Since its foundation, CM Plus has been working for a number of life science-related projects thus developed the first-rate knowledge and skills. We ensure and maintain quality not only for GMP compliance in designing and construction phases but also for Commissioning & Qualification activities which start from the early designing phase. We also establish various supporting structures such as a tie-up with consultation till the process of supporting inspections after launch. CM Plus guides your construction project to success through those efforts.

In life science industries, products which may affect human health are handled. Therefore, quality control required for the products needs to be more strict than that for other types of products. Characteristics of manufacturing facilities are as follows:

• Compliance with GMP is required. (PIC/S, cGMP, EU-GMP and local GMP)
• Advanced environmental control (cleanliness control, temperature and humidity control, room pressure control, manufacturing water control, etc.) is required.
• Advanced hazard control (against chemical hazards and biohazards) and poisonous material/narcotics control may be required.
• Complicated coordination is required as production equipment and facilities, and buildings and their facilities function together.

Commissioning and Qualification (C&Q) activities are required to be implemented based on accurate risk analyses.

The following diagram shows the flow of Commissioning & Qualification activities.