Scenario (repeated from previous question): During manufacturing operations of sterile, injectable product batch 2020-A9, intended for release in the United States, you become aware that one of your filling lines has a piece of equipment that is causing micro cracks in the glass vial that holds the liquid drug. These micro cracks are only visible through magnification. You are not sure how long this failure has been occurring.

Based on the above Scenario, do you think this failure only impacts batch 2020-A9? (Select one)

Question

Scenario (repeated from previous question): During manufacturing operations of sterile, injectable product batch 2020-A9, intended for release in the United States, you become aware that one of your filling lines has a piece of equipment that is causing micro cracks in the glass vial that holds the liquid drug. These micro cracks are only visible through magnification. You are not sure how long this failure has been occurring.

Based on the above Scenario, do you think this failure only impacts batch 2020-A9?  (Select one)

Answer

No. You must assume it impacts any batches that occurred while the line functioned in the identified failed condition, and must find evidence of when this condition began.

Answer

Yes. Unless we have proof of when the failure first occurred, we can assume it never happened until it was detected.

Answer

No. You must assume it impacts all batches ever made of this product since the beginning of its lifecycle.

Answer

Yes. You can be confident you would have discovered it sooner if the condition had existed earlier.

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Scenario (repeated from previous question): During manufacturing operations of ...

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