Procedures for the establishment of a new plant: market research → project → project plan → site selection → design → built → evaluation → acceptance → use.
Establishment: the work before the establishment of the project is generally referred to as the pre-project (mainly including project planning, feasibility studies, preliminary design, etc.), the work after the establishment of the project is generally referred to as the implementation of the project (mainly including the construction drawings and design, bidding, contracting, purchasing, construction and completion of the acceptance, final accounts and post-project evaluation, etc.). Due to the differences in the subject of investment, the industry of investment, the scale of investment, and the nature of the project (profit and non-profit, etc.), the government has different regulations for project approval. According to the aforementioned elements, investment projects are divided into four categories: prohibited, restricted, licensed and encouraged. Except for the prohibited category, which does not allow construction, the rest are subject to an approval system, an authorization system and a filing system, respectively. The stage of approval of their projects, the information required to be submitted for approval, and other administrative licenses that should be obtained before approval are different. For the preparation and construction of pharmaceutical factories must comply with national regulations.
The plan is divided into two: one for government departments to review, that is, the research report. One is to the plant to build the actual operation of the plan arrangements, that is, the project plan, this should have a major arrangement and specific project plans (including financial aspects), the purpose of the project, each phase of the project to do the specific work, to build the internal coordination, external coordination with government departments and related regulations, acceptance specifications, the plant each unit design, the details of the design can be written separately URS (Preparation for the construction of the GMP plant) (Preliminary preparatory work)
I. Establishment of the project, investment and construction of the party's desired objectives:
(I) Procedures
1 , the applicant should be to the proposed enterprise location of the provincial drug supervision and management department to submit an application. Within 30 working days, in accordance with the industry development plan and industrial policy to review and make a decision on whether to agree to the preparatory work.
2, the sponsor to complete the proposed enterprise construction, should apply for acceptance to the original approval department. Production of injectables, radiopharmaceuticals and biological products under the State Council drug supervision and management department of the certification of drug manufacturers, the State Council drug supervision and management department is responsible for.
3, acceptance, issued by the "Drug Manufacturing License".
4, the new start-up drug production enterprises, drug production enterprises, new drug production plant or new production of dosage forms, should be obtained from the production of drugs within 30 days from the date of certification or approval of formal production. (Application for production approval of products)
(2) scale
1, site selection (land purchase or lease)
2, near-term planning and visionary planning
3, the production of what products
4, what is the expected scale (i.e., the daily production volume)
5, according to the formulas and process requirements for the construction of the plant
Two, determine and Formation of leading organizations
1, the establishment of GMP leading group.
2, hardware and software:
Generally there is a general manager (investor) and two project managers, the two are responsible for the hardware (i.e., project engineering and equipment and facilities system); one is responsible for the software (i.e., the GMP office), respectively, under the various functional departments or persons in charge. (GMP certification and software part can also be entrusted to qualified consulting firms.)
3, personnel recruitment, training
Three, according to the intentions of the investor, the approval
Apply for the entire process of preparation for the various types of licenses required for the preparation of the declaration of data preparation, approval and approval of the work, to the relevant departments for review and supervision. Including the competent pharmacological supervision department, co-management of the departments are: water, electricity, gas, communications, fire, urban construction, environment, etc., the supervision of the department of fire, Safety Supervision Bureau, Technical Supervision Bureau.
Four, production process
Five, the purchase of equipment, facilities, instruments, etc.
Six, to determine the construction program, the organization of the program and the implementation of the project