Japan PIC/S GMP notice and its 1 linked instrument

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	Japan PIC/S GMP notice	PIC/S GMP Guide PE 009
Authority	PMDA	PIC/S
Legal weight	Guidance & Q&A	GMP guide & annexes
Status	Final	In force
Last verified	Not yet	Not yet
Summary	Japanese administrative notice from the health ministry (MHLW), hosted by PMDA, introducing the PIC/S GMP Guide as guidance for GMP at manufacturing sites. The English is a tentative translation. Link only.	The PIC/S GMP guide used by participating inspectorates, including an annex on computerised systems equivalent to EU Annex 11. PIC/S co-drafts the current EU revisions.
Lifecycle	1 Feb 2012 Administrative notice issued	23 Sep 2026 PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17
Source	Official text Summary in our own words. See the official text from PMDA.	Official text Summary in our own words. See the official text from PIC/S.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.