Facility Information

The purpose of this document is to provide clear guidance to the biological drug industry regarding the inclusion of product-specific facility information in drug submissions containing a Quality component (chemistry and manufacturing). This guidance document should be considered in the preparation of all submissions containing a chemistry and manufacturing component which requires facility information, i.e., New Drug Submissions (NDSs), Supplemental New Drug Submissions (S/NDSs) and Biological DIN Applications (DINBs).

In addition, a corresponding guidance document for industry is available regarding the type of submission to file when product-related changes are being made to a facility where an approved drug product is being fabricated.

Please note that Guidance For Industry - Changes in Product-Specific Facility Information replaces the document entitled Bureau of Biologics and Radiopharmaceuticals, Guidance to Industry Product-Specific Facility Information.