Conditions for the preparation of a pharmaceutical plant
Condition 1: with the qualification of pharmacy technicians, engineers and corresponding skilled workers according to law;
Condition 2: with its pharmaceutical production compatible with the plant, facilities and sanitary environment; In addition, we should know is that the GMP workshop is a must for the pharmaceutical plant, the GMP dust-free workshop design, manufacturing, installation, commissioning can be done by a third party team, such as CIO Compliance Assurance Organization to provide assistance in this regard.
Condition 3: Have the organization, personnel, and necessary instruments and equipment to carry out quality management and quality inspection of the medicines produced;
Condition 4: Have the rules and regulations to ensure the quality of medicines.
Pharmaceutical plant construction process (for reference only, should be subject to local policy announcements)
The first step: the project proposal to report to the Development and Reform Commission, apply for project funding and determine the content of the construction;
The second step: site selection, application for planning, land acquisition, in the development of the Commission to take the red line map, the main points of the planning and reporting requirements, and a variety of technical information (including geological, hydrological, meteorological, traffic, transportation and other technical information).
Step 3: Prepare a feasibility study report, environmental assessment report, and report to the relevant departments;
Step 4: General planning and design, monolithic architectural design, reported to the planning department for approval;
Step 5: GMP program design, reported to the GMP certification center of the Provincial Pharmaceutical Administration for review or record;
Step 6: geological departments to conduct a geologic survey, and a detailed geological report;
Step 6: Geological departments for geological survey, and a Step 7: equipment purchase and bidding;
Step 8: construction plan design, civil engineering and steel structure bidding;
Step 9: construction plans reported to the municipal plan review office, audit, hire construction supervision (according to the case of hiring the project management);
Step 10: the steps of the various departments of the management, you can go to the window service point of the local government to obtain the procedures; the above procedures. Point, for procedures; the above procedures involve departments are probably construction management (including water, electricity, communications, etc.), land departments, drug supervision departments, environmental protection departments, engineering quality inspection stations, planning departments, fire departments, and other departments such as the Economic Commission for the record;
Eleventh step: civil construction, installation project bidding and construction, commissioning, test production, acceptance, certification, by the project management staff responsible for; (Acceptance is divided into a number of, quality inspection station, environmental protection, fire and so on)
Twelve steps: to meet the production conditions after the production of the test product to apply for registration of pharmaceutical packages, first reported to the Provincial Bureau, through the on-site verification by the Provincial Bureau reported to the National Bureau.
Step thirteen: the certificate of registration of pharmaceutical packages and supplemental application for approval to get after the application for GMP certification.
Well, the above is about the process of building a pharmaceutical plant and the conditions, in general, the construction of the pharmaceutical plant is not simple, and the procedures are very cumbersome, with the help of professional third-party project consulting firms (such as the CIO Compliance and Assurance Organization), you can intervene in the whole process to provide the whole process of consulting services for the enterprise, so that the pharmaceutical plant construction project in an orderly way to promote the rapid progress of the project, half the effort.
The CIO Compliance Assurance Organization (CIO), which focuses on the science of pharmaceutical regulation, has constructed a service system for all core aspects of the full lifecycle of product development, clinical research, registration, production, distribution, use, adverse reactions, and pharmacovigilance in the fields of pharmaceuticals, medical devices, cosmetics, and healthcare foods, and has provided services in the areas of auditing, consulting, training, and certification for the local pharmacovigilance authorities, We provide high quality services to local drug regulatory authorities, enterprises, investors, practitioners and so on.