RESPONSE TO WHO GMP OBSERVATION
Observation No.
Environmental Monitoring Not Performed as Scheduled
1. CONTEXT OF OBSERVATION
During the WHO GMP inspection at AABBCC Pharmaceutical Plant, the inspection team observed that Environmental Monitoring (EM) activities were not performed according to the approved monitoring schedule for classified manufacturing areas. The observation indicated deficiencies in the execution and monitoring of the Environmental Monitoring Program despite the availability of an approved SOP and environmental monitoring schedule.
Environmental Monitoring is a critical component of the Pharmaceutical Quality System (PQS) and provides documented evidence that manufacturing environments consistently remain within predefined microbiological and particulate limits. The monitoring program includes viable and non-viable airborne particles, settle plates, surface monitoring, personnel monitoring, differential pressure, temperature, humidity, and HEPA filter performance verification.
The investigation confirmed that although:
- An approved SOP for Environmental Monitoring was available.
- Environmental Monitoring locations were identified.
- Monitoring frequencies were defined.
- Acceptance limits were established.
The monitoring activities were not consistently executed according to the approved schedule, resulting in incomplete records and delayed monitoring of certain classified manufacturing areas.
The deficiency represented a weakness in implementation, supervision, and management oversight rather than a deficiency in the documented procedure.
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Click the link to download the word file copy of this document:
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Click the link to download the word file copy of this document:
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Click the link to download the word file copy of this document:
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR ENVIRONMENTAL MONITORING NOT PERFORMED AS SCHEDULED
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Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-for-environmental-monitoring-not-performed-as-scheduled/
