Glossary
Personnel Monitoring
Checking, by defined methods, the microbial contamination that may be present on the gloves and gowns of operators in aseptic areas.
Source · EudraLex Volume 4, Annex 1 (2022), §§9.22, 9.25–9.27
Details
People are the main source of contamination in aseptic processing, so monitoring results connect directly to batch impact and to the operator's continued qualification. Inspections cite samples not taken after interventions or on exit, weak justification for locations and frequency, and recurring positive trends not linked to retraining or requalification. Look at glove and gown plate results, operation and intervention records, per operator trends, excursion investigations, and qualification status.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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In addition, in response to the microbial contamination recovered in your ISO 5 aseptic processing areas, you have not provided current environmental and personnel monitoring results of classified areas, including ISO 5 aseptic processing areas.
FDA · FDA Warning Letter · 2024-05-14 -
For example, your firm has not established an adequate program for environmental and personnel monitoring in the aseptic processing area where your product is manufactured.
FDA · FDA Warning Letter · 2026-09-22 -
Your firm does not investigate personnel monitoring excursions that exceed your action limit…
FDA · FDA Warning Letter · 2022-02-22
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EudraLex Volume 4, Annex 1 (2022), §§9.22, 9.25–9.27GRM Regulatory Glossary
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