[Federal Register Volume 68, Number 172 (Friday, September 5, 2003)]
[Notices]
[Pages 52781-52782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22578]


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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Draft Guidance for Industry: Process Analytical Technology -- A 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availability of a draft guidance entitled ``Guidance for Industry: PAT 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 The draft guidance explains a science-based, risk-based 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DATES:  Submit written or electronic comments on this draft guidance on 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Divison of Dockets Management (HFA-305), 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://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access to the draft guidance document.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://www.fda.gov/cder/guidance/index.htm or 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