The PIC/S package · PIC/S international
The PIC/S GMP Guide for computerised systems, on the international core.
For sites inspected by a PIC/S participating authority outside the EU, the UK, the US and Switzerland. The package adds the PIC/S GMP Guide PE 009 on computerised systems, documentation, outsourced activities and qualification to the core. Where the inspecting authority adds its own guidance to it, the package carries that too, for the authorities you choose.
- Regulators
- PIC/S participating authorities
- Languages
- English
- Paper
- A4
The PIC/S GMP Guide
Annex 11, Chapter 4, and the IT-related parts of Chapter 7 and Annex 15 of PE 009, as a rule pack labelled guidance: its binding force depends on how your authority adopted it.
Your inspecting authority
Choose who inspects your site; national guidance limited to that authority, such as Health Canada's, comes into use only then.
Authorised Person
The department profile and the annex SOP use the PIC/S term for the person who certifies batches.
Contents
What the PIC/S package contains
The core and the package's own rule packs, by status. Each rule is paraphrased with its section number, cites its source and names its status; documents name the packs they are written against.
PIC/S package
- Guidance
Health Canada GMP guide (GUI-0001) and Annex 11 (GUI-0050): records, data governance, computerized systems
Version 2026-10-09 v2 · 12 rules · only where Health Canada inspects
- Guidance
PIC/S GMP Guide PE 009-18: computerised systems, documentation, outsourcing, qualification
Version 2026-09-24 v3.1 · 78 rules
International core
- Guidance
ICH Q10 (2008): pharmaceutical quality system
Version 2008-06-04 v3.1 · 7 rules
- Guidance
ICH Q9(R1) (2023): quality risk management
Version 2023-01-18 v3.1 · 10 rules
- Guidance
PIC/S PI 011-3: good practices for computerised systems (2007)
Version 2007-09-25 v3.1 · 24 rules
- Guidance
PIC/S PI 041-1: data management and integrity (2021)
Version 2021-07-01 v3.1 · 30 rules
- Guidance
WHO guideline on data integrity (TRS 1033, Annex 4, 2021)
Version 2021 v3 · 26 rules
SOP set
26 global procedures and 1 annex procedure for the package, adopted as drafts in setup, each citing the rules it covers.
The PIC/S package
One licence covers one installation and the package you buy, with every overlay that package offers. Try it first: every installation runs 14 days without a licence.
Every licence includes
- The program for Windows and Linux with checksums; a Docker image for a server on request
- The international core and the package you buy, with all its overlays
- English and the package's local languages, for the interface and the documents
- Your licence key straight away in the licence portal, for the installation ID you enter
- After the included update period: support and updates as a yearly subscription you can end at any time
Questions about the PIC/S package
Why is PE 009 labelled guidance?
PIC/S doesn't make law: each participating authority adopts the GMP Guide in its own way. The package ships it as guidance and says so; your national requirements decide what binds.
Which authorities does the package know?
It can be used under any PIC/S participating authority outside the EU, the UK, the US and Switzerland. Where an authority adds guidance of its own that the package carries, you choose it in setup or later under Settings → Package; today Health Canada (with its GMP guides as a rule pack), the Therapeutic Goods Administration (Australia) and the Health Sciences Authority (Singapore), whose publications are on the regulatory watchlist.
Is it different from the EU texts?
Annex 11, Chapter 4 and Annex 15 of PE 009 match the EU texts except for the term Authorised Person and one sentence in Chapter 4. The PIC/S package keeps its own pack, written from the PIC/S text, so its sources are PIC/S sources.
Topics
- CSV documentationWhich documents a GxP system's validation needs, how they depend on each other, and how to keep them consistent without writing each one from scratch.
- GAMP 5 categoriesHow a system's software category and criticality decide how much specification and testing it needs, and why that is a judgement, not a formula.
- Data integrityWhat the international guidance expects for the integrity of GxP data, and which part of it the IT department implements and has to show.
- PIC/S GMP Guide (PE 009)What the PIC/S GMP Guide asks of computerised systems, documentation, outsourced IT services and qualification, for sites inspected by a PIC/S participating authority.
Find out in one session whether it fits your department.
The webinar walks through setup, a system from intended use to release, the documents and the IT controls that keep it validated.