How To Do A Good Job In The Management Of Pharmaceutical Factory Construction Projects?

When investing in the construction of a pharmaceutical factory, people hope that it can not only meet the requirements of laws and regulations, but also fully meet the production needs. In addition, the appearance should be pleasing to the eye. However, there are multiple classifications within the pharmaceutical industry, so some pharmaceutical factories have to adopt chemical industry standards, some have to adopt food industry standards, some have to adopt pharmaceutical industry standards, and some will need to comprehensively consider multiple standards. Therefore, in order to build a satisfactory pharmaceutical factory, there must be sufficient technical support in every link, and multi-party demonstrations; managers must also have rich experience and theoretical foundations in construction engineering to carry out strict and standardized construction. manage. The author has been responsible for the management of more than a dozen construction projects. In this article, the whole process of pharmaceutical factory construction is analyzed, and the key points and precautions for successful construction are summarized. I hope that colleagues can gain something after reading it.

Part 1 The Lcation Of The Pharmaceutical Factory

To build a pharmaceutical factory, it is first necessary to clarify the type of drug produced: is it raw material medicine, solid preparation, biological vaccine or traditional Chinese medicine preparation? The production processes of different drugs vary greatly, and the requirements for plant areas and equipment are also different. After determining the types of drugs to be produced, the first thing to do is to choose the location of the factory. The choice of factory site not only needs to consider the requirements of GMP (Good Manufacturing Practice), but also needs to consider the requirements of electricity, energy consumption, and environmental protection. In addition, it is necessary to understand the local labor costs, infrastructure costs, land prices, topographic and geological conditions and The local government’s attitude towards construction project supervision. Only if these details are taken seriously, the quality, schedule and cost of the project will not be affected.

Part 2 Design Of Pharmaceutical Factory

“A good product is designed.” The design of a pharmaceutical factory is crucial to the construction of the entire project. In order to build an ideal project, the process department and the quality department must participate in the whole process of the design stage. The process department must clarify the process route and technical indicators, and then the quality department will review. The design unit can carry out the preliminary design only when the technological conditions are complete, and the level of the design unit can be checked by the depth of the preliminary design. The author recommends appointing a qualified professional design institute for design, which can effectively avoid defects. In addition, other departments of the pharmaceutical company also need to participate in the design to determine the factory style, financial investment and other matters.

The main responsibility of the infrastructure department at this time is to fully communicate with the designers about the company’s design needs, and to grasp the design plan and progress; at the same time, consult and communicate with the local planning, fire protection, environmental protection, safety supervision and other departments to ensure that the preliminary design drawings can be approved . Engineering and technical personnel in the infrastructure department must master the three principles of “compliance, practicality, and economy” in design, and especially review the coefficient of design redundancy, which should not be too large. Attention should be paid to the size and steel content of the building structure (columns, beams), which are the culprits that cause excessive infrastructure costs. After the preliminary design drawings meet the requirements of the pharmaceutical factory, the design contract will be signed. The contract content includes the depth of the construction drawing, service cycle, calculation and estimated budget, and design costs. After the construction drawing is completed, experienced personnel should be organized to conduct a joint review of the drawing, and carry out detailed decomposition according to the specialty. Reviews are detailed enough that design changes and approvals during construction can be reduced or eliminated. The author has completed 3 projects with a completed area of 100,000 m2 and a construction cost of 350 million yuan, but the total change and visa fees were less than 2 million yuan. This is all due to the careful review during the joint review stage of the drawings . In addition, the technicians responsible for infrastructure construction must master sufficient technical specifications (process, equipment, construction, fire protection, water supply and drainage, electricity, purification, pipeline installation, decoration, environmental protection, and safety, etc.), and also have production, equipment After the process department has determined the equipment layout, it is necessary to know how much auxiliary equipment should be equipped, such as pipelines, electric power, and automatic control. Rich experience is the basis for infrastructure technicians to participate in joint review of drawings.

Part 3 Construction Of Pharmaceutical Factory

Before the construction of the engineering project, it must be reported to the government department and be supervised. In this process, professionals need to communicate with various departments. The departments involved include planning, land, fire protection, environmental protection, construction committee, electric power, Heat or gas and municipal etc. Generally speaking, it takes about half a year to a year for an industrial project to obtain a construction permit. Therefore, at this stage, relevant personnel are required to have both patience and the ability to tackle key problems.

After obtaining the construction permit, the project can start. It should be noted that construction in advance is not only a violation of regulations, but also because there is no construction permit, the quality supervision department will not conduct inspections in time, which will result in insufficient acceptance of sub-item materials during the construction process; in addition, it cannot be processed without a construction permit Completion procedures. When bidding, pharmaceutical companies must strictly inspect the qualifications, performance and reputation of the construction unit. When making project budgets, we should not blindly pursue low prices, but be reasonable and fair.

In the construction stage, the main body of the construction is the construction unit, and the main work of the infrastructure department is on-site management. The infrastructure department should strictly review the construction organization design plan to prevent the construction unit from merely copying the plans from other places without combining the actual situation of the project; in addition, it should maintain communication with the technical personnel of the construction unit to grasp key nodes, steps and special construction methods .

The construction phase is divided into four phases: main building construction, decoration, equipment installation and ancillary facilities construction. In order to ensure the quality of the project, the cross-construction in the first three stages should be avoided as much as possible; if cross-construction must be carried out, the connection of each process must be done well, and the responsible party for the protection of the finished product should be determined. Strict quality inspection should be carried out on the construction site: during the main construction, special attention should be paid to whether the specifications and quantities of steel materials, the grade of cement, and the construction method of concealed works are in compliance with the specifications. During the decoration process, we must be alert to the phenomenon that the floor drain is higher than the ground during the ground construction, especially when the ground is laid with PVC coils, epoxy resin self-leveling floors, etc., it must be treated before construction; in addition, it is necessary to Beware of problems such as poor sealing of the window frame (between the window frame and the wall) and poor adhesion of the waterproof corners of the roof, which will cause water seepage in the pharmaceutical factory in rainy days and make maintenance difficult; color boards, especially corridor side boards, are the best Install after all internal work is complete to avoid bumping. At the equipment installation stage, attention should be paid to the safety and protection during the equipment installation process. During the construction of auxiliary facilities, the inspection wells of the outdoor pipelines in the factory area should be avoided as much as possible on the road. This work is generally ignored by the technicians during the joint review of the drawings, but the second design of the drawings can be carried out according to the actual situation on the site before construction. , which is not only conducive to improving the aesthetics of the factory area but also facilitating road construction. Finally, it should also be checked whether the construction personnel are recording and signing on time during the construction process. The technicians of the infrastructure department should participate in the analysis meeting of construction and quality supervision, keep abreast of the problems existing in the quality, progress and safety of the project, and check and sign the changes of drawings and project quantity negotiations that occur on site.

Part 4 Closing And Delivery Of Pharmaceutical Factory Construction

The closing stage of the project begins with the trial operation of each system, and ends with the handover of the project to the pharmaceutical factory for acceptance. During this period, all buildings, equipment, facilities, construction materials, equipment manuals, test reports, sub-item acceptance sheets, as-built drawings, etc. need to be registered and recorded, and handed over after checking one by one. This work is very important, firstly because these materials need to be submitted for completion procedures and real estate certificates; secondly, because these materials can be used to verify what level the completed project has reached, whether it is excellent, pass or fail; thirdly, because it It can leave a complete set of information in the drug factory, which is convenient for future maintenance and transformation. In addition, the final account of the project must be carried out at the closing stage, and the final account should ensure fairness and justice. At the same time, the Ministry of Infrastructure should prepare a project summary report, including the difficulties encountered in the stages of preliminary preparation, design, filing, contract, construction quality and progress, and acceptance, as well as the highlights and improvement points in the project work. The Ministry of Infrastructure should summarize the experience and lessons learned in the management of this project, and pay attention to the innovations and reforms in the project implementation process; if there are innovations and inventions, it is best to submit them in the form of papers.

The work in the completion and delivery stage is relatively easy, mainly to cooperate with the production, quality, and equipment departments to verify; if the previous data are detailed and accurate, then they can be compiled into documents during this period. Then hand over the sorted files to the competent department, complete the completion filing at the construction committee, and then you can wait to receive the real estate certificate.

The construction of a pharmaceutical factory is a complex project. From project approval to delivery, management personnel need to devote a lot of energy and encounter various difficulties. Therefore, only by doing everything by yourself and doing a good job in every link can we leave no flaws and regrets .