A commercial contract sets prices and business terms. A quality agreement should make the operational responsibilities understandable to both teams. Use a responsibility matrix: activity, responsible party, supporting party, evidence and escalation contact. Do not leave the practical handover to a generic promise of compliance.
Questions to resolve with your Swiss partner
Work through a normal batch and a failed batch with the proposed partner. Who receives the documents, checks completeness, handles temperature excursions, approves a deviation and contacts the product owner? Ask how complaints, safety information and potential recalls are transferred. Agree document access and change notification before the relationship depends on a single person’s inbox.
- List the documents and decisions needed before first supply.
- Assign deviation, complaint, return and recall responsibilities.
- Document contact details, deputies and escalation arrangements.
- Agree change control, subcontractor oversight and access to records.
This independent resource helps pharmaceutical businesses prepare questions for appropriately qualified providers. It is not a regulator, licence holder or substitute for product-specific regulatory advice. Official publications and the applicable legislation take precedence. No authorisation outcome, provider availability, fee or completion date is guaranteed.
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