PMDA · Life Science & Pharma: GxP - CSV & Data Integrity
Administrative Notice on Application of PIC/S GMP Guide (Japan)
Final Quality foundations · Guidance Last verified: not yet · Source last checked 3 Nov 2026
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- PMDA
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- Quality foundations
- Sub Category
- Guidance
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- Guidance & Q&A
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A Japanese notice introducing the PIC/S GMP Guide as guidance for GMP at manufacturing sites.
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Lifecycle
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- Administrative notice issued
In plain English
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.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
This Administrative Notice dated 1 February 2012 from Japan's health ministry (MHLW), hosted by PMDA, introduces the PIC/S GMP Guide as guidance for GMP at manufacturing sites. The English is a tentative translation.
Who and what it applies to
Those involved in GMP at drug and quasi-drug manufacturing sites in Japan.
What it contains
- Content
- Explains the introduction of the PIC/S Guide, alongside the GMP Ordinance.
Key points
- It links Japan's GMP to PIC/S.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Use it to explain how PIC/S applies in Japan.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 1 Feb 2012 | Administrative notice issued | Final | Source for Administrative notice issued |
Related
How other documents connect to this one. Links explained
- Implements PIC/S GMP Guide PE 009· Compare with PIC/S GMP Guide PE 009 Unverified link
Official source
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Summary in our own words. See the official text from PMDA.
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