Preapproval inspections equipment

Eventually the point will be reached at which the development of a product is complete the formulation is finalized, the equipment has been selected, the analytical methods are validated, the development transfer report has been issued, and the Preapproval Inspection (PAI) is anticipated. Now is the time to consider validation of both the manufacturing and cleaning processes. Although some process validation may have also been completed or a process validation protocol may have been prepared and approved, it is likely that very little has been finished that would enable us to state that the cleaning process is fully validated. 

Preapproval inspections can be very comprehensive in nature. Firms therefore need to be well prepared before the arrival of the FDA investigators. The field investigator will in all likelihood audit development data during the course of the inspection for authenticity as well as for accuracy. Additionally, he or she will determine if the facilities, personnel, equipment, and laboratory methods adequately support the manufacturing process in the NDA. The items likely to be reviewed by the FDA investigator(s) during the course of the inspection are shown inTable 2. 

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. 

In a well-designed validation program, most of the effort should be spent on facilities, equipment, components, methods, and process qualification. In such a program, the formalized, final three-batch validation sequence provides only the necessary process validation documentation required by the FDA to show product reproducibility and a manufacturing process in a state of control. Such a strategy is consistent with the FDA preapproval inspection program directive. ... 

Assembly should be eonducted using preapproved procedures. The quality of assembly work, including software installation, should be monitored. Many organizations deploy visual inspection and diagnostic testing to eonfirm that the computer system s hardware has been correctly assembled. Some companies tag assembled equipment that has passed such a quality check so that it can be easily identified. 

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