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QualificationWe qualifiy according to the regulations and guidelines of the FDA, GMP und DIN/ISO 9001 |
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| Definition GMP Verification that equipment is appropriate and correct for the process(es) being investigated or validated and runs within the stipulated parameters. Qualification is divided in: Design Qualification (DQ): Documented verification that a new facility design meets all GMP and regulatory requirements. Installation Qualification (IQ): Documented verification that the equipment or systems specified in the design documents are installed in accordance with design and manufacturer’s specifications. Operational Qualification (OQ): Documented verification that equipment and systems operate as specified and meet all requirements. It assures the system operates as intended under various conditions and parameters. Performance Qualification (PQ): Documented verification that the installed equipment systems and utilities function within the required range of operation, regardless of loading. |
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