Chemgineering uses the V-model for systematic qualification. The GMP critical points of user requirements, system specifications and technical specifications are reflected in the individual tests.
Qualification plan: System-specific qualification activities, responsibilities, scheduling and documents to be created are defined.System specifications (FS, HDS, SDS, R & I / EMSR scheme): Description of the technical equipment as a basis for development, construction and installation.
SAT test: Technical acceptance in the supplier's factory / technical acceptance after delivery and installation by the operator / user.
Design qualification (DQ): Documented proof that quality-relevant requirements were taken into account during planning. The compliance with URS and system specifications is checked.
Installation qualification (IQ): Documented proof that equipment and systems have been delivered and installed in accordance with GMP-critical requirements and statutory safety regulations. Measuring and control technology, built-in materials, surfaces and quality-relevant measuring points are tested.
Operational qualification (OQ): Documented proof that the system functionality defined in accordance with the system specifications is completely fulfilled within the entire working area and within specified limits. Qualification report: Approval of the OQ report can be started with a subsequent PQ or process validation.
Performance qualification (PQ): Documented proof that all the relevant plant components and systems meet the defined specifications and requirements in an operating condition.