Process Analytical Technologies (PAT)
The Process Analytical or PAT initiative is defined as a system for designing, analyzing and controlling manufacturing through timely measurements on the basis of ensuring that quality is ‘built-in’ to the design with the goal of ensuring final product quality. The scientific, risk-based framework outlined in the guidance, Process Analytical Technology or PAT, should help developers and manufacturers implement new efficient tools for use during pharmaceutical development, manufacturing, and quality assurance while maintaining or improving the current level of product quality assurance. The framework includes two components: (1) a set of scientific principles and tools supporting innovation and (2) a strategy for regulatory implementation that will accommodate innovation. The goal of PAT is to encourage developers and manufacturers to take advantage of innovative technological advances in pharmaceutical development, manufacturing and quality assurance, and to improve manufacturing efficiency.
Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and QualityAssurance – This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It is intended to describe a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical development,manufacturing and quality assurance (September 2004).
21st Century Initiative
FDA issued a final report on Its 21st Century Initiative on the Regulation of Pharmaceutical Manufacturing. The final report highlights the specific steps required to develop and implement quality systems management and a risk-based product quality regulatory system.
The report describes the accomplishments and plans for the future resulting from FDA’s completed assessment of the current good manufacturing practice (CGMP) regulations, current practices, and new tools in manufacturing science that will enable a progression based on quality systems and risk management. To view and download the report, click here.
Bioterrorism Response Act
Invensys Validation Technologies offers Solutions designed to respond to the "Public Health Security and Bioterrorism Preparedness and Response Act" of 2002. This U.S. Act requires the U.S. Food and Drug Administration (FDA) to enact and enforce regulations to protect the food supply in the event of terrorist attack. It means that every food-processing company in the United States (excluding farms and restaurants) is required to follow its regulations which ensure that security and traceability and ultimately prevent fraud.
Invensys Solutions assist food-processing and pharmaceutical companies to address the reporting requirement of the Act and the FDA regulations.
