The First Challenge in Initiating Clinical Trials of Radiopharmaceuticals in Japan
When initiating a radiopharmaceutical clinical trial in Japan, the first major challenge is establishing a GMP system for investigational drugs, which involves:
- Addressing the unique requirements of short-half-life products
- Establishing a rapid quality evaluation and product release process
- Integrating radiation safety requirements with GMP operations, facilities, and working environments
- Responding to audits
These challenges are unique to radiopharmaceuticals. Without an appropriate GMP system that is properly established and maintained, efficient initiation and operation of clinical trials can be difficult.
Micron offers comprehensive support to overcome these challenges.
Our GMP Support Solutions to Address These Challenges
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Preparation for Clinical Trial Initiation
GMP System Establishment Support
- Development and organization of the GMP documentation system
- Design of a quality assurance framework
- Design and implementation of deviation, change control, and CAPA management processes
Audit Support
- Support for meeting GMP compliance requirements set by academic societies
- Assistance with sponsor (clinical trial applicant) audits
- Support for corrective actions in response to audit findings
Technology Transfer Support
- Transfer of manufacturing processes
- Transfer of analytical/testing methods
- Support for conducting three-lot process validation
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After Clinical Trial Initiation
Manufacturing and Operational Support
- Support for manufacturing management and QA/QC operations
- Establishment of an equipment and facility management system
Audit Support
- Support for meeting GMP compliance requirements set by academic societies
- Assistance with sponsor (clinical trial applicant) audits
- Support for corrective actions in response to audit findings
RI (Radioisotope) Sales Operations Support
Why Micron’s Support Enables Clinical Trial Start-Up and Ongoing Operations
Our GMP support goes beyond the mere establishment of a formal system.
Taking clinical trial initiation schedules into account, we organize the roles of the sponsor, manufacturing facility, and medical institutions, and support audit readiness from the sponsor’s perspective.
This approach enables the establishment of an investigational drug GMP system that completes clinical trial start‑up preparation and allows for continued support after trial initiation.
Solutions
Contact Us
If you are considering investigational drug GMP setup support, please feel free to contact us.
Please feel free to contact us
We provide comprehensive, end‑to‑end clinical development support, with imaging at its core.
With more than 20 years of experience, our team of imaging specialists in Japan and around the world tackles the complex challenges of imaging evaluation in pharmaceutical and medical device development. We deliver optimal, project‑specific solutions for each client.