Introduction to Famo Yoko Certification Consulting Services

Enterprises related to the business of Fuzhou Famo Youke Machinery Technology Co., Ltd. include pharmaceutical, food, cosmetics, medical and other production enterprises, major hospitals with preparation rooms, and higher vocational colleges that need to build student training platforms, training centers, training bases, training workshops and training rooms. Newly-built production enterprises need to carry out site selection, planning, design, civil construction, equipment and instrument purchase, purification engineering construction, organization setting, personnel training, quality management system construction, various verification and implementation, product trial production, production license application and GMP certification. The original production enterprises need to be upgraded, including the relocation and transformation of the plant, the upgrading of equipment, the adjustment of the organization, the retraining of personnel, the improvement and even reengineering of the quality management system, the change of production license, and the re-certification of GMP. Hospital preparation rooms need to be redesigned, constructed, and upgraded to meet increasingly stringent regulatory requirements. Higher vocational colleges with majors in pharmaceutical engineering, pharmacy, pharmacy, bioengineering, food quality and safety all need to build student training platforms, training centers, training bases, training workshops, and training rooms. We provide The overall solution, from early site planning, process design, equipment selection to equipment installation, civil construction, GMP decoration to later certification services, personnel training, etc. The work of the above-mentioned units is regulated by corresponding laws and regulations, and all the work is complicated and complicated. And with the increasingly stringent regulatory standards, a variety of new regulatory requirements emerge in an endless stream. Fuzhou Famo Youke Machinery Technology Co., Ltd. is committed to the overall construction of pharmaceutical, food, cosmetics and other related projects, providing one-stop solutions and realizing turnkey projects. We focus on every process and detail of the project, from the early overall planning, process design, equipment selection to the project civil engineering, GMP decoration, GPP material preparation, certification, personnel training and other aspects of the whole process to provide customers with efficient and professional services. Help enterprises to meet the basic conditions of production (or operation), to obtain the corresponding license and GMP certificate (or GSP certificate), this is only our minimum requirements. On this basis, through our services, we can improve the efficiency of enterprises, shorten the preparation time of enterprises, improve the quality of enterprise personnel, reduce the direct input of enterprises, save the operating costs in the future, so as to improve the efficiency of enterprises from all aspects. Specifically, our services can bring the following benefits to enterprises: 1. With rich practical experience in enterprise management and good contacts with supervision departments, we can formulate perfect work plans for enterprises, save time and improve the success rate of all kinds of certification! 2. check the hardware construction of the enterprise, reduce the mistakes in the hardware construction, build the hardware that best meets the needs of the enterprise with the least money, and buy the equipment that best meets the needs of the enterprise! 3. Establish a set of GMP (or GSP, SC) management documents in line with the characteristics of the enterprise, which can carry out daily management according to the requirements of the documents and has the feasibility of practical operation. 4. Bring new management concepts to enterprises and provide successful reference cases!

GSP Certification Consulting Services

For the hospital preparation room, the GSP specification of drugs runs through the whole process and all aspects of pharmaceutical production management. Fuzhou Famo Youke Machinery Technology Co., Ltd. is a professional preparation room overall solution service provider. For hospital preparation drugs, it can strictly follow the relevant provisions of the "Drug Business Quality Management Standard" (GSP), and provide full-process verification services for drug storage equipment facilities and temperature and humidity automatic monitoring systems. Fuzhou Famo Yoko Machinery Technology Co., Ltd. provides you with comprehensive GSP certification consulting services. The services include:

SC Certification Consulting Services

SC is the Chinese phonetic abbreviation for "production" and, like QS, is a production license. According to the "Administrative Measures for Food Production Licensing" that came into effect on October 1, 2015, it is clearly stipulated that newly certified food producers no longer use the QS mark, and the "SC certification" replaces the original "QS certification". The SC certification process is the "Food Production License" processing process. SC certification is more stringent than QS certification requirements, the process is more complex!

GPP Certification Consulting Services

As the country attaches importance to the development of the pharmaceutical industry and the healthy living needs of the whole people, the management and policy requirements for hospital preparations are also constantly improving. In 2000, the country implemented the "Good Preparation Preparation Quality Management Regulations for Medical Institutions" (Practice abbreviation GPP), which was formulated according to the provisions of the the People's Republic of China Drug Administration Law and the basic principles of the Drug Production Quality Control Regulations, the main aspects of the preparation of medical institutions, such as the preparation environment and equipment requirements, health management, standard operating procedures, quality inspection and other aspects of the provisions. This specification is the basic guideline for the preparation and quality management of medical preparations, which is applicable to the whole process of preparation, and is mainly formulated for all factors that may affect the quality of preparations. Fuzhou Famo Youke Machinery Technology Co., Ltd. is committed to the overall solution of the preparation room, including GPP certification services for the hospital preparation room. The following are the main contents of the service: 1. provide all kinds of documents in accordance with the latest regulatory requirements; 2. guide the inspection of production process of equipment, instruments, workshops and products; 3. guide and participate in the training of the personnel in the preparation room; Collate and summarize all kinds of 4. files (including equipment and instrument files, supplier files, training files, self-inspection files, etc.); In addition to the following value-added services to choose from: 1. Guide Party A to select qualified material suppliers and guide the specific production process; 2. Guide Party A to set up the organization of the preparation center and allocate all kinds of personnel; 3. Responsible for guiding Party A to formulate annual training plan, providing complete training materials (including training plan, training materials, training questions, training lecturers, etc.), and responsible for the training of pharmaceutical laws and regulations and major management projects. 4, responsible for the preparation of a complete set of GMP-compliant documents and technical information; 5. Responsible for guiding Party A to complete all kinds of verification work, including equipment verification, inspection method verification, cleaning verification, process verification, etc; 6, responsible for guiding Party A to complete all kinds of records to fill in the work. 7. Be responsible for guiding Party A to complete the sorting and improvement of various files (provide a full set of templates). 8. Be responsible for guiding Party A to prepare the application materials of "Medical Institution Preparation License" according to the new laws and regulations, until the "Medical Institution Preparation License" is obtained. 9. Before the formal on-site inspection, organize 2-3 experts to conduct a simulated inspection of Party A's preparation and put forward rectification opinions. 10. After the on-site inspection, Party B shall guide Party A to prepare the rectification materials of defective items.