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Pharmaceutical cGMPs for the 21st Century:
A Risk-Based Approach
Progress Report on Process Analytical Technology
Comments on this report should be submitted to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All comments should be identified with Docket
Number 03N-0059.
Electronic
Management Comment Form: Docket 03N-0059 - Pharmaceutical Current
Good Manufacturing Practices for the 21st Century: A Risk-Based Approach
The FDA’s Process Analytical Technology (PAT) initiative is an
effort to facilitate the introduction of new manufacturing technologies
in the pharmaceutical industry for achieving more efficient processes.
Process Analytical Technologies are systems that enhance process
understanding and assist in identifying and controlling critical points
in a process. These include appropriate measurements devices, that can
be placed at/in- or on-line, statistical and information technology
tools, and a scientific systems approach for data analysis to control
processes to ensure production of in-process materials and final
products of desired quality.
FDA has actively involved stakeholders in the development of this
initiative through the FDA Science Board and the PAT Subcommittee of the
FDA's Advisory Committee for Pharmaceutical Science. Additionally, FDA
has sponsored conferences and meetings to disseminate agency thoughts on
PAT, as well as to gather and share information on various applications
of PAT from pharmaceutical and other industries. Additional information
on the PAT Initiative can be obtained from: http://www.fda.gov/cder/OPS/PAT.htm
To support PAT activities, FDA created:
- A PAT subcommittee composed of senior pharmaceutical and generic
manufacturers, government officials, and private and academic
pharmaceutical consultants. This subcommittee reported to FDA's
Advisory Committee for Pharmaceutical Science and assisted the
Agency in developing a general guidance for adoption of PAT by the
regulated industry.
- A Steering Committee comprised of senior managers in the FDA,
which oversees PAT activities for the Agency.
- A PAT Review, Inspection and OPS Policy Development Team (PATRIOT)
comprised of CMC reviewers, compliance officers and field
investigators. This team is being trained on PAT issues and new
technologies to manage the review/inspection process.
- A PAT Research Team in the Office of Testing and Research, which
conducts research to provide information for policy development.
Other Accomplishments:
- Building consensus within and outside the agency on PAT
applications and opportunities for improving the efficiency of
manufacturing and associated regulatory processes.
- Evaluated a "pro forma" submission from one company and
four other companies have expressed interest to discuss with FDA
their planned applications
- Successfully recruited three pharmaceutical/chemical engineers
with expertise in PAT
- Established and initiated a specialized training program for the
review-inspection team
- Organized several scientific workshops in US and Europe
- Initiated a research program on PAT and published one paper and
several presentations
Collaborative Research and Development Agreement with a major
pharmaceutical company on PAT applications developed and is currently
under review at the FDA
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Date created: February 27, 2003 |
