Global Regulatory Framework
United States Public Health Service Act The United States Public Health Service (PHS) originated in name in 1798; however, the PHS Act of 1944 consolidated many previous…
PHARMACY
Risk Management
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…
Quality Unit (Site) Management
!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…
Regulations and Guidances
!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…
Regulatory Inspections
!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…
Enforcement Actions
!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…
Mutual Recognition Agreements
!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…
