The CH package · Switzerland
The GMP rules Switzerland applies to computerised systems, and the Swiss data protection act, on the international core.
For sites licensed and inspected by Swissmedic. The Medicinal Products Licensing Ordinance (AMBV) anchors the GMP rules that apply in Switzerland, among them Annex 11 on computerised systems, Chapter 4 on documentation, Chapter 7 on outsourced activities and Annex 15 on qualification. The package adds them to the core and offers the Swiss Federal Act on Data Protection as an overlay.
- Regulators
- Swissmedic
- Languages
- English, German
- Paper
- A4
The Swiss anchoring
The AMBV's licensing conditions, the Responsible Person and the inspectors' powers as a rule pack, next to the GMP texts it makes binding.
Swiss data protection as an overlay
The FADP and its ordinance: records of processing, processors, data security, impact assessments, breaches notified to the FDPIC, requests within 30 days.
In English and German
Interface and documents in English or German; French and Italian follow once their translations have been reviewed.
Contents
What the CH 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.
CH package
- In force
Annex 11 (2011) + Chapter 4 (2011)
Version 2011-06-30 v3.1 · 47 rules
- In force
Swiss Medicinal Products Licensing Ordinance (AMBV/MPLO): GMP anchoring
Version 2025-03-15 v1 · 5 rules
- In force
EU GMP Annex 15 (2015): qualification of IT infrastructure and systems
Version 2015-10-01 v3.1 · 18 rules
- In force
EU GMP Chapter 7 (2013): outsourced activities, applied to IT services
Version 2013-01-31 v3.1 · 13 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
Overlays, included
Switched on in setup where they apply to you; recommended ones are preselected.
Data protection
recommendedPersonal data in GxP systems: records of processing, processors, technical and organisational measures, impact assessments, breaches and data subject requests.
- In force
Swiss Data Protection Act (FADP) and Ordinance (DPO): IT obligations
Version 2025-12-01 v1 · 35 rules
SOP set
26 global procedures and 1 annex procedure for the package, adopted as drafts in setup, each citing the rules it covers. Overlays add their own procedures.
The CH 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 CH package
Why does the Swiss package contain the EU GMP texts?
Because the AMBV makes them the Swiss GMP rules: its Annex 1 names the EU GMP Guide and the PIC/S principles. The package uses the same Annex 11, Chapter 7 and Annex 15 rule packs as the EU package and adds the Swiss anchoring; the EU's 2025 drafts are not part of it.
Who is the Responsible Person in the documents?
The fachtechnisch verantwortliche Person of the AMBV, who releases batches. The department profile and the Swiss annex SOP use the Swiss term.
Which data protection rules does the overlay follow?
The Federal Act on Data Protection and its Ordinance in their current versions, with the obligations IT implements, documents or contracts for as they apply to private companies. The German text is binding; the rules paraphrase the official English translation and cite the article numbers.
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.
- Swiss data protection (FADP)Which obligations of the revised Swiss data protection law fall to the IT department of a company licensed by Swissmedic, and how to keep them next to the validation records of the same systems.
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.