Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
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.
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: Process Analytical Technology - (PAT) Initiative.
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.
- 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