Product quality
Quality & Compliance.
Quality information is useful only when product scope, processes and responsibilities are explicit.
AFZ operates a GMP-certified quality system for manufacturing and GDP-compliant distribution under authorisation by the Office of Public Health, Principality of Liechtenstein. The system governs specification control, supplier and CMO qualification, batch documentation, traceability and distribution-side integrity.
Inspections are carried out by the Zurich Regional Specialist Unit on behalf of the authority. Current certificates and supporting documents are available on request during partner due diligence; full documents are not published on this website.
- EEA · CH
- scope of the GMP and GDP authorisation
- 2
- product regimes — medicines and food supplements
- 3
- certification standards — GMP, GDP and IFS Food across manufacturing and distribution
- 6
- documented control areas described below
Scope of the system
What the quality system actually covers.
Six control areas described in AFZ portfolio and quality-system records.
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Specifications
Raw material, bulk and finished-product specifications defined, approved and version-controlled before any production run.
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Supplier & CMO qualification
Written assessment, documented approval and periodic re-evaluation of every manufacturing and supply partner.
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Batch documentation
Complete batch records with review and release by the responsible person, retained per regulatory retention periods.
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Traceability
Forward and backward traceability from incoming material through to the receiving customer.
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Storage & handling
Product-specific storage, transport and handling requirements are documented for the agreed partner scope.
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Deviations & recall readiness
Deviation handling, CAPA and a tested recall procedure with defined roles and reachability.
Quality governance in practice.
Five operating controls guide decisions when quality, documentation and commercial timelines intersect.
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Patient and consumer protection
Product quality, approved use and regulatory obligations take precedence over commercial timelines.
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Documented, not informal
If it is not written down and approved, it is not a process.
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Qualified partners only
No unassessed supplier enters the chain, regardless of price or urgency.
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Transparent agreements
Responsibilities fixed in writing before the first shipment.
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Continuous improvement
Self-inspection, CAPA and periodic review as routine, not as a response to findings.
Two regulatory regimes
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Our manufacturing network
Made in Germany, at scale
Our products are contract-manufactured by established European pharmaceutical producers in German GMP-certified facilities — the same plants that run the brands you already know.
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Working with partners
Qualified, not assumed
Supplier and CMO qualification sits inside the quality system described above, alongside specifications, batch documentation and traceability for the agreed product and partner scope.
Partner and manufacturing scope is confirmed for the product and market under review.
For partners
Three direct routes into our quality organisation.
Choose the document route and give the product or partnership context for the request.
- Quality agreement Receive our standard quality agreement for legal and technical review. Request the document
- Audit scheduling Propose a window for an on-site or remote audit of the agreed product or partner scope. Propose a date
- Technical questionnaire Receive our completed supplier questionnaire with current annexes. Request the file
Questions on scope or documentation?
Tell us which product, market and document your review requires.