General Inspection Readiness

21 CFR Part 211, the US cGMP regulations, state that all records required by cGMP must be readily available for authorized inspections throughout their retention period. Data integrity standards require firms to ensure all data are available, enduring, and complete throughout their retention period.

The Food, Drug & Cosmetic Act grants FDA the authority to inspect any facilities involved in producing, testing, or distributing any products they regulate.

Inspections are a vital mechanism health authorities use to protect public health, by ensuring that firms are operating in a high state of control, producing safe and effective medicines, and maintaining robust quality systems.