PIC/S · Life Science & Pharma: GxP - CSV & Data Integrity
PIC/S Guide to Good Manufacturing Practice (PE 009)
In force Quality foundations · Guideline Last verified: not yet · Source last checked 3 Nov 2026
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- Quality foundations
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- Guideline
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- GMP guide & annexes
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The GMP guide used by inspectors in many countries. It closely follows the EU GMP Guide, so it sets a shared baseline for manufacturers.
How to read this page
- The line under the title explains in plain words what this item is for. The coloured label beside its status gives its Category, its main subject, and Sub Category, the type of document, in the same colours as the maps.
- Status comes from the latest dated event below, and each event links to its source.
- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
- In plain English is our own summary, not the official text. Where we have read the document in detail, a fuller profile follows, with its context, scope, contents and key points.
- Related shows links to other documents. Select Compare to see two side by side.
Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17
In plain English
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.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
PE 009 is the PIC/S Guide to Good Manufacturing Practice, used by PIC/S member inspectorates worldwide. It closely follows the EU GMP Guide. This version, PE 009-18, is dated 23 September 2026, and it reflects the revised Annex 19 on reference and retention samples. It carries a computerised systems annex equivalent to EU Annex 11.
Who and what it applies to
Member inspectorates of PIC/S and the manufacturers they inspect. National rules decide how it applies in each country. This site treats PIC/S as link-only.
What it contains
- Introduction
- Scope and use of the guide.
- Part I
- Basic requirements for medicinal products.
- Part II
- Basic requirements for active substances.
- Annexes
- Supplementary requirements, including computerised systems.
Key points
- It is the GMP reference for many countries outside the EU.
- Its computerised systems annex matches EU Annex 11.
- New versions follow EU changes, so check the version number.
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.
- If you supply several markets, track PE 009 as well as EudraLex.
- Health Canada and Japan both draw on it: see their records on this site.
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 |
|---|---|---|---|
| 30 Oct 2026 | Checked: PE 009-18 listed as current on PIC/S publications page | In force | Source for Checked: PE 009-18 listed as current on PIC/S publications page |
| 23 Sep 2026 | PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17 | In force | Source for PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17 |
Related
How other documents connect to this one. Links explained
- Counterpart of Annex 11 (2011)· Compare with Annex 11 (2011) Unverified link
- Implemented by Health Canada GUI-0050· Compare with Health Canada GUI-0050 Unverified link
- Implemented by Japan PIC/S GMP notice· Compare with Japan PIC/S GMP notice Unverified link
- Interpreted by PIC/S PI 011-3· Compare with PIC/S PI 011-3 Unverified link
- Interpreted by PIC/S PI 006-4· Compare with PIC/S PI 006-4 Unverified link
Official source
The official text always prevails over anything on this site.
Summary in our own words. See the official text from PIC/S.
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