The NDA/ANDA Pre-Approval Inspection Compliance Program, dated 10/1/90, requires that manufacturing processes be validated  prior to approval of the NDA/ANDA.  Later the agency relaxed this requirement for non-sterile products.  In the case of non-sterile products, the applicant is allowed to validate the manufacturing process and laboratory control procedures following approval of the application, but they must satisfactorily complete validation prior to shipment.

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