KGMP audit statistics

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Read this before you file for a GMP audit. See which documents drew supplementary requests over the past three years and what the notices actually asked for, filtered to your situation.

Three to prepare first

Most-requested documents

Each bar is the share of applications with a recorded supplementary request in which that document was raised. Click a document name to open the actual wording of the notices. The grouping into document types is REGNA's own.

By year

This tool is free. Why we started this · Built from Annex 2 of 「의료기기 제조 및 품질관리 기준」 and the GMP supplementary-request records in the MFDS open API, with the source on every result.

This result is for reference and has no legal force. The clause text is reproduced as it stands; the grouping into document types, the mapping to clauses and the merging of notices that are 90% alike are REGNA's own. Audit bodies, auditors, applicants and manufacturers are not shown. Applications that drew no supplementary request are not in this dataset, so every share is a share within applications that did.