Tablet Dissolution and Disintegration Qualification Services

Erweka • Vankel • Sotax • Distek • Pharmatest • Caleva • Hanson

The U.S. Food and Drug Administration (FDA) defines validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes".  The essential components of the validation process are Design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ), and a validated computer system.

Our procedures are "Brand Neutral" to allow a harmonised validation standard across all laboratories & all departments irrespective of instrument manufacturer.

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