Service 03 / 05
GMP & GDP Quality.
Quality processes and distribution-side integrity within an agreed product scope.
AFZ operates a GMP-certified quality system for manufacturing and GDP-compliant distribution under authorisation by the Office of Public Health, Principality of Liechtenstein. We coordinate specification control, supplier and CMO qualification, batch documentation, traceability, controlled storage and recall readiness around the agreed product and partner scope.
Our approach
Documented, or it did not happen.
A quality system is only worth the records it produces. Ours is built so that any batch, supplier decision or deviation can be reconstructed years later — which is what an inspection actually tests.
Partners receive the same discipline we apply to our own brands: written specifications before production, qualified suppliers only, and a recall procedure that has been rehearsed rather than merely written.
What you get.
Concrete deliverables — not a strategy deck that dies in a drawer.
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Specification control
Raw material, bulk and finished-product specifications, approved and version-controlled.
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Supplier & CMO qualification
Written assessment, documented approval and periodic re-evaluation of every partner.
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Batch documentation
Complete batch records with review and release by the responsible person.
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Traceability
Forward and backward traceability from incoming material to receiving customer.
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Controlled distribution
Defined storage conditions, monitored transport and documented handling under GDP.
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Deviations & recall
Deviation handling, CAPA and a tested recall procedure with defined roles.
Built for.
Three situations where this service pays for itself.
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Brand owners coordinating quality partners
You need documented responsibilities without building every capability inside one organisation.
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Partners facing an audit
You need documentation, agreements and questionnaires that survive customer or authority scrutiny.
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Complex supply chains
Multiple CMOs and suppliers, with no single point of accountability for quality decisions.
Common questions.
Straight answers — the rest we cover on a call.
Can we audit your site?
Yes. On-site and remote audits are welcome and routinely scheduled. Propose a window and we will confirm availability with the responsible person.
Do you provide a quality agreement?
We have a standard quality agreement available for review before any technical discussion, and we adapt it to the scope of the specific engagement.
Which documents can partners review?
Document availability depends on the product, market and agreed due-diligence scope. Tell us what your review requires and we will confirm the current document set.
Need our certificates or quality agreement?
Tell us the product, market and document required for your review.
Services are scoped to the product, territory and responsibilities agreed with AFZ and qualified partners. National authorisations, MAH roles and reimbursement pathways apply only where legally applicable and explicitly mandated.