FDA Issues Final Report on 21st Century cGMPs

09/30/2004

On September 29, the FDA issued the final report detailing its initiative to modernize the regulations that govern drug manufacturing. The report, “Pharmaceutical cGMPs for the 21^st Century—a Risk-Based Approach,” comes two years after the Agency announced its intentions to update its guidelines and regulatory system. It is available at http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm.

While the “final” report remains a work in progress, with many of its key elements under continued review and in draft form, it is nonetheless a milestone for the Agency and industry. “This 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,” said Health and Human Services Secretary Tommy Thompson.

Following the announcement, John Taylor, FDA associate commissioner for regulatory affairs, reiterated the initiative’s ongoing goals: to stay focused on practices that minimize risks to public health; to ensure that the FDA encourages rather than impedes pharmaceutical innovation; and to further coordinate the Agency’s own internal efforts as well as harmonize efforts with regulatory bodies worldwide.

Several new wrinkles to the cGMP guidelines were made public. Among them, the Agency has formed a Council on Pharmaceutical Quality, which will be responsible for continued policy development and change management. The FDA also said that it will replace the current chemistry, manufacturing and controls (CMC) system in favor of a yet-to-be-established risk-based pharmaceutical quality assessment system.

In conjunction with the report, the FDA announced that several anticipated documents are now available, including:

• Final guidance on process analytical technology: “PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance” http://www.fda.gov/cder/guidance/6419fnl.htm;
  
• Final guidance on aseptic processing used in the manufacturing of sterile drugs http://www.fda.gov/cder/guidance/5882fnl.htm;
  
• Draft guidance on good manufacturing practices for combination products (such as drug and device pairings) http://www.fda.gov/cder/guidance/OCLove1dft.htm;
  
• A white paper titled, “Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites — A Pilot Risk Ranking Model” http://www.fda.gov/cder/gmp/gmp2004/risk_based_method.htm.