CM Plus responds to clients’ needs with top-level expertise and technical capabilities in the construction of production facilities in the fields of pharmaceuticals, medical devices, and more. From sterile pharmaceuticals to active pharmaceutical ingredients, regenerative medicine, and medical devices, we have been meeting numerous needs since our founding, from the business planning stage to basic design, construction, and IQ/OQ phases.
We flexibly respond to client situations, not only for new construction, but also for expansion, relocation, partial renovations, and technology transfer.
Sector Details
Our services range from pharmaceuticals (sterile pharmaceuticals, oral drugs, active pharmaceutical ingredients, vaccines, biopharmaceuticals, investigational drugs, and diagnostics) to medical devices, regenerative medicine, and cell therapy.
We also provide a wide range of services from R&D facilities to clinical trials, pilot plants, and commercial production.
Features
The pharmaceutical and medical device sectors deal with products that directly impact human health, thus requiring stricter quality control than other products. The characteristics of manufacturing facilities include:
- Compliance with GMP is required (PIC/S, cGMP, EU-GMP, and GMPs of various countries).
- Advanced environmental control (cleanliness management, temperature and humidity management, room pressure management, pharmaceutical water management, etc.) is necessary.
- Advanced hazard management (chemical hazards, biohazards), management of hazardous materials, and management of poisons/narcotics may be required.
- Since the production equipment and the building/architectural facilities need to function as a cohesive unit, complex integrations between them arise.
- Proper commissioning and qualification (C&Q) based on accurate risk analysis are required.
Keys to Success
How to Ensure the Success of Construction Projects in the Pharmaceutical and Medical Device Sectors:
- From the early planning stages, proceed while consciously including GMP compliance and validation at each step by confirming specifications accurately.
- Conduct appropriate architectural and equipment design to control environments and manage hazards, ensuring accurate pathways and containment plans.
- Ensure the coordination between production equipment and building/architectural facilities.
At CM Plus…
- We start Commissioning & Qualification (C&Q) from the basic design stage to ensure quality compliance, including GMP. Trust us with validation management as well.
- Leveraging our extensive experience and specialized knowledge, we derive and propose the optimal plan for our clients.
- By coordinating the detailed physical integration of production equipment and building/architectural facilities at the drawing stage, we minimize rework at the construction site.
- We plan and manage the project master schedule, including design and fabrication management of production equipment and coordination of delivery plans.
Construction Project Flow of the Production Facilities
We will explain in detail the workflow for each project phase.
Related Contents
Useful Information
Please refer to the articles on our information dissemination site, “GMP Platform,” which is operated by our company.
