The systems approach is much more than a force-multiplier for FDA. It is a tool companies can use to their advantage. The
systems paradigm is a way of thinking about the strategic environment — how to develop processes that achieve strategic goals.
Forward-thinking organizations can use it to strategically analyze and respond tactically to changes in the business and regulatory
environments by sustaining an adaptive and productive organizational culture.
A hunger for knowledge about quality systems and how to consistently apply and implement them exists within both FDA and industry.
Existing regulations are antiquated. The bar has been raised, as evidenced by inspectional findings, regulatory actions, and
penalties. Although the 1978 GMP rule does not require quality systems, CDER's compliance program mentions quality systems
and investigators expect industry to have them.
Many companies do not have quality systems in place because they are not required by regulations. However, the pharmaceutical
industry needs these programs to ensure consistency and high-quality products. Regulatory agencies should be able to evaluate
a firm's quality systems and determine compliance through a process of synthesis rather than analysis. FDA should not have
to weed through weeks of data on a specific topic — review of the system governing that data should allow quick determination
of control, adequacy, and compliance.
Management is the critical component in a quality system. Management mandates the need and design of quality systems and is
ultimately held accountable for reviewing outcomes and supporting corrective action.
A quality management team (QMT) is necessary and should consist of the highest level of management possible at a manufacturing
site with accountability and the resources needed to affect change. The QMT should be the governance vehicle that supports
the execution of a quality plan. The quality plan must encompass all the systems, as well as metrics, organizational needs,
corrective action procedures, and resource support.
FDA often cites a process, piece of equipment, or documented practice as unacceptable. Usually, it is not until a warning
letter or consent decree appears that management is cited, at which point it is too late.
Without key management taking action through the QMT, the quality plan and subsequent efforts are diminished, and results
may falter. The QMT provides a forum for discussion and support of the quality plan and ensures it is regularly reviewed,
updated, and executed, and it is a living document driving closure to notated issues and process and system improvements.
The new FDA initiatives outlined in this article will provide the basis for compliance programs into the future. In the face
of new threats and constraints, FDA continues to update and reinvent its regulatory strategy to ensure a safe and efficacious
supply of pharmaceutical products. Successful enterprises will acknowledge these changes quickly, to survive and thrive in
the current environment. GMP compliance — and implementation of the quality systems that support compliance — is the foundation
of the pharmaceutical industry and the benchmark of success for enterprises involved in the development, manufacture, or testing
of human and animal drug products.
Note: Additional information on guidance documents, "Pharmaceutical cGMPs for the 21st Century," and other FDA initiatives can
be found at
1. Arling E. Integrating QSIT into quality plans... Biopharm International 2004; 17(6):44-46,48,50-52.
2. Horowitz D. A risk based framework for GMP regulatory oversight. Presented at GMP by the Sea; 2004 Aug 24; Cambridge, Maryland.
3. Woodcock J. Keynote address. Presented at Interphex; 2004 March 16; New York, New York.
4. FDA. Draft guidance for industry: quality systems approach to pharmaceutical current good manufacturing practice regulations.
Available at www.fda.gov/cder/guidance/6452dft.htm.
Edward Arling is associate director of quality assurance at Amgen Inc.,
4000 Nelson Road AC22A, Longmont, CO 80503, 303.401.7860,
fax 303.401.7603, firstname.lastname@example.org