RESPONSE TO WHO GMP OBSERVATION
Observation
Observation: Inadequate Line Clearance Before Batch Start in Granulation Area
Company Name: AABBCC
Manufacturing Site: AABBCC
Inspection: WHO GMP Inspection
CAPA Reference No.: __________
Date of Observation: __________
1. Context of Observation
During the WHO GMP inspection, it was observed that the line clearance process before initiation of batch manufacturing in the granulation area was not adequately performed and documented. Specifically, deficiencies were noted in verification of previous product removal, status labelling, equipment cleanliness confirmation, and completion of line clearance records prior to batch commencement.
The inspection team noted that:
- The documented line clearance checklist was not comprehensively completed.
- Independent verification by Quality Assurance (QA), where required by procedure, was not consistently documented.
- Visual confirmation of removal of materials, labels, and documents from previous operations was incomplete.
- Line clearance documentation lacked sufficient detail to demonstrate systematic verification.
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
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Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
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Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
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Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
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Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Key Parameter of the Below Page:
INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
Find below pages for complete report
Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/inadequate-line-clearance-before-batch-start-in-granulation-area/
