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In order to mainain pharmaceuticals safety, engineering, fabrication, installation and must be based on GMP (Good Manufacturing Practice).
We support customers' validation procedures with our rich GMP experience in engineering, fabrication, construction and quality control for pharmaceutical plants.
Application of GMP to pharmaceutical manufacturing equipment
This is an example of delivery of GMP compliant pharmaceutical plant.
GMP (Good Manufacturing Practice) is a set of strict principles relating to pharmaceuticals production.
Validation is “verification that the structural equipment, procedures and processes of a manufacturing plant as well as other manufacturing controls and quality control methods can obtain the expected results, and by documenting these procedures, verification that pharmaceuticals with the target quality can be continuously manufactured.” This leads to the obligation to document and maintain all of the practices, from design to execution. Therefore, for engineering, installation, inspection, and commissioning of pharmaceutical plant, it is necessary to plan and implement DQ (Design Qualification) for the design stage, IQ (Installation Qualification) for the installation and inspection stage, OQ (Operating Qualification) for the commissioning stage, PQ (Performance Qualification) for the actual fluid commissioning stage, and PV (Process Validation) during sample production for approving products and equipment.
We determine the Validation Master Plan (VMP). (We clarify the organization, content, documents, objectives and proposal period.)
Before starting design, we check whether or not the User Required Specification (URS) from the customer is clear at design commencement, and we set conditions for any insufficiencies.
Equipment and electrical, instrument, monitoring and computer system, piping, HVAC, civil and architecture
This equipment is suited to customers in the pharmaceuticals production business.
Contact us from here.