Validierung, Zertifikate und Rückverfolgbarkeit

Achtung! Der Inhalt dieser Seite ist auf Englisch verfügbar

There are some primary requirements to consider before building packaging machinery that abide by pharmaceutical regulations. These requirements concern validation, certificates and traceability of both materials and the packaging equipment production itself.

Universal Pack uniquely codes every single component, keeps full track of it and provides documentation certifying its compliance with Pharmaceutical industry regulations. An essential list includes for instance: certificates of all materials and parts in contact with the product, welding certificates, calibration certificates and parts full traceability. The provision goes beyond the latter certificates for proving the components quality and compliance, as it stretches to further documents concerning the line construction and effectiveness. The list goes on with IQ (Installation qualification), OQ (Operational qualification), PQ (Performance qualification), FDS (Functional design specifics), HDS (Hardware design specifics) and Risk analysis.

---

Kontrollsysteme