Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach, Final Report 2004

In September 2004, FDA released its final report on achievements and future plans of the initiative known as the "Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach." Sixteen multi-disciplinary groups comprising scientific and regulatory practice experts from the Center for Drug Evaluation and Review (CDER), the Center for Biologics Evaluation and Review (CBER), the Center for Veterinary Medicines (CVM), the Office of Regulatory Affairs (ORA) and the Office of the Commissioner (OC) within FDA shaped and implemented the initiative under the oversight of the CGMP Steering Committee. Their findings put the agency on a path to develop a product quality regulatory system for the future by creating a system intended to streamline the quality review of pharmaceutical products. This system would allow FDA to use its resources in a more efficient manner while retaining flexibility to accommodate complex products.

Participating groups envisioned a highly educated, well-trained, integrated team of individuals throughout FDA who would use risk-based and science-based approaches for regulatory decision-making throughout the entire life cycle of a product. To move toward this new system, the agency established the Council on Pharmaceutical Quality (CPQ) and charged it with policy development, coordination, and continuing change management, including the ongoing implementation of certain quality management systems within FDA. Key accomplishments of the council were announced in the 2004 final report, including:

• Adoption of a quality systems model for agency operation, developed under FDA's Management Council and published in the FDA Staff Manual Guide. The guide defines the essential quality elements to consider as part of any system that controls an internal FDA regulatory activity.
• Development of a quality systems guidance for CGMP regulation. The draft guidance for industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, is intended to encourage industry to implement the use of quality-management systems and risk-management principles. The guidance explains how manufacturers implementing a comprehensive quality system can ensure full compliance with CGMP regulations (21 CFR Parts 210 and 211).
• Adoption of risk-management principles to enhance the agency's inspection and enforcement program, which is focused on protecting the public health. For example, FDA began using a risk-based approach for prioritizing domestic manufacturing site inspections for certain human pharmaceuticals. This approach will help the agency predict where its inspections are likely to achieve the greatest public health impact.
• Establishment of a new risk-based pharmaceutical quality assessment system to replace the CMC review system in the Office of New Drug Chemistry within CDER. The new assessment system has the potential to reduce the regulatory burden in proportion to the manufacturer's efforts to achieve continuous improvement and manufacturing process optimization.
• Development of several science-based guidances for industry (e.g., PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance; Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice; and Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP). In addition, training programs to support risk-based regulatory decisions and continuous improvement in pharmaceutical manufacturing were established.