EPCM project management

The construction of pharmaceutical facility, with large investment and long cycle, is an important event for the long-term development for a company. It is important to avoid project quality problems or even GMP compliance problems caused by the poor construction quality and poor project management from construction contractor.

The company’s investment is based on its long-term development plan. Due to the trend of integration of domestic pharmaceutical industry with global standards, the construction projects should meet the global standard of technology and regulations. The rapid improvement of Chinese GMP compliance and product registration requirement are the new challenges to the domestic enterprises. It will require domestic pharmaceutical enterprises to plan their future business with new strategy. In order to fast reach to global standard, the domestic companies must comply with the trend of global pharmaceutical industry, broaden their development opportunities in domestic market. That will also improve company’s image in drug product market and bring real benefits for the company. It is significantly meaningful for the company’s current development and also for long-term goals. 

The construction of pharmaceutical facility is a complex project. Its basic contents include project planning, design, equipment selection, construction management, operation and project acceptance. When carrying out a facility construction project, the hardware, such as equipment and facility, must be completed simultaneously with operation personnel training, setting up management system, establishing GMP document system, verifying operation system, implementing technology transfer of products and submission for approval. These tasks must be well organized and carried out synchronously. Otherwise, the goal of successful project completion, facility certification and smooth manufacture operation cannot be achieved. The facility construction project needs to adopt professional management methods to ensure the quality of construction project and compliance with GMP requirements. That will achieve all objectives of construction project.

Through the formation and improvement of project management and standard implementation, a full set of systematic project implementation and management system is established for the project construction and management.

Throughout the planning of project system, we establish a detailed project implementing plan, including pre-project planning and facility design, equipment selection and procurement, a validation system, GMP filing system, and product technology transfer and approval system to ensure that the construction project will be high efficiency, completion on time and budget control.

Project management needs a series systematic management methods. The project construction management system which is established in accordance with GEP system can precisely control the quality of construction process, schedule and cost. Scientific management methods and mature management processes and tools can ensure the safety of the construction process in accordance with GMP requirements. That will help the completion of validation and confirmation of the construction process.

Project management

GEP project quality management -- project construction management standards:

> Overall program of project management and project implementation;

> Project URS (user required standard);

> Project budget control;

> Project construction technical scheme;

> Project validation master plan;

> Project filing system establishment and filing management control;

> Project equipment control, including the whole process control from equipment selection, procurement to installation confirmation;

> Project installation confirmation filing;

> Project construction management procedures and process control standards;

In order to ensure the realization of all aspects of the project construction goals, including reasonable planning and correct equipment selection and to achieve the project budget control, the careful planning and effective construction process management are necessary to realize the construction process cost control. Through scientific design and a GMP system, the operation cost can be optimized. We will carry out risk assessment in the whole construction process and ensure the facility to reach the global quality standard and meet the European and American GMP requirements.