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Questions and Answers
Who must review important GMP records such as batch records and analysis records?
Who must review important GMP records such as batch records and analysis records?
- QM department
- Reviewers conduct the reviews themselves (correct)
- Assigned personnel
- Department manager
When should batch records and analysis records be reviewed?
When should batch records and analysis records be reviewed?
- Every six months
- At the time of creation (correct)
- Once every two months
- Only if requested by the QM department
If reviewing of a record is not regulated in related procedures, who will conduct the review?
If reviewing of a record is not regulated in related procedures, who will conduct the review?
- External auditing team
- VP of Operations
- QM manager
- Department manager or assigned personnel (correct)
What action should be taken by the reviewer if a record is found to be invalid?
What action should be taken by the reviewer if a record is found to be invalid?
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When should a reviewer write 'REVIEWED', sign, and date into a record?
When should a reviewer write 'REVIEWED', sign, and date into a record?
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In what cases should continuous logbooks be reviewed?
In what cases should continuous logbooks be reviewed?
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What is the consequence of not reviewing records like machine usage logs or room clearance checking records?
What is the consequence of not reviewing records like machine usage logs or room clearance checking records?
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Who is responsible for preparing a deviation report in case a record is found invalid?
Who is responsible for preparing a deviation report in case a record is found invalid?
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What should be done if a record is found invalid?
What should be done if a record is found invalid?
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Which department should receive the deviation report if needed?
Which department should receive the deviation report if needed?
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