!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 9: Quality Unit (Site) Management Regulations define the quality unit (QU) as the concept that is consistent with modern quality systems in…
Integration into Industry and Regulatory Operations Quality risk management is the foundation for science-based decisions when integrated into a quality management system (QMS). It does not obviate industry’s obligations…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 5: Enforcement Actions Pharmaceutical companies and the regulatory agencies that provide oversight for their activities share a responsibility for ensuring the manufacture…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 4: Regulatory Inspections Inspection Authority The Food, Drug, and Cosmetic Act (FDCA) grants the United States Food and Drug Administration (FDA) the…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 2: Regulations and Guidances It is necessary to possess the ability to interpret regulations and guidelines as published or administered by the…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 3: Mutual Recognition Agreements Mutual Recognition Agreements Mutual recognition agreements (MRA) are international agreements that specify the conditions under which the participating…
