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Which of the following requirements must exist to classify a component as critical?
|
|
| The component has direct contact with the product.: 161
(23%)
|
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| The component supplies a material or solvent that has direct contact with the product.: 121
(18%)
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| The component is used in cleaning or sterilization of a product or equipment.: 113
(16%)
|
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| The component produces data used in the release or rejection of a product.: 131
(19%)
|
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| The component controls or monitors the process in a way that can affect product quality.: 163
(24%)
|
Which of the following is NOT a Supplier Audit criterion?
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|
| Process Control: 22
(9%)
|
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| Product Identifcation and Traceability: 11
(5%)
|
|
| Internal Audits: 53
(23%)
|
|
| Rating Analysis Recap: 149
(63%)
|
Which of the following is not a General Requirement in a cleaning validation program?
|
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| Written procedures on how cleaning processes will be validated.: 13
(6%)
|
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| Written validation protocols in advance.: 19
(8%)
|
|
| FDA approval of new drug application (NDA): 189
(80%)
|
|
| Validation report stating whether or not cleaning process is valid.: 15
(6%)
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