Governance
Quality Management – Shin-Yokohama Facility
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Quality Management
At the Advalife Science Shin-Yokohama Facility we carry out manufacturing and the associated quality management and testing. The cell processing centre (CPC) within the facility has been accepted by notification as a facility for the manufacture of specified processed cells under the Act on Securing Safety of Regenerative Medicine, and has been assigned a facility number. Its laboratory function is accredited to ISO/IEC 17025:2017.
Contents
01
Quality management at Shin-Yokohama
03
ISO/IEC 17025:2017
02
Cell processing facility
Contents
01
Quality management at Shin-Yokohama
02
Cell processing facility
03
ISO/IEC 17025:2017
Quality Management System
Quality management at the Shin-Yokohama Facility
The Shin-Yokohama Facility operates under defined procedures, records and lines of responsibility for manufacturing and for the quality management and testing that go with it. Quality attributes, reproducibility, traceability and the reliability of the data matter to us, and the information arising from manufacturing and testing is managed accordingly.
Cell Processing Facility
Facility for the manufacture of specified processed cells
The cell processing centre (CPC) within the Shin-Yokohama Facility has been accepted by notification as a facility for the manufacture of specified processed cells under the Act on Securing Safety of Regenerative Medicine. In accordance with that Act, the premises, equipment, procedures, records and management arrangements required for manufacturing and quality management are in place and operated under appropriate control.
Facility number
FC3220187
Registered facility name (Japanese)
一般社団法人Advalife Science CPFクリニック バイオテックラボ
Date of acceptance
6 February 2023
Governing law
Act on Securing Safety of Regenerative Medicine
Category
Facility for the manufacture of specified processed cells
Source: registration information on e-Saisei Iryo, the Ministry of Health, Labour and Welfare’s online portal for applications and notifications relating to regenerative medicine.
ISO/IEC 17025 Accreditation
ISO/IEC 17025:2017 accreditation
Standard
ISO/IEC 17025:2017
Accreditation body
Perry Johnson Laboratory Accreditation, Inc.（PJLA）
Accreditation number
129309
Valid
7 May 2025 – 31 August 2027
Facility
Advalife Science Shin-Yokohama Facility
Scope
Chemical Testing (individual tests are listed in the scope supplement to the certificate)
ISO/IEC 17025 accreditation concerns the competence, impartiality and consistent operation of a laboratory within the accredited scope. It does not mean that any product itself has been approved as a pharmaceutical product or certified as a product, that the manufacturing process as a whole is GMP-certified, or that safety or efficacy is guaranteed.
Relationship with NOVARK BIO
The Shin-Yokohama Facility described on this page is not the same as NOVARK BIO’s pharmaceutical manufacturing site. For pharmaceutical manufacturing, GMP and CMC at NOVARK BIO, see Manufacturing & CMC.
QUALITY & GOVERNANCE
Enquiries about the Shin-Yokohama Facility and quality management
We welcome enquiries about manufacturing and quality management at the Shin-Yokohama Facility, about testing, and about our ISO/IEC 17025 accreditation.