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Course 3636
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In class, we discussed the fact that "The Label is the Driver". We were referring to the fact that the information you want to have on the label is important to know during the early stages of your product development so you can prove what you want to claim, and disprove (hopefully) what you do not want to have to put on the label.
- Give 3 examples of types of information typically found on a label, and the studies you would conduct to prove each piece of information.
- Give 1 example of a type of information you do not want to have to put on your label, and the study you would conduct to collect that information.
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)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)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, if you determine that product on the market has been impacted by this failure, what step is the company required to take next? (Select one)B- If your patients are not able to detect the presence of cracks in the vial, does this typically increase or decrease the risk score? Why?
Scenario: 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. A - If your sterile product is being held in vials that have micro cracks present, how would you score the impact this situation could have on your patients? You may give this situation a score of low or high. Explain why you chose the score you did. What is the danger to patient safety of having a cracked vial for an injectable product?
- (3 points) Rank the 3 manufacturing change examples from lowest risk (Level 1) to highest risk (Level 3) based on the risk the change could pose to the product quality.
- (3 points) All three situations must be included in the site's Annual Product Review report to the FDA. What additional report, if any, is needed? Select from Pre-market Approval, CBE-30, or no additional report needed.
If after submitting a CBE-30 to the FDA for changes to a product or process, a company has not heard any concerns from the FDA after ___A___ days, then the company is allowed to____B_____