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Test Analytical validation requirements

QUESTION 1: HOW MANY CONSECUTIVE RUNS WITH ACCEPTABLE CRITERIA MUST THE SAMPLES PASS IN ORDER TO BE USED FOR ANALYTICAL VALIDATION?

QUESTION 2: IT IS NOT ADVISABLE TO USE ANALYTICAL TESTS WHEN THE ALLERGENIC SUBSTANCE IS IN THE FORM:

QUESTION 3: THE SUPERFICIAL SMEAR IS A METHOD:

QUESTION 4: BETWEEN WHAT VALUES SHOULD THE PH BE IN ORDER TO BE ABLE TO PERFORM THE TEST USING THE RINSING METHOD

QUESTION 5: SAMPLING OF THE FINAL PRODUCT SHOULD BE CARRIED OUT FROM THE:

QUESTION 6: FROM HOW MANY SAMPLES AT DIFFERENT TIMES OF THE FINAL PRODUCT WITH ACCEPTABLE PARAMETERS, THE VERIFICATION IS CONSIDERED SUCCESSFUL

QUESTION 7: IN THE RINSING METHOD, WHEN THE PH IS OUT OF RANGE, RINSING SHOULD BE CONTINUED UNTIL THE PH IS WITHIN ACCEPTABLE PARAMETERS

QUESTION 8: IN CASES WHERE IT IS BELIEVED THAT THE EXISTING CONTAMINATION IS HOMOGENEOUS, THE NUMBER OF SAMPLES PER VALIDATION SHOULD BE INCREASED TO INCREASE THE POSSIBILITY OF DETECTING POSSIBLE CONTAMINATION

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