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NDA/ANDA PRE-APPROVAL INSPECTIONS

 

Required under CP 7346.832, Pre-Approval Inspections/Investigations

 

- Determine whether firm is in compliance with Good Manufacturing Practices

 

-Obtain confirmation that test batches were made as described in the NDA or ANDA

(Product -specific)


 

 

LABORATORY DATA IS CRITICAL

 

It provides basic information regarding:

 

Suitability of formulation

Quality and purity of raw materials

Manufacturing process

Attributes of the finished product

Product stability

Bioavailability or bioequivalence of the

product

 

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