Preapproval inspections packaging

The formal validation is often completed after the PAI, where three-batch process validation will be conducted in accordance with the protocol approved during the preapproval inspection. The primary objective of the formal process validation exercise is to establish process reproducibility and consistency. Such validation must be completed before entering the market. The formal validation studies continue through packaging and labeling operations (in whole or in part), so that machinability and stability of the finished product can be established and documented in the primary container-closure system. 

FDA-483 Citation 1] Firm was not prepared to host Preapproval Inspection, although it had been scheduled with the FDA and the QA Director had indicated the timing was appropriate. Several critical pieces of manufacturing equipment, while in the area, were not fully installed or qualified. Additionally, there were several incomplete validation protocols for the manufacturing and packaging operations. 

Preapproval inspection (PAI) An inspection by the FDA of the facilities that are proposed as the manufacturing, packaging, and testing sites in the NDA. The PAI normally occurs during the review process. Besides inspecting the facilities, the documentation will be reviewed for compliance to GMPs, SOPs and to verify the integrity of the data in the submission. 

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