The mission of the United States Food and Drug Administration (FDA) and equivalent
international agencies is to protect consumer health and safety under the Federal Food,
Drug, and Cosmetic Act or equivalent international laws. The agencies have developed two
basic strategies towards this mission:
• Monitoring the quality of products through surveillance activities such as sampling and
analyzing products in distribution.
• Evaluating through factory inspections the conditions under which products are
developed, manufactured, tested, packed, labeled, and held.
Although the process and implementation of regulatory inspections are very similar for most
regulatory agencies, they are best documented by the US FDA. This is one reason why
this primer’s focus is on US FDA inspections. Another reason is that more companies are
affected by FDA inspections than by any other agency.
The FDA is expected to perform routine factory inspections every two years, and can also
initiate “for cause” inspections for any reason, including poor quality of drugs found during
routine monitoring of drugs on the market or as a result of other serious health risks that
were brought to the FDA’s attention.
Prior to product approval, the FDA conducts a pre-approval inspection; after the product
has been approved, the FDA may conduct a post-approval inspection. In addition, when a
firm makes a change to its product manufacturing process, the FDA should be notified. The
FDA may choose to inspect the new process for compliance.
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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