Glossary
Contamination
The unwanted introduction of chemical or microbiological impurities, or of foreign matter, into a material during production, sampling, packaging, storage, or transport.
Source · ICH Q7, §20 Glossary, Contamination
Details
Contamination is the unwanted introduction of chemicals, microorganisms, or foreign matter into a material or product during manufacture, sampling, packaging, storage, or transport. Inspections check whether weaknesses in personnel, material, and waste flows, open processing, equipment condition, cleaning and disinfection, storage, and pest control actually translate into contamination risk. Look at facility and process flow diagrams, hygiene and cleaning procedures, environmental and water data, equipment logs, and deviation and contamination investigation records.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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These practices may introduce contamination into the ISO 5 work area.
FDA · FDA Warning Letter · 2023-08-08 -
You identified the (b)(4) process as increasing the risk of microbiological contamination…
FDA · FDA Warning Letter · 2025-01-21 -
You failed to adequately inspect and maintain your AHUs to ensure air filters would be effective at preventing contamination.
FDA · FDA Warning Letter · 2025-03-04
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7, §20 Glossary, ContaminationGRM Regulatory Glossary
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