Quality assurance and batch release for the Swiss market

Who may release a medicine for the Swiss market?

Release for the Swiss market is done by the Qualified Person of a company holding the appropriate Swissmedic establishment licence. For imported medicines that means a Swiss licence holder checks the batch documentation against the Swiss authorisation before the product is placed on the market. Their Head of Quality holds that function.

Swissmedic requires a named, technically responsible person for licensed activities, and the establishment licence is issued to the company for defined operations: manufacture, import, wholesale, export. The person is accountable for the operation, so the appointment and resources must match the licensed activities.

What batch release for Switzerland involves

Release is a documented decision, not a signature at the end. For each batch external providers check that the manufacturing and testing documentation matches the Swiss authorisation, that the packaging and product information are the approved Swiss versions, and that transport and storage conditions held from the plant to their warehouse.

1. Documentation review: batch record summary, certificate of analysis, deviations affecting the batch.
2. Comparison against the Swiss authorisation: composition, shelf life, storage conditions, pack configuration.
3. Swiss labelling and product information check, including the three language versions and the dispensing category.
4. Transport and cold chain verification, with temperature data where applicable.
5. Release decision recorded and signed, with the batch traceable to the Swiss market.
6. Retained sample handling and documentation storage for the legal retention period.

The Swiss quality system external providers operate for you

The holder needs a quality system that covers the Swiss market activities, and it has to be a real system with documented events, not a binder. External providers operate their quality system in Switzerland and connect it to yours through a technical agreement.

• Technical and quality agreements with you, your manufacturer and your wholesaler, written for inspection.
• Deviation and CAPA handling for Swiss market events, with root cause work rather than a note in a file.
• Complaint handling from Swiss pharmacies, hospitals and patients, in three languages.
• Quality defect assessment and, where required, notification to Swissmedic.
• Recalls and field actions coordinated with Swissmedic, the wholesaler and the cantonal pharmacists.
• Self-inspection and supplier audits by their own GMP/GDP auditor.
• Change control that links a manufacturing change to its Swiss regulatory consequence.

How a recall actually runs in Switzerland

Speed comes from having the addresses ready before you need them. A Swiss recall means informing Swissmedic, the wholesaler, the cantonal pharmacists and, depending on the level, the pharmacies and hospitals directly, in German, French and Italian, on the same day. External providers hold those distribution lists per product and rehearse the process in self-inspection.

Because external providers also hold the import and wholesale licence, the physical side, quarantining stock and taking product back, happens in the same building as the decision. That is the practical argument for keeping quality and distribution with one partner.