Validation Evidence Expectations for De-Chlorination in Pharmaceutical Water System

 

 

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#1. De-chlorination is validated in pharmaceutical water systems mainly because chlorine:

#2. From a GMP risk perspective, failure of de-chlorination is classified as:

#3. Validation evidence for de-chlorination must demonstrate control primarily over:

#4. Which design parameter provides the strongest scientific basis for chlorine removal validation?

#5. The purpose of lead–lag carbon filters is to:

#6. EBCT calculations alone are insufficient because:

#7. Chlorine challenge testing is most appropriately performed during:

#8. A typical validated acceptance limit for outlet chlorine is:

#9. Performance Qualification (PQ) for de-chlorination mainly demonstrates:

#10. Which monitoring approach is acceptable when justified by risk assessment?

#11. Trending of outlet chlorine data is primarily used to:

#12. Chlorine monitoring data must comply with:

#13. Which document formally justifies carbon replacement frequency?

#14. A single outlet chlorine excursion slightly above limit should be handled as:

#15. Change of carbon grade requires which GMP action?

#16. An inspector questions why de-chlorination is validated when it does not directly contact product. The best response is:

#17. Increased microbial counts downstream of carbon beds most strongly indicate:

#18. Worst-case inlet chlorine challenge is expected to demonstrate:

#19. Validation evidence is considered incomplete when:

#20. Regulators conclude de-chlorination remains validated when control is shown through:

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