ABSTRACT
The goal of the pre-approval inspection had been to verify that the data supplied by a sponsor in the marketing application were supported by facts. The introduction of the common technical document (CTD) was designed to aid sponsors in presenting the data that supported their marketing applications in an organized fashion. In a systems-based inspection, the inspectors may select the same documents and compare these with the originals, and continue the inspection into how each of the documents was generated. If the drug substance manufacture has taken place within the same facility as the drug product manufacture, the inspector may choose to have the records associated with the batch of drug substance used in the batch of drug product presented as original documents. The combination of the eCTD formats and the systems-based inspection shift the discussions during the inspection from debate to discussion of the data.
