Document title Contents
API GMP and Administrative information (if unaudited facility) GMP Related: Recalls, OOS/OOT, CAPA, deviations, facility inspection failures (if any), recent regulatory inspections and warning letters/import alerts.
Administrative: New API holder DMF letter of access, API facility inspection declaration letter (EU), QP declaration letter (EU), APIs establishment inspection report and Supply capacity and Material price statement. Patents certification (if required)
Module-1 USFDA: Form-356h; cover letter, API DMF document letter of authorization; request for Biowaiver (if applicable).
EMA: cover letter, application form [annexures for new API supplier information including facility and corporate office address, Brief description of API manufacturing process, Description of GMP facility, GMP certificates and qualified person for batch release declaration letters] and product related information.
Table 3: Documentation requirements for adimistrative part.