Charter of the
Council on Pharmaceutical Quality
(An FDA Management Council Subcommittee)
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To facilitate FDA’s modernization of the regulation of
pharmaceutical manufacturing and product quality, the FDA Management Council
establishes a Council on Pharmaceutical Quality (herein referred to as Council).
This charter describes the duties and responsibilities of the Council, the
organization of its membership, and its operating procedures. This charter
also sets forth information on the roles and responsibilities of expert working
groups deemed necessary by the Council to accomplish the goals and objectives
it establishes.
2.
BACKGROUND
More than 40 years ago, Congress
required that all drugs must be produced in accordance with Current Good
Manufacturing Practice (CGMP). This requirement was intended to address
significant concerns about substandard drug manufacturing practices by applying
quality assurance and quality control principles to drug manufacturing. The
last comprehensive revisions to the regulations implementing CGMP requirements
occurred almost 25 years ago. In addition, pre-market approval requirements to
ensure the quality of approved drugs pertaining to chemistry and manufacturing
controls, have also been in effect for many years.
As the 25th
anniversary of the last major revisions to the drug CGMP regulations
approached, the Agency believed that it needed to step back and evaluate the
currency of both the CGMP program and the pre-market review of chemistry and
manufacturing issues. In August 2002, FDA announced its undertaking of a
significant new two-year long initiative to enhance the regulation of
pharmaceutical manufacturing and product quality and to bring a 21st century
focus to this FDA responsibility. The initiative was intended to build on the
many successes of the inspection and review programs and help them continue to
be successful in the future by keeping pace with advances in pharmaceutical
science and manufacturing technologies.
The initiative known as Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach, focused
on FDA's current good manufacturing practice (CGMP) program, the scope of which
included veterinary drugs and human drugs, and select human biological drug
products such as recombinant therapeutics and vaccines.
It was designed to improve
public health promotion and protection by focusing on three major goals
intended to augment FDA's pharmaceutical product quality assurance programs
across the board.
The first goal intended to enhance the focus of the agency's CGMP
requirements more squarely on potential risks to public health, by providing
additional regulatory attention and agency resources on those aspects of
manufacturing that pose the greatest potential risk.
FDA’s product quality regulatory system was established many
decades ago, with incremental adjustments occurring over the years. However,
significant changes in the pharmaceutical environment have occurred in the last
several decades that warranted a systematic reappraisal of FDA’s approaches to
product quality regulation. These changes include: more approved medicines
that have a greater role in healthcare, advances in pharmaceutical sciences and
manufacturing technologies, advances in science and management of quality,
application of biotechnology and globalization of industry. However, due to
resource constraints, FDA’s capacity to conduct on-site inspections of
manufacturing sites for many human drugs and its compliance policies have not
kept pace with the changes. Therefore, the agency has reappraised its product
quality regulatory system so that it can do its job better in the face of
stagnant or diminishing resources. The principles that guided the
implementation of the reappraisal include a more systematic and rigorous
risk-based orientation; regulation based on all applicable science;
international cooperation; strengthening of public health protection; and
coordinating and adapting a quality system that establishes core quality
requirements for all regulated medical products.
¨ The second goal intended to help ensure that FDA's essential work
in establishing and enforcing pharmaceutical product quality standards does not
impede innovation and the introduction of new manufacturing technologies in the
pharmaceutical industry.
¨ The third goal was implemented to
enhance the consistency and predictability of FDA's approach among the FDA's
centers and field components.
The initiative sought to better integrate quality systems
and risk management approaches into the existing programs and encourage industry
adoption of modern and innovative manufacturing technology. The initiative
also intended to enhance the integration of the pre-approval review and CGMP
programs and achieve more consistent application across agency organizational
components. In addition, the initiative utilized existing and emerging science
and analysis to ensure that limited resources are best targeted to address
important quality issues, especially those associated with predicted or
identifiable health risks.
The Initiative has been
overseen by a steering committee with representation from the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation and Research, the
Center for Veterinary Medicine, the Office of Regulatory Affairs and the Office
of the Commissioner. Over the life of the initiative, the steering committee
has established working groups comprised of agency experts from various areas
of scientific and regulatory practice. These groups have shaped and
implemented the initiative to achieve the goals and objectives outlined at the
onset.
Although there have been significant accomplishments in two years, there
are goals that have been identified but have not yet been fully achieved and
new challenges are likely to arise. In order to continue the progress that has
been made during the CGMP Initiative, as well as stay abreast of continuing
advances in technology and improve our understanding of the elements that
constitute good quality and the needs of both the review and GMP programs to
support this, it is necessary to establish a Council on Pharmaceutical Quality,
a subcommittee to the FDA Management Council.
5.
PROCEDURES
5.1
In performing these
responsibilities, the Council will:
a). Oversee the preparation of documents
intended to communicate and implement consistent, standard policies and
procedures related to quality system design and implementation for internal and
external use;
b). Facilitate public discussion and input to
cross-cutting GMP issues, including policy, science and technology aspects;
c). Establish and oversee work groups for the
purposes of fulfilling the Council’s responsibilities;
d). Review and concur with work products (e.g.
documents or recommendations) of the work groups before they are circulated for
FDA Management Council concurrence;
e). Communicate recommendations, decisions and
actions to FDA Management Council, senior management, staff and other
interested parties;
f). Provide input and work with other
committees or agency components as necessary on matters which may impact or
intersect with the established goals and objectives;
g). Develop and have approved by the FDA Management
Council a work plan to achieve the goals and responsibilities of the Council.
Major alterations to the work plan should be approved by the Management
Council.
6.
RECORDS
August 21, 2002 Concept Paper: Pharmaceutical cGMPs for the 21st
Century: A Risk-Based Approach (A science and risk-based approach to product
quality regulation incorporating an integrated quality systems approach)
February 20, 2003: Summary Progress Report
September 3, 2003: Pharmaceutical CGMPs for the 21st century — A
Risk-Based Approach, Second Progress Report and Implementation Plan
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Date created: September 29, 2004 |