Change Control and Management
Written production and process control procedures are followed in the execution of the various production and process control functions, and are documented at the time of performance. Any deviation…
Regulatory Agency Reporting
In Europe, the marketing authorization holder is required to take into account technical and scientific progress and to submit amendments that incorporate changes (variations) based on that progress. Additionally,…
Training and Personnel Qualifications
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 11: Training and Personnel Qualifications Good manufacturing practices (GMP) require that personnel have the education, training, and experience needed to perform their…
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…
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…
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…
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…
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…
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…
