Good manufacturing and distribution practice
In the medicines chain the supplier is part of the authorisation.
Sourcing active substances or distributing medicines means qualifying the chain without gaps – from the API manufacturer through the wholesaler to the transport provider.
Good manufacturing practice requires active substances to be sourced only from qualified manufacturers. That includes on-site audits, written quality agreements and testing of each delivery. The qualified person takes responsibility for release – and therefore for the chain behind it.
Good distribution practice starts at the trading tier: suppliers and customers must be qualified, transport conditions maintained and evidenced, and recalls must be executable at any time. In Switzerland the therapeutic products law and its authorisation duties come on top.
Who is affected
- Manufacturers of medicinal products and active substances.
- Wholesalers, importers and distribution partners.
- Transport and storage providers handling temperature-controlled goods.
- Contract manufacturers and fillers.
- Laboratories performing release testing.
What applies to the chain
- Qualification
- Qualify API manufacturers and suppliers before the first delivery, risk-based and with audits.
- Quality agreement
- Delimit responsibilities in writing, change notification included.
- Traceability
- Batch-level traceability across every stage.
- Transport conditions
- Evidence temperature and integrity along the route.
- Recalls
- A procedure that can retrieve goods at any time and across all stages.
How SCRM covers it
Qualification status
Who is qualified for which substance, since when and until when.
Agreements with expiry
Quality agreements and authorisations with validity and reminders.
Audit programme
Supplier audits with cycle, findings and action tracking.
Recall contacts
Reachability recorded and confirmed on schedule.
Frequently asked
How often must an API supplier be audited?
Set on a risk basis and adhered to. Three-year cycles are common, shorter for critical substances or after findings.
Can audits be performed by third parties?
Shared audits are common and acceptable where scope and qualification are traceable and you assess the result yourself.
What applies additionally in Switzerland?
Authorisations under therapeutic products law and supervision by Swissmedic. The supplier qualification requirements are comparable in substance.
As of July 2026. The applicable guidelines and national law govern. Not legal advice.