GxP Periodic Review
GxP Periodic Review Quiz
Test your knowledge on GxP Periodic Review processes with this comprehensive quiz! Whether you're new to the subject or looking to validate your expertise, this quiz contains key insights to enhance your understanding.
Each question will challenge you on various aspects of periodic reviews, including documentation, review frequency, and essential compliance systems. Get ready to dive in!
- 11 thought-provoking questions
- Multiple choice format
- Instant feedback on your answers
Periodic review is applicable for GxP applications only
True
False
What is the current effective version to document Periodic review outcome
V5.0
V6.0
V3.0
V5.1
What is the high-level PR activity flow?
Evidence collection-self assessment in tool- identifying gaps-PR draft-PR report approval
Identifying gaps- Evidence collection-self assessment in tool -PR draft-PR report approval
PR report approval-Identifying gaps- Evidence collection-self assessment in tool -PR draft
Self assessment in tool -PR report approval-Identifying gaps- Evidence collection-PR draft
What is the review frequency for GxP medium application?
5 years
4 years
3 years
1 year
As per procedure it is required to update application inventory in SNOW APM once periodic review activity is over.
False
True
When periodic review activity will be marked overdue for an application
At Next PR date
Next PR date+60 days
Next PR date+30 days
None
Which CAPA management system is used to log the identified deficiencies from periodic review activity
AQWA-A
AQWA-Q
1QEM
None
GxP High systems with Risk Tier 1 and Operationally Critical Applications (OCA) classification shall be conducted every 1 year
True
False
Validation master plan is the annual plan for the systems due for periodic review during effective year
False
True
The “Review Start Date” is synchronized with the “Go Live Date” of initial validation or “Review End Date” of the last Periodic Review (whichever is later)
False
True
Only upon completion of GxP Periodic Review exercise, the “Review End Date” should be updated as the “Last Periodic Review” date within application inventory.
True
False
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