Test Elements for the development of a validation study plan

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QUESTION 1: TO DETERMINE IF ANALYTICAL TESTING IS NECESSARY, ONE SHOULD BE PERFORMED:

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QUESTION 2: THE WORST-CASE SCENARIO CALCULATION CAN BE USED TO ESTIMATE THE LEVEL OF ALLERGEN MIGRATION:

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QUESTION 3: WHICH OF THE FOLLOWING IS A METHOD USED TO CALCULATE MATERIAL LOST DURING PRODUCTION?

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QUESTION 4: WHICH OF THE FOLLOWING IS RELATED TO THE PERFORMANCE OF THE VALIDATION PROCESS?

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QUESTION 5: ALL INDIVIDUAL PRODUCTION LINES MUST BE VALIDATED

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QUESTION 6: FOR SUBSTANCES IN PARTICULATE FORM WHERE CONTAMINATION IS USUALLY HETEROGENEOUS, ANALYTICAL TESTS ARE NOT RECOMMENDED AS THEY MAY GENERATE UNRELIABLE RESULTS

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QUESTION 7: BY MEASURING HOW MANY INGREDIENTS ARE ALLERGENS, THE LEVEL OF ALLERGENS THAT CAN BE CONSUMED IN THE FINAL PRODUCT CAN BE DETERMINED

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QUESTION 8: TO VALIDATE A PRODUCTION LINE, USE THE FORMULA OF THE PRODUCTION LINE WITH THE HIGHEST ALLERGEN LEVELS AND THEN USE THE FORMULA OF THE PRODUCTION LINE WITH THE HIGHEST ALLERGEN LEVELS AND THEN USE THE FORMULA OF THE PRODUCTION LINE WITH THE HIGHEST ALLERGEN LEVELS AND THEN USE THE FORMUL

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INCORRECT QUESTIONS

Is there any error or improvement?

Where is the error?

What is the error?