GxP Periodic Review

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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

11 Questions3 MinutesCreated by AnalyzingData42

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

GxP Periodic Review

GxP Periodic Review Quiz

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