FDA News
FOR IMMEDIATE RELEASE
P04-93
September 29, 2004
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FDA Issues Final Report
on Its “21 st Century” Initiative on the Regulation of Pharmaceutical
Manufacturing
Following the second anniversary of the launch of its Pharmaceutical Manufacturing
Initiative, the Food and Drug Administration (FDA) today issued a final report
that highlights specific steps the agency has taken and will take to develop
and implement quality systems management and a risk-based product quality regulatory
system.
The report describes the accomplishments and plans for the future resulting
from FDA’s completed assessment of the current good manufacturing practice
(CGMP) regulations, current practices, and the new tools in manufacturing science
that will enable a progression to controls based on quality systems and risk
management.
“Americans must have confidence in the quality of their medications
even as we face more sophisticated technology and manufacturing processes,” HHS
Secretary Thompson said. “This final report provides clear guidance for
both FDA and manufacturers to implement a risk-based quality assessment system
that will ensure that the drug supply in the United States is of consistently
high quality.”
“The accomplishments and next steps announced demonstrate FDA’s
commitment and continued progress toward modernizing the regulation of manufacturing
and product quality for both human and veterinary drugs as well as biological
products,” said FDA Acting Commissioner Dr. Lester M. Crawford. “FDA’s
CGMP Steering Committee has completed its two-year assessment of existing CGMP
programs, and the agency has begun to implement a new scientific and risk-based
approach to pharmaceutical manufacturing and product quality.”
FDA’s initiative has focused on its current regulation of pharmaceutical
quality, encompassing veterinary and human drugs, and select human biological
drug products such as vaccines. The report issued today addresses FDA’s
findings, which put the agency on a path to develop the product quality regulatory
system of the future. The report describes specific steps the agency is taking
to achieve this system. Some of these include:
- The formation of a Council on Pharmaceutical Quality that will be charged
with policy development and continuing change management, including the ongoing
implementation of certain quality management systems within FDA relating
to pharmaceutical quality regulation;
- A first step in establishing a new risk-based pharmaceutical quality assessment
system is to replace the current chemistry, manufacturing and controls (CMC)
review system, in the Office of New Drug Chemistry within the Center for
Drug Evaluation and Research;
- The issuance of a draft guidance on the role of quality systems in the
pharmaceutical current good manufacturing practice regulations to ensure
agency regulatory practices encourage similar progress in the pharmaceutical
industry as well as enabling manufacturers to tailor their quality system
to fit their specific manufacturing environment;
- More systematic risk-based
approaches to inspectional oversight of pharmaceutical manufacturing, beginning
with pilot implementation of a risk-based model for prioritizing domestic
manufacturing sites for many human drug CGMP inspections;
- The issuance
of a final guidance on aseptic processing used in the manufacturing of
sterile drugs, encouraging the adoption of modern science and technology
and risk-based approaches;
- The issuance of a final guidance on Process Analytical
Technology (PAT) – a
framework for allowing regulatory processes to more readily adopt state-of-the-art
technological advances in drug development, production and quality;
- The
publishing of a draft guidance on good manufacturing practice for combination
products, (i.e., products combining components from two or more of these
regulatory categories: drug, device, or biological product);
- Continued
active collaboration with the International Conference on Harmonization
of the Technical Requirements for Registration of Pharmaceuticals (ICH) and
the International Cooperation on Harmonization of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH), leading to the
implementation of an internationally harmonized plan for a pharmaceutical
quality system based on an integrated approach to risk management and science;
and
- FDA’s decision to seek membership in the Pharmaceutical Inspection
Cooperation Scheme – a cooperative agreement among national health
regulatory authorities whose purpose includes leading international development,
implementation, and maintenance of harmonized CGMP standards and Quality
Systems of world-wide pharmaceutical inspectorates.
In addition, the following accomplishments underscore the agency’s
commitment to realizing the specific goals of this initiative:
- A proposed rule amending Part 11, Electronic Records, Electronic Signatures – Scope
and Application is expected to be published for public comment in
2005;
- A draft guidance on the use of computerized systems in clinical trials,
once finalized, will replace the guidance of the same name issued in April
1999;
- The implementation of a technical dispute resolution process for CGMP
disputes;
- The upcoming finalization of guidance on preparation and use of a comparability
protocol for assessing chemistry, manufacturing and control changes to chemical
entities, protein drug products and biological products;
- Improved integration of the preapproval and CGMP inspection programs through
training, certification, and Center detail opportunities for the 26 candidates,
who have just completed their first level of training, chosen for the Pharmaceutical
Inspectorate; and
- The implementation of a revised Charter by the Team Biologics Operations
Group that adopts a quality systems management framework, improves processes
for communication and coordination between headquarters and the district
offices, and further integrates product specialists into the program.
Making improvements in the way we regulate pharmaceutical manufacturing and
product quality is necessary to require the use of the best scientific data
available, to develop quality standards, and to use efficient systems and practices
that will provide clear and consistent decisions and communications for the
regulated industry and the American public.
The progress that is being made reflects the agency’s commitment to
the consistent adoption of risk management principles and a strong, robust
inspection and enforcement program centered on the protection of the public
health of all Americans.
More information on this major initiative, as well as the final report, is
available online at http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm
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