Discussion on the planning and implementation of new projects in pharmaceutical plants

[chinapharma.com Pharmaceutical Engineering] for pharmaceutical enterprises, in addition to product, technology, talent, capital and other factors, infrastructure and construction are also important factors, because good supporting facilities will not only affect the production of pharmaceutical products, but also affect the brand image of pharmaceutical enterprises Therefore, more and more pharmaceutical enterprises begin to attach importance to pharmaceutical plant projects, especially new pharmaceutical plant projects, including project planning, construction, maintenance, management, etc If the pharmaceutical enterprises have the intention to build a new pharmaceutical factory project, they need to start from planning and planning, and find a pharmaceutical engineering team Relevant experts said that in the planning stage of the new pharmaceutical plant project, market-oriented factors should be considered more comprehensively In general, pharmaceutical enterprises need to consider these factors, such as demand analysis, production process and strategy, project location, technical concept, environmental awareness, health and safety, facilities, public works and equipment, current regulatory requirements, documentation, restrictions, time and progress, project cost estimates, etc In terms of demand analysis, for a new pharmaceutical plant, a successful project should have identified the demand at the beginning of the project "In theory, the drug registration process largely determines the commercial manufacturing process of drugs Therefore, the design focus of the new pharmaceutical plant project is not the research and development of pharmaceutical manufacturing process Based on this concept, what pharmaceutical companies should do is to make pharmaceutical engineers understand the registration process of drugs as soon as possible " A pharmaceutical engineering expert said When the demand is determined, pharmaceutical enterprises and pharmaceutical engineering parties shall formulate the feasibility study report, business plan of production base project, construction conditions and site selection for the new project of pharmaceutical plants Determine the organizational structure and form of the project department, coordinate with the functional departments of the company to select and appoint the main members of the project department, and effectively carry out the project work Organize project kick-off meeting, work out project tasks, project schedule / expense control plan and cost control plan For example, the construction manager is mainly responsible for establishing the site construction management organization system, determining the personnel and positions of the site construction management team, and organizing the construction management personnel to enter the construction site when the site construction conditions are met; QA / QC manager of the project shall abide by and implement relevant national and industrial standards, and carry out technical and quality work under his leadership The HSE manager shall assist the project manager to prepare the project HSE plan, determine the major hazard sources and HSE objectives of the project, and formulate the project HSE management system plan; the construction personnel shall carefully prepare the production plan and construction scheme, and organize the implementation of the construction process, quality and safety technical measures; The quality controller shall also conduct the acceptance and review of concealed works in time, and assess the quality level of sub divisional and sub divisional works according to the quality assessment standard to ensure the completeness, authenticity and accuracy of the project It is worth mentioning that after the completion of the pharmaceutical project, the project department should contact the relevant government departments for the acceptance of the project, including the acceptance of environmental protection, health, fire protection, planning, etc Only when the division of labor is clear, can each perform his or her duties to help the new pharmaceutical plant project go smoothly In order to make the project more in line with the standards and regulations, pharmaceutical companies need to carry out the validation work plan for the project The project director of a pharmaceutical enterprise said: "in order to meet the requirements of product quality and laws and regulations, pharmaceutical enterprises should apply risk assessment methods to new pharmaceutical projects in each stage of validation, analyze the characteristics of each stage of validation; carry out risk assessment in each stage of validation in accordance with the time sequence; use risk assessment methods to determine the scope and extent of validation." Generally speaking, the whole new pharmaceutical plant project roughly includes these elements and processes, i.e equipment list, impact assessment, user's demand description, design specification, GMP design review, design confirmation, procurement and construction, installation and operation performance confirmation, and completion acceptance From planning, planning to implementation, project construction, pharmaceutical enterprises and pharmaceutical engineering should do a good job Pharmaceutical enterprises should think about the project-based active management mode, and look for good production conditions and product quality assurance process from the perspective of patients And pharmaceutical engineering also needs to stand in the perspective of pharmaceutical companies to determine their needs, only in this way can the whole project be completed quickly and put into production.