[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59257-59258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22203]



[[Page 59257]]

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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://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

[[Page 59258]]

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://www.fda.gov/cder/guidance/index.htm or 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