FDA ISSUES GUIDANCE ON EFFICIENT DRUG MANUFACTURING

The FDA is seeking to help the pharma industry adopt modern quality management system principles so that companies can produce drugs more efficiently, lower costs and prevent shortages through a new guidance released Sept. 29. The document is meant to "foster innovation and continuous improvements in pharmaceutical manufacturing," the agency said.

The guidance, titled "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations," brings up to date the agency's thinking on advances in the quality and manufacturing sciences since the current good manufacturing practice (cGMP) regulations were issued in 1978. The document describes the key elements of a robust quality systems model and shows how it can be used to achieve compliance with the cGMP regulations. It is part of the agency's Critical Path Initiative, which seeks to modernize the development of new drugs.

Issues the agency's "quality systems working group" identified in August 2002 to be addressed in the guidance include:The rising number of pharmaceutical products; The increasing role of medicines in healthcare; The declining frequency of FDA manufacturing inspections due to lack of resources; The FDA's increasing experience with and ability to learn from various approaches to product quality regulation; Advances in the pharmaceutical sciences and manufacturing technologies; The increasing application of biotechnology to drug discovery and manufacturing; Advances in the science and management of quality; and The globalization of the pharmaceutical industry.

The guidance reflects the FDA's risk- and science-based approach and its push for integrated quality systems and international cooperation, while keeping protection of public health at the top of the agenda.