Support for Validation｜Toyo Engineering Corporation

Summary

The environment surrounding the pharmaceutical industry is changing each day on a global scale. In two areas, namely production processes and information systems, TOYO has experience in the support services for validating and configuring quality assurance systems that always conform to the latest regulations and guidelines.
These services constitute comprehensive support for validation that covers the entire lifecycle of your medical and pharmaceutical facilities and computer systems.

Our Business

TOYO is able to deal with the specialized industries, and offers the comprehensive support services related to validation involved with the entire lifecycle of systems, from product development to system configuration, operation and disposal.

Support service for facility validation

This comprehensive activity starts with facility planning and conceptualization and progresses along with the facility design and construction. TOYO offers a broad range of services for industries required to comply with GMP, such as the manufacturers of pharmaceutical products, quasi-drugs, diagnostic products and medical equipment.

Support service for computer validation

In accordance with the basic concept of computer validation that considers the entire system lifecycle from development to running, operation and disposal, TOYO offers consultation services for a wide range of areas, including production management, production management systems and PLC, facilities, human resources and SOP at worksites.

Support service for GXP

TOYO offers

Consultation services

Support for reconfiguration of companywide quality assurance manuals
Support for quality assurance system configuration
Support for reconfiguration of integrated factory-wide validation system
Support for computer validation
Audit of suppliers
Studies for dealing with electronic records and signatures in other countries

Summary of plans for seminar implementation and quality assurance system configuration

Summary of plans for quality assurance system configuration
Summary of inspection simulation for GMP
Summary of risk assessment
Summary of validation master plan
Summary of IQ/OQ/PQ implementation plans
Summary of supplier audit
Summary of computer validation tasks pursuant to GAMP5
Summary of validation summary report

Support for facility validation

GMP inspection simulation
Studies on GMP compatibility
Implementation of impact assessment and risk management
Preparation of VMP/VSR
Design review (DR)
Support for preparing IQ/OQ/PQ implementation plans
Support for IQ/OQ/PQ implementation

Support for implementing computer validation

Implementation of impact assessment and risk management
Preparation of VMP/VSR
Implementation of supplier audit
Design review (DR)
QPP preparation
Support for preparing IQ/OQ/PQ implementation plans
Support for implementing IQ/OQ/PQ

21 CFR Part11	Title 21 Code of Federal Regulations Part11	OQ	Operational Qualification
DR	Design Review	PDA	the Parenteral Drug Association
FDA	Food and Drug Administration	PQ	Performance Qualification
GAMP	Good Automated Manufacturing Practice	PV	Process Validation
GCP	Good Clinical Practice	QPP	Quality Project Plan
GDP	Good Distribution Practice	SOP	Standard Operational Procedure
GLP	Good Laboratory Practice	URS	User Requirement Specification
GMP	Good Manufacturing Practice	VMP	Validation Master Plan
ICH	International Conference on Harmonization	VSR	Validation Summary Report
IQ	Installation Qualification

Support for ValidationSupport service for configuring a quality assurance system