by Joseph X. Phillips 

Two years ago, the U.S. Food and Drug Administration launched its new initiative, Pharmaceutical cGMPs for the 21st Century -- A Risk-Based Approach. The Agency outlined several objectives:

• To encourage the early adoption of new technological advances by the pharmaceutical industry.
• To facilitate industry application of modern quality management techniques.
• To encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas.
• To ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science.
• To enhance the consistency and coordination of FDA's drug regulatory programs.

Among the many specific undertakings, the Agency is encouraging the industry to adopt PAT (Process Analytical Technology) principles. PAT is a framework for innovative pharmaceutical manufacturing and quality assurance. Through PAT, the Agency is encouraging firms to know their processes and to employ risk-based management techniques.

The Agency has been actively working on these initiatives and is closely monitoring and reporting on its accomplishments – and the initiatives have been well-received by stakeholders.

ISPE feels that the new initiatives provide abundant opportunities for our industry to improve processes and quality while potentially reducing costs. Likewise, the new initiatives offer the Society many new opportunities to serve our members into the 21st century.

ISPE has a long and proud history of working with industry, academia and regulators to facilitate change when desirable. It was a distinct honor to be approached by the FDA and asked to be a “catalyst for change” to help implement some of the initiatives outlined in the guidance. For example, we are involved in the following areas:

• Helping pharmaceutical engineers develop the additional skill sets they need for the future. We have facilitated industry, academia and FDA getting together on a Webinar to "brainstorm" educational needs for the future. This will be followed up by additional focused Webinars to bring the stakeholders together for further development of educational programs. This Agency effort is being fully supported by ISPE’s International Leadership Forum.
• Helping disseminate the PAT Guidance information globally. Over the next three months, FDA and ISPE are co-sponsoring four international PAT Forums: Arlington, Virginia on 16 November; Tokyo, Japan on 8 December; Brussels, Belgium on 22 February; and Mumbai, India on 25 February. In addition, we are planning numerous PAT educational sessions in 2005.
• Certification of Individuals. ISPE is moving ahead with plans to develop a certification program for our Members.
• Working with pharmaceutical equipment manufacturers. We are examining ways to work with equipment manufacturers and users to make the issues of IQ and OQ less burdensome and more efficient. This effort is being supported by our International Leadership Forum, which is working on a pilot model.

The above are just a few examples of areas in which ISPE is making a difference!

About the Author
Joseph X. Phillips joined ISPE in 2003 as Regulatory Affairs Advisor and was appointed to the US Food and Drug Administration (FDA) as a special government employee on the Pharmaceutical Science Advisory Committee that is involved in the agency’s new “Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century” initiative. Previously, Phillips was Vice President, Pharmaceutical Services for Quintiles Consulting following a 44-year career with the FDA. At the FDA he served as Deputy Regional Director of the Agency’s Central Region. He was heavily involved in training of FDA Investigators and in planning and managing pharmaceutical programs including the Pre-Approval Inspection program and the SUPAC (Scale-Up and Post Approval Changes) for field operations. Phillips was a principal negotiator for the US/EU Mutual Recognition Agreement and was the FDA Lead to the International Conference on Harmonization (ICH) Expert Working Group for GMP Guidance for Active Pharmaceutical Ingredients (ICH Q7A Guidance)