产品质量回顾期间， 产品数据应被进行有选择性的评估且趋势分析应被执行，

During product quality review, product data should be selectively evaluated and trend analysis should be performed, especially for batches with deviations or changes. The deviated CAPA and the effect of the change should be confirmed and whether there are other new risks, so as to provide a reasonable evaluation for the review conclusion such as the product process performance is good or the control of revalidation or change of sampling is required. <br>Change control <br>risk management facilitates the continuous improvement of the process in the product life cycle, and is implemented through change control; <br>the impact of changes in facilities, equipment, materials, production processes, and technology transfer on product quality and safety is evaluated; <br>implementation changes are required Appropriate measures to be taken are determined, such as additional testing, reconfirmation, revalidation, or filing or supplementary application after consulting the drug regulatory authority. <br><br>Quality risk management in product development <br><br>Risk management is conducive to deepening the understanding of material properties, process research and process parameters related to product performance. <br><br>The key quality attributes of materials should be evaluated to facilitate the development of appropriate internal control standards. <br>Appropriate specifications, key process parameters, and production process control should be determined by using the information obtained during drug development and referring to the clinical significance of the quality characteristics and the ability of process control quality. <br><br>Quality risk management of <br><br>plant facilities, equipment and public systems The design of plant facilities, equipment and public systems should be based on the demand for product technology and the control of product quality risks, such as the flow of people, logistics, and the layout of the process, facilities, and equipment. , The material of the container, appropriate public systems (including purified water systems, water injection systems, ventilation and air-conditioning systems, compressed air systems, cooling systems, etc.), closed production systems, rat-proof design and facilities, fire safety facilities, etc., to prevent Confusion, reduce the possibility of contamination and cross-contamination. <br><br>How to protect personnel, environment, and products should be considered to reduce related hazards, such as the use of facilities and tools (such as single product or multi-product use), cleaning requirements (cleaning each batch or cleaning after continuous production), and whether the environment is controlled Meet product requirements, etc.

During a product quality review, product data should be selectively evaluated and trend analysis performed, especially in batches with deviations or changes. The varied CAPA and the effect of the change should be confirmed and whether there are other new risks, providing a reasonable assessment of the review conclusions such as good product process performance or the need for re-validation or alteration of sampling.<br>Change control.<br>Risk management facilitates continuous process improvement throughout the product life cycle and is implemented through change control;<br>The impact of changes in facilities, equipment, materials, production processes and technology transfer on product quality and safety is assessed;<br>Appropriate measures to be taken to implement the changes are identified, such as additional testing, re-confirmation, re-verification, or filing or supplementary applications after consulting the Drug Enforcement Administration.<br><br>Quality risk management in product development.<br><br>Risk management is conducive to deepening the understanding of material properties, process research and process parameters and other knowledge related to product performance.<br><br>The key quality attributes of the material should be evaluated to help develop appropriate internal control standards.<br>Appropriate specifications, key process parameters and production process control should be determined by using the information gained in drug development and by reference to the clinical significance of the quality characteristics and the ability of the process to control the quality.<br><br>Quality risk management of plant facilities, equipment and common systems.<br><br>Plant facilities, equipment and utility systems should be designed on the basis of the demand for product processes and product quality risk control, such as flow of people, logistics, process-based layout, facilities, equipment, container materials, appropriate public systems (including purified water systems, injection water systems, ventilation and air conditioning systems, compressed air systems, cooling systems, etc.), closed production systems, rat-proof design and facilities, fire safety facilities, etc., to prevent confusion, reduce pollution and cross-contamination.<br><br>How to protect people, the environment, and products should be considered to reduce related hazards, such as the use of facility tools (e.g., for single or multi-product use), cleaning requirements (cleaning per batch or continuous post-production cleaning), and whether environmental controls meet product requirements.

During product quality review, product data should be selectively evaluated and trend analysis should be performed, especially for batches with deviations or changes. The deviation CAPA and the effect of the change should be confirmed and whether there are other new risks, so as to provide a reasonable evaluation for the review conclusion, such as the good process performance of the product or the need for re verification or sampling change.<br>Change control<br>Risk management facilitates the process continuous improvement in the product life cycle and is implemented through change control;<br>The impact of changes in facilities, equipment, materials, production process and technology transfer on product quality and safety is evaluated;<br>Appropriate measures to be taken to implement the change have been determined, such as additional testing, reconfirmation, revalidation or filing or supplementary application after consulting the drug administration.<br>Quality risk management in product development<br>Risk management is helpful to deepen the understanding of material properties, process research and process parameters related to product performance.<br>The key quality attributes of materials should be evaluated to facilitate the development of appropriate internal control standards.<br>The appropriate specifications, key process parameters and production process control should be determined by using the information obtained in drug development and referring to the clinical significance of quality characteristics and the ability of process control quality.<br>Quality risk management of plant facilities, equipment and utility systems<br>The design of plant facilities, equipment and utility system should be based on the requirements of product process and the control of product quality risk, such as flow of people, logistics, plane layout according to process flow, materials of facilities, equipment, containers, appropriate public systems (including purified water system, injection water system, ventilation and air conditioning system, compressed air system, cooling system, etc.) and closed production System, rodent proof design and facilities, fire safety facilities, etc., so as to prevent confusion and reduce the possibility of pollution and cross contamination.<br>How to protect personnel, environment and products should be considered to reduce related hazards, such as the use of facilities and tools (such as single product or multiple products), cleaning requirements (cleaning after each batch of cleaning or continuous production), and whether the environmental control meets the product requirements.<br>