CODE 4160-01-S