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Industrial plant : Hitachi

Hitachi

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.

Case introduction

Photograph: GMP application with pharmaceutical manufacturing equipment

Application of GMP to pharmaceutical manufacturing equipment

This is an example of delivery of GMP compliant pharmaceutical plant.

GMP and validation

GMP

GMP (Good Manufacturing Practice) is a set of strict principles relating to pharmaceuticals production.

Validation

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.

Scope of supply

Validation

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.

  • Design Qualification (DQ): We check for GMP compliance at the design stage. We execute DQ1 at the basic design stage and DQ2 at the detailed design stage. (Use of simulation enables verifying that pilot data and actual equipment will be equivalent.)
  • Installation Qualification (IQ): We check for GMP compliance at pre-shipping inspection within a vendor factory, at installation, and at final inspection of construction.
  • Operating Qualification (OQ): We check for GMP compliance of system operating conditions during commissioning with water. We submit these checks as a validation package.
  • Performance Qualification (PQ): This activity is for GMP compliance of system operating conditions during commissioning with an actual fluid. We support the customer with specific items and observe operations.

Scope

Equipment and electrical, instrument, monitoring and computer system, piping, HVAC, civil and architecture

Fields of application

This equipment is suited to customers in the pharmaceuticals production business.

  • Pharmaceutical plant overall, biopharmaceutical plant, chemical synthesis pharma-ceutical plant and drag formulation plant
  • Customers considering expansion to an overseas location
  • Customers for whom there is a requirement to submit an application and hold advance meetings with overseas regulatory authorities

Technology

Validation

Administration
We draft a validation master plan, and we make up a validation turnover package for the DQ, IQ and OQ plans and execution.
We execute items from a computer system validation (CSV) development manual to operational tests.
Overseas support business
We set and attend advance meetings with overseas regulatory authorities such as the FDA.
We support filings with overseas regulatory authorities such as the FDA.
We offer to support for Performance Qualification (PQ).
Scientific verification support
Fermentor and agitation tanks: we offer simulations for verifying the equivalence of pilot equipment and actual equipment. We execute scientific verification of containment of raw materials, intermediate substances, and products (containment systems, isolator and HVAC preventing biological or chemical hazards).