1.2: Manufacturing, Processing, and Distribution Oversight

Provide high quality, cost-effective oversight of industry manufacturing, processing and distribution to reduce risk.

Other Information:

Apply the most current scientific knowledge about risk management and quality assurance to the FDA's requirements, including Current Good Manufacturing Practice (CGMP) inspection, compliance, and enforcement activities. Develop new inspection approaches to more effectively utilize new and existing resources. Implement an efficient, risk-based system to promote the wide availability of safe FDA-regulated imports by increasing the standards and improving the practices of source countries and at points of entry into U.S. commerce, improving detection of noncompliant products, and developing standards and procedures to maximize the cost-effectiveness of agency oversight. Highlights for Objective 2 The FDA oversees the quality of drug products through 1) the review of information in product applications and 2) inspection of manufacturing facilities. This approach has protected consumers for over 25 years, yet the FDA plans to make sure it is up-to-date. Enhance expertise by training staff on new scientific approaches and innovative pharmaceutical manufacturing technologies. Publish guidance on 21 CFR Part 11 to clarify scope, requirements and application. Evaluate mechanisms to communicate deficiencies to industry, including content, consistency, disclosure, and education. Use emerging science and data analysis to target the highest risk areas. Educate industry on new regulatory approaches that encourage innovation.

Indicator(s):

Indicator:1

Content