[Federal Register: October 4, 2004 (Volume 69, Number 191)]
[Notices]
[Page 59257-59258]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc04-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0380]
Guidance for Industry: Process Analytical Technology--A Framework
for Innovative Pharmaceutical Development, 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 guidance entitled ``Guidance for Industry: PAT--A
Framework for Innovative Pharmaceutical Development, Manufacturing, and
Quality Assurance.'' The guidance explains a science-based, risk-based
framework, ``Process Analytical Technology, or PAT,'' to support
innovation and efficiency in pharmaceutical development, manufacturing,
and quality assurance. This framework is founded on process
understanding, with the goal of facilitating innovation and risk-based
regulatory decisions by industry and the agency. Working with existing
regulations, this guidance describes a regulatory approach that will
enable the agency and the pharmaceutical industry to address technical
and regulatory issues and questions anticipated during the
implementation of PAT.
DATES: General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the 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. Send one self-addressed adhesive label to assist
that office in processing your requests. Submit written comments on the
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.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT:
Chris Watts, Center For Drug Evaluation and Research (HFD-003),
5600 Fishers Lane, Rockville, MD 20857, 301-443-5197; 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 (HFR-SE150), Food and
Drug Administration, 60 8th St. North East Atlanta, GA 30309, 404-253-
1200, ext. 1295.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled
``Guidance for Industry: PAT--A Framework for Innovative Pharmaceutical
Development, Manufacturing, and Quality Assurance.'' The guidance
explains a science-based, risk-based framework, ``Process Analytical
Technology, or PAT,'' that supports innovation and efficiency in
pharmaceutical development, manufacturing, and quality assurance. The
framework is founded on process understanding, which can be used to
facilitate innovation and risk based regulatory decisions by industry
and the agency.
Conventional pharmaceutical manufacturing is generally accomplished
using batch processing with laboratory testing conducted on collected
samples to evaluate quality. This conventional approach has been
successful in providing quality pharmaceuticals to the public. However,
today significant opportunities exist for improving pharmaceutical
development, manufacturing, and quality assurance through innovation in
product and process development, process analysis, and process control.
Unfortunately, the pharmaceutical industry generally has been hesitant
to introduce innovative systems into the manufacturing sector for a
number of reasons. One reason often cited is regulatory uncertainty,
which may result from the perception that the existing regulatory
system is rigid and unfavorable to the introduction of innovative
systems. In August 2002, recognizing the need to eliminate the
hesitancy to innovate, FDA launched a new initiative entitled
``Pharmaceutical Current Good Manufacturing Practices for the 21st
Century: A Risk-Based Approach.'' Development of this guidance was part
of that initiative.
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 the following:
(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 level of scientific understanding of how formulation
and manufacturing process factors affect product quality and
performance, as well as, the capability of process control strategies
to prevent or mitigate the risk of producing a poor quality product.
This guidance is intended to facilitate progress to this desired state.
II. Comments Received on the Draft Guidance
In the Federal Register of September 5, 2003 (68 FR 52781), FDA
published a document announcing the availability of a draft version of
this guidance. The draft guidance was issued with the goal of
soliciting comments from the public on related issues. The agency
received a number of comments on the draft guidance, and those comments
were considered carefully as the guidance was finalized. A number of
changes were made to the guidance. Most of them were of an editorial
nature. The following three substantive changes were made to the
guidance as a result of the comments: (1) The scope of the guidance was
expanded to include the Center for Drug Evaluation and Research's
Office of Biotechnology Products, (2) links were established to ASTM
Technical Committee E55 entitled ``Pharmaceutical Application of
Process Analytical Technology,'' and (3) the section on process
understanding was moved forward to emphasize the guidance's focus.
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 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. An alternative
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approach may be used if the approach satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons with access to the Internet may obtain the 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: September 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22203 Filed 9-29-04; 1:51 pm]
BILLING CODE 4160-01-S