10 Questions
Who must review important GMP records such as batch records and analysis records?
Reviewers conduct the reviews themselves
When should batch records and analysis records be reviewed?
At the time of creation
If reviewing of a record is not regulated in related procedures, who will conduct the review?
Department manager or assigned personnel
What action should be taken by the reviewer if a record is found to be invalid?
Prepare a deviation report or request correction
When should a reviewer write 'REVIEWED', sign, and date into a record?
After the review process is completed
In what cases should continuous logbooks be reviewed?
Before replacing them due to updates or other causes
What is the consequence of not reviewing records like machine usage logs or room clearance checking records?
Potential loss of data integrity or validity issues
Who is responsible for preparing a deviation report in case a record is found invalid?
Reviewer of the record
What should be done if a record is found invalid?
Request for correction or prepare deviation report.
Which department should receive the deviation report if needed?
QM Department
Learn about the challenges related to batch record errors, space constraints, and the process of adding additional pages. Understand when a deviation report may not be necessary according to the Quality Management department.
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