Supplier qualification programme formalised
Ergopharm has formalised how it approves the companies that supply its materials, replacing case-by-case sourcing with an approved supplier list, documented assessment and periodic re-evaluation.
Approval now requires a technical questionnaire, review of the supplier's own quality system, an on-site audit for critical materials, and qualification of three consecutive lots against the site's own specification before routine supply begins. A supplier who cannot support this is not used for critical materials, whatever the commercial case.
“You inherit your supplier's quality system whether you have read it or not.”
Every incoming container of a starting material is identity-tested on arrival. Reduced testing of other attributes is permitted only where the supplier is qualified and a history of conforming results exists, and the identity test is never reduced.
Printed packaging components are handled under the same discipline, with artwork version control and reconciliation of printed materials at the line — the control that prevents the wrong label reaching the right product.
Key facts
- Approval
- Questionnaire · quality-system review · audit for critical materials
- Qualification
- Three consecutive conforming lots
- Incoming control
- Identity tested on every container
- Packaging
- Artwork version control and line reconciliation