风险评估应被 对产品生产中相关的设备设施、物料、生产环境、生产程序、关

Risk assessment should be carried out on all aspects that may affect product quality, such as related equipment and facilities, materials, production environment, production procedures, key process parameters, etc., in order to find the key control points with the greatest product risk and formulate measures Avoid or reduce this risk. <br>The key process parameters and the frequency and content of sampling and monitoring in the intermediate process should be determined. <br>A reasonable production plan should be formulated, and resources must be used rationally to avoid or reduce the risk of pollution and cross-contamination. <br>Quality risk management of laboratory control and stability research The quality risk <br>should be controlled by the laboratory in terms of methods, reagents and test solutions, instruments and equipment, measuring instruments, personnel operations, sampling, sample management, etc., to ensure the accuracy and reliability of the test results and reduce the experiment The error of the result reduces the over-standard result caused by the laboratory error. <br><br>The retest period and validity period of the product are confirmed through stability studies to ensure the quality of the product life cycle. <br>Quality risk management <br>in packaging design The selection and design of inner packaging should ensure that the product has a good airtight state and reduce the impact of the environment and foreign substances on product quality. <br>The design of the outer packaging should be able to fully protect the inner packaging from transportation, environment, etc. <br>Label control should ensure compliance with regulatory requirements, no confusion, and provide users with correct guidance. <br>Quality risk management runs through the process of product design, research and development, technology transfer, production, regular evaluation, and change. It takes customer requirements as the starting point, continuous improvement, and continuous customer satisfaction. <br>Product quality retrospective analysis is carried out on all listed products produced by the company every year to confirm the stability and reliability of the process, as well as the applicability of the current quality standards for raw materials and finished products, to discover bad trends in time, and to confirm the direction of product and process improvement.

Risk assessment should be carried out on all aspects of the equipment facilities, materials, production environment, production procedures, key process parameters, etc. that may affect product quality in order to identify the key points of control where product risk is greatest and to develop measures to avoid or reduce that risk.<br>Key process parameters and the frequency and content of intermediate process sampling and monitoring should be determined.<br>Reasonable production plans should be developed and resources used rationally to avoid or reduce the risk of contamination and cross-contamination.<br>Quality risk management for laboratory control and stability research.<br>Quality risk should be controlled by the laboratory from the method, reagent reagent, instrument equipment, measuring device, personnel operation, sampling, sample management and so on, to ensure the accuracy and reliability of the test results, reduce the error of the experimental results, reduce the excess results caused by laboratory errors.<br><br>The re-inspection period and validity period of the product are confirmed by the stability study to ensure the quality of the product life cycle.<br>Quality risk management in packaging design.<br>The choice design of inner packaging should ensure that the product has a good state of closure, reduce the impact of environmental and foreign substances on product quality.<br>The design of the outer packaging should be able to fully protect the inner packaging from transportation, environment and other effects.<br>Label control should ensure compliance with regulatory requirements, not confusion, to provide users with the right guidance.<br>Quality risk management runs through product design, research and development, technology transfer, production, regular evaluation, change process, customer requirements as a starting point, continuous improvement, and constantly make customer satisfaction.<br>Product quality review and analysis of all the company's production of listed products by variety each year, to confirm the stability and reliability of the process, as well as raw materials, finished products, the applicability of current quality standards, timely detection of adverse trends, confirm the direction of product and process improvement.

Risk assessment should be carried out on all aspects of equipment and facilities, materials, production environment, production procedures, key process parameters, etc. that may affect the product quality, so as to find out the key control points with the greatest product risk and formulate measures to avoid or reduce the risk.<br>The key process parameters and the frequency and content of sampling and monitoring in the intermediate process should be determined.<br>Reasonable production plan should be made and resources should be used reasonably to avoid or reduce the risk of pollution and cross contamination.<br>Quality risk management of laboratory control and stability research<br>The quality risk should be controlled by the laboratory from the aspects of method, reagent test solution, instrument and equipment, measuring instrument, personnel operation, sampling and sample management, so as to ensure the accuracy and reliability of the test results, reduce the error of the test results, and reduce the excessive results caused by laboratory errors.<br>The re inspection period and validity period of the product are confirmed by stability study to ensure the quality of the product life cycle.<br>Quality risk management in packaging design<br>The selection and design of inner packaging should ensure that the product has good airtight state and reduce the impact of environment and foreign substances on product quality.<br>The design of the outer package should be able to fully protect the inner package from the influence of transportation and environment.<br>The control of labels should ensure that they meet the requirements of laws and regulations without confusion and provide correct guidance to users.<br>Quality risk management runs through the process of product design, R & D, technology transfer, production, regular evaluation and change. It takes customer requirements as the starting point, continuously improves and constantly satisfies customers.<br>Product quality review and analysis shall be carried out for all listed products produced by the company every year according to their varieties, so as to confirm that the process is stable and reliable, as well as the applicability of the current quality standards for raw materials and finished products, timely detect adverse trends, and confirm the direction of product and process improvement.<br>