Observation
Observation: Failure to Record Equipment Cleaning
1. Context of Observation
During the WHO GMP inspection of AABBCC Pharmaceutical Plant, the inspection team observed that equipment cleaning activities were not consistently documented in the approved equipment cleaning records after completion of manufacturing operations. Although cleaning was reportedly performed, the associated cleaning logbooks and records were either incomplete, not signed by responsible personnel, or not recorded immediately after completion of cleaning activities.
The inspection team considered this observation a Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) deficiency because cleaning records provide objective evidence that equipment has been cleaned according to validated procedures before subsequent use.
The investigation confirmed that:
- Approved SOPs for equipment cleaning were available.
- Cleaning validation had been completed for applicable equipment.
- Approved equipment cleaning logbooks existed.
- Equipment status labels were available.
- Cleaning frequencies were defined.
- Cleaning responsibilities were assigned.
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-failure-to-record-equipment-cleaning/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-failure-to-record-equipment-cleaning/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-failure-to-record-equipment-cleaning/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-failure-to-record-equipment-cleaning/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-failure-to-record-equipment-cleaning/
