Company XXX has purchased three Fette compressing machines. All are exactly alike. What type of qualification studies do you need to perform?
Which of the following requirements must exist to classify a component as critical?
	The component has direct contact with the product.
	The component supplies a material or solvent that has direct contact with the product.
	The component is used in cleaning or sterilization of a product or equipment.
	The component produces data used in the release or rejection of a product.
	The component controls or monitors the process in a way that can affect product quality.
Which of the following is NOT a Supplier Audit criterion?
	Process Control
	Product Identifcation and Traceability
	Internal Audits
	Rating Analysis Recap
Which of the following is not a General Requirement in a cleaning validation program?
	Written procedures on how cleaning processes will be validated.
	Written validation protocols in advance.
	FDA approval of new drug application (NDA)
	Validation report stating whether or not cleaning process is valid.
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