There has been a change from traditional inspections of profile classes towards risk-based
system inspections. Safety for patients and consumers is the FDA’s primary concern. As
part of traditional inspections, FDA inspectors have checked compliance of a specific
product during manufacturing stages across departments and systems, such as production
areas, storage rooms, and laboratories. Since 2003, the FDA has been promoting the riskbased
system inspections approach and has defined six systems:
1. Quality Systems: Assures overall compliance with cGMP and internal procedures. The
quality assurance unit is part of this system in addition to Change Control, Management
Controls, Corrective Action and Preventive Action (CAPA), and others.
2. Materials Systems: Includes measures and activities to control finished and
in-process products, components, and closures. Validation of computerized inventory
systems is a part of these systems.
3. Production Systems: Includes measures and activities to control the manufacture
of drugs and drug products. Process validation and development of manufacturing
procedures are part of these systems.
4. Laboratory Control Systems: Includes measures and activities related to laboratory
procedures and processes from sampling to testing and archiving of laboratory records.
5. Packaging and Labeling Systems: Includes measures and activities that control the
packaging and labeling of drugs. Validation of packaging and labeling operations is a part
of these systems.
6. Facilities and Equipment: Includes the measures and activities that provide an
appropriate physical environment and resources. Qualification of manufacturing
equipment and cleaning validation is a part of these systems.
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