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Pre-approval FDA conducts pre-approval inspections before a New Drug. The purpose of a pre-approval inspection PAI is to ensure that your facility is in compliance with FDA rules and regulations.

Compliance Program Guidance Manual CPGM 734632 lists the criteria for priority pre-approval inspections Figure 1 Figure 1 FDA.

FDA does not have express legal authority to take photographs during an inspection But the agency's current position is that photographs are a reasonable part of the inspection process Therefore investigators may insist they have a right to use a camera.

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FDA Guidance Documents FDA Guidance Manuals for Inspectors Review. Finally we'll end with a look at what is said in the FDA's Compliance Programme Guide 734632 on Pre-Approval Inspections 11 and the.

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A pre-approval inspection is performed by FDA to ensure that a manufacturing establishment named in a drug application is capable of manufacturing a drug and that submitted data are accurate and complete.

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According to ISO an inspection is An examination of a product process service or installation or their design and determination of its conformity with specific requirements or on the basis of professional judgment with general requirements ISOIEC 17000 definition.

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What is a Pre-Approval Inspection The FDA conducts PAIs to assure that a manufacturing site named in a drug application can manufacture the.

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