GMP services _ DQ, IQ, OQ, PQ _ CSV IQ, CSV OQ _ Process validation _ GMP Consulting Factory and Site Acceptance Test (FAT/SAT) Documented acceptance tests at the supplier/customer’s location with test log, test summary, list of outstanding issues and release certificates. Test Specification (TS) Description of purpose, implemen- tation and acceptance criteria of the various qualification tests. Installation Qualification (IQ) Identification of the plant, checking of the mechanical design, installed components, the GMP documentation, drawing tests, the electrical system, wiring (5% diagram test), the GEP documentation and visualization masks. Operational Qualification (OQ) Review of the safety equipment, functional testing of individual components, checking of the warning and error messages, screen navigation, key functions and password level as well as the input parameters. Quality and Project Plan (QPP) This determines how the quality requirements of the project are met. Activities to be performed, scheduling, responsibili- ties, applicable control mechanisms and operational elements are regulated. Design Specification (DS) The establishment of a technical basis and the specification of the current conditions that should be taken into account in terms of design, construction and installation. This ensures that all customer require- ments and the current standards of cGMP, EU, ISO and FDA are met. Risk Analysis (FMEA) A systematic approach that detects potential problems and estimates their risks with the help of so-called risk priority numbers, in order for countermeasures to be taken. The FMEA allows the machine supplier to assess the risk of its construc- tion and to increase the safety of the production process of the customer.
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DQ, IQ, OQ, PQ Process validation GMP Consulting(DQ, IQ, QQ) with protocol preparation, test procedures and result documentations. Full power ahead for GMP qualification DQ, IQ, OQ,
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