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 Scenario above, what immediate steps would you take internally to reduce the risk of harm to patients? (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 Scenario above, what immediate steps would you take internally to reduce the risk of harm to patients?  (Select one)

Answer

Notify the FDA and make a warning announcement on your personal Facebook page.

Answer

Get maintenance to fix the line immediately and try to resume production same day.

Answer

Stop production, place holds and quarantine unreleased product, start an investigation, and notify management of the potential impact.

Answer

Contact the patient group for the particular illness by email explaining the problem.

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

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