Technical · Service
- Categories:Technical Services
- Time of issue:2020-10-22 13:03:21
Kaifeng Red Maple Leaf Biological Technology Co., Ltd. production research and development
1. Enterprise Overview
Kaifeng Hongfengye Biological Technology Co., Ltd. is a private joint-stock company established on December 22, 2004. It is located in the Gulou District Industrial Park, Kaifeng City. The factory covers an area of 23,310 square meters and a building area of 11,140 square meters. The production workshop area is more than 3456. Square meters (including 2500 square meters of clean production area), quality inspection center area of 306 square meters, storage area of 4956 square meters, and office building area of 2,200 square meters. It mainly produces 5 dosage forms including tablets, hard capsules, soft capsules, powders and granules.
The company has passed the certification of good manufacturing practices for health food; ISO9001 quality management system certification; ISO14001 environmental management system certification; ISO18001 occupational health and safety management system certification; ISO22000 food safety management system certification and HACCP certification. Belongs to China's health food export production enterprise, and has obtained the right to self-operate import and export business.
2. Personnel Management
1. Company personnel
The company currently has 75 employees, 22 of whom have bachelor's degree or above, accounting for 29.3% of the total number of employees, including 10 professional and technical personnel, accounting for 13.3% of the total number of employees.
2. Institutional setting
Departmental responsibility system under the leadership of the chairman of the company. There are production technology department, quality management department, purchasing department, sales department, finance department and other departments to ensure the normal operation and development of the company.
The production technology department consists of equipment engineering department, solid preparation workshop and soft capsule workshop. The Quality Management Department has workshop on-site quality supervision and a central laboratory, and is equipped with corresponding professional and technical personnel and management personnel with production and organization capabilities.
3. Staff training
According to the requirements of "Food Safety Law" and "Health Food Good Manufacturing Practices", a training plan is developed, and employee files are established, and all employees will be trained according to the training plan by face-to-face instruction and examinations. Company leaders and quality management personnel will conduct training. Face-to-face instruction, and annual traffic safety knowledge and fire safety knowledge training are also arranged.
Three, health management
The company has formulated various sanitation management systems in accordance with the requirements of "Good Manufacturing Practices for Health Foods". The sanitation in the plant area is responsible for the management of districts, and the management procedures for cleaning and disinfection have been formulated respectively. It is equipped with appropriate sanitation and sanitation facilities. Each position in the production workshop According to process requirements, clean and disinfect in accordance with the clean area sanitation and cleaning procedures, and have records. In the clean area, use cleaning tools that are easy to clean without falling off, and the cleaning tools are concentrated and stored in the inner sanitary ware room. The production area is strictly managed, and no makeup or accessories are allowed to enter the production area, and no food is allowed into the production area. On-site quality supervisors are equipped to supervise and inspect at any time.
Four, raw material management
The company has formulated a series of standard management procedures for material procurement, acceptance, inspection, storage, distribution, and use in accordance with the requirements of "Health Food Good Manufacturing Practices". All raw materials used are purchased from legally qualified companies, and suppliers are requested when purchasing. The relevant qualification certificates of the enterprise and the establishment of supplier accounts.
Investigate and evaluate the suppliers of main raw materials and packaging materials, determine the company's designated suppliers to ensure the stability of raw materials, and strictly control the quality of incoming raw materials for comparison and inspection. The company has warehouses, raw materials warehouses, and packaging materials warehouses. , Label warehouse, shade warehouse, room temperature warehouse, etc., all raw materials are stored as required. The warehouse is equipped with facilities such as rat blocking boards and anti-rat lamps, and the warehouse has normal lighting and ventilation.
The picker picks up the required raw and auxiliary materials in accordance with the production instructions, records and signs. The packaging label instructions are made in strict accordance with the content and text of the health food approval certificate issued by the State Food and Drug Administration, and printed after being reviewed by the Quality Management Department. The labels are stored in a dedicated label library for strict management.
Five, storage and transportation
According to the "Health Food Good Production Management Practice", the principle of first production and first sale is implemented. The finished product warehouse has complete facilities and reasonable partitions. It is stored in strict accordance with the storage requirements specified in the health food approval certificate and has a finished product flow register.
6. Design and facilities
1. Factory layout
The site of our company is located next to the 310 National Road in Gulou Industrial Park , Kaifeng City , far away from pollution, the surrounding environment is suitable, and the sanitary condition is good. The roads around the factory area are unobstructed, the transportation is convenient, and the overall layout of the factory area is reasonable. The production area, administrative area, and living area are strictly separated without hindering each other. , No pollution to health food production, smooth and unobstructed roads in the factory area, no dust, no water accumulation, lawn cover in the open area of the factory area, no weeds, garbage and mosquito breeding grounds, and the factory environment conforms to the principles of "Good Manufacturing Practice for Health Food" Hygiene requirements under.
2. Production area
The production workshop is designed in accordance with the requirements of "Good Manufacturing Practices for Health Foods". The clean area and the general area are partitioned by color steel plates, and the roommate buffer facilities between the clean area and the non-clean area are strictly separated from the flow of people and the logistics are strictly followed. The procedure enters the clean area.
The clean production area covers a total of 2500 square meters, and the layout of clean workshops is reasonable, all built according to the level of 100,000 clean workshops. The general area is compatible with the current production scale. The product packaging, purified water preparation, central air conditioning system, air compression system, etc. are all set in the general production area, and the layout is more reasonable, which can avoid the mutual interference of production operations in the factory. The safety facilities in the plant are complete, with emergency lighting facilities , safety doors, and safety escape indicators, which meet the actual needs of the plant.
3. Production equipment and facilities
The structure, materials, and performance of the production equipment meet the requirements of "Good Manufacturing Practices for Health Foods" and can meet the needs of the production process. The equipment, containers, and utensils that directly contact the product are made of stainless steel, and the surface is smooth and clean, easy to clean and disinfect, Corrosion resistant and will not change with the product. The production equipment and facilities have obvious status marks. The pipes connected to the production equipment have arrows of different colors to indicate the flow direction. The installation of the equipment and pipes meets the requirements.
The company has a dedicated purified water preparation room, which can fully meet production needs. Purified water uses drinking water as the source of preparation, filtered, activated carbon adsorption, and secondary reverse osmosis. Its pipelines and storage tanks are made of stainless steel. The purified water is sampled and inspected by the central laboratory and sent to a third-party inspection agency for inspection every year.
4. Central laboratory
The company has a central laboratory set up separately from the production area. The central laboratory has a precision instrument room (1) (2), ordinary instrument room, balance room, physical and chemical room, heating room, glass instrument room, microorganism preparation room, and microorganisms. Testing room, sample retention observation room, etc., in which the microbial testing room is a 10,000-level purification area, and the ultra-clean workbench is a local 100-level purification area. The air conditioner is installed to adjust the temperature of the inspection room to ensure that the inspection environment meets the requirements.
5. Inspection equipment
The company's inspection instruments, measuring tools, electronic balances, ultraviolet spectrophotometers, high performance liquid chromatographs, gas chromatographs, portable autoclaves, mold incubators, bacterial incubators, etc. have all passed the quality and technical supervision department with qualifications. Perform appraisal and issue appraisal certificates. The inspection equipment is compatible with production and can meet the requirements of product factory inspection.
Seven, production management
Our company obtained the health food production license for the first time in 2011, and strictly followed the requirements of "Health Food Good Manufacturing Practice" for production and quality management.
All products of the company are formulated in accordance with the formula and production process of the health food approval certificate issued by the State Food and Drug Administration to formulate production process regulations and post operation procedures. The production process includes product formula, production process, operation process, key control points, etc. , Without any changes.
The production workshop is strictly in accordance with the production process and must not be changed. Each batch of production is supervised by the on-site quality inspector of the workshop to clear the site batch by batch. The on-site quality inspector of the workshop will inspect each batch and issue a clearance certificate after passing it. The certificate should be pasted into the batch production record.
The company regularly organizes self-examinations, and finds the responsibility of the people to rectify within a limited time. Through continuous efforts, the quality awareness of the company's employees has been significantly improved, the entire production process is strictly regulated, and the product quality is effectively guaranteed.
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