GCTP Consulting
GCTP Consulting
For manufacturing control and quality control of regenerative medicine products, we provide support from reviewing your current state to improvements and the development of facilities and operations.
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01What Is GCTP?
GCTP is the standard for manufacturing control and quality control of regenerative medicine products. It covers manufacturing sites, manufacturing processes and quality control, not nonclinical studies themselves.
We support improvements to facilities, documents, training and operations aimed at GCTP compliance at regenerative medicine product manufacturing sites.
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02Gap Analysis of Requirements vs. Current State
We map the gaps between the requirements of laws, regulations and guidelines and your current facilities, documents and operations.
Based on the results, we propose prioritized improvements and how to implement them.
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03Developing GCTP Documents and Training Systems
We support building, reviewing and strengthening the systems side, such as GCTP documents.
Aiming for systems your on-site teams can actually run, we support regulatory training and the development of training plans.
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04CPC Planning and Facility Improvement
We support the basic design of cell culture facilities (CPC: Cell Processing Center) to help create GCTP-compliant facilities.
We analyze existing CPCs in terms of both facilities and operations, and support the necessary improvement proposals and their implementation.
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05Improving and Embedding Compliance
We support improvements to the issues identified, across documents, training, facilities and operations.
Where needed, this leads on to audit support and building a quality management system that looks across all of GxP.
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06Related Support for Your Challenges
Beyond GCTP support alone, we combine related services to fit your challenges, covering development and regulatory affairs, CMC, facilities and equipment, audits, and CSV and DI.
For questions or consultations about our services, please call us or use the contact form.
Hours: weekdays 9:00–18:00 (JST)
Contact
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