GVP Deviations Categorization
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Dear colleagues, I'd like to know your opinion about GVP deviations - considering the grading stated in GVP IV.B.2.3.2. Reporting, would you consider a 5-day delay in 1 PSUR submission minor or major? What about delays in ICSR submission?
Open CAPA associated with critical/ major deviations need to be included in the main body of PSMF; hence companies tend to be conservative in categorizing observations.
For your question, there is no direct answer, as this depends on the following factors:
1. Extent of delay of ICSR, the type (Seriousness/ expectedness) and the significance of the event. E.g., a non serious expected ICSR Vs a Serious Unexpected ICSR or 5 days delay Vs 75 days delay
2. Reason for delay in PSUR submission - Technical/ portal Issues? QPPV availability? Delay in review or sign off?
3. Repetitive observation? Ineffective CAPA?
4. Other factors