Glossary
Cross-Contamination
Contamination of one material or product by another material or product.
Source · ICH Q7, §20 Glossary, Cross-Contamination; PIC/S PE 009-17 Glossary
Details
Cross-contamination is the contamination of one material or product by components, dust, or microorganisms originating from another. Inspections check whether air handling and pressure differentials in shared facilities, dust migration, campaign production, personnel and material flows, cleaning verification, and the criteria for dedication are proportionate to the toxicological, sensitisation, and exposure risk. Look at facility and HVAC drawings, the cross-contamination risk assessment, cleaning validation, residue limits, the production sequence, and environmental and product test data.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You have not demonstrated that your cleaning procedures are adequate to prevent cross-contamination between the OTC drug products and nondrug products manufactured at your facility.
FDA · FDA Warning Letter · 2022-08-16 -
Your firm failed to adequately validate your equipment cleaning process to demonstrate its effectiveness to prevent potential cross-contamination between your OTC drug products and non-pharmaceutical products.
FDA · FDA Warning Letter · 2026-01-20 -
Your firm handled hazardous drugs without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.
FDA · FDA Warning Letter · 2021-11-16
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, Cross-Contamination; PIC/S PE 009-17 GlossaryGRM Regulatory Glossary
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