Special series of quality risk management - Analysis of relevant normative documents and guidelines

The normative documents and guidelines related to quality risk management include: ISO series guidelines, relevant guidelines of pharmaceutical industry (this article mainly refers to ICH guidelines) and laws and regulations with enforcement effect ISO 9001:2015 / the standard of the people's Republic of China GB / T 19001-2016 quality management system requires 0.1 general rules Risk based thinking enables the organization to determine various factors that may cause its process and quality management system to deviate from the planning results, take preventive control, reduce adverse effects to a large extent, and make use of the opportunities to a large extent The guide emphasizes that opportunities and risks coexist in the management of an organization Based on risk-based thinking, when planning a quality management system, the organization should fully understand the management objectives and expectations of the organization, identify various factors that may lead to deviation of the quality management system in the organization and its environment, evaluate and determine adverse factors, formulate relevant countermeasures, and prevent or reduce adverse factors Impact caused by factors; evaluate and determine favorable factors to increase the impact of favorable factors; countermeasures shall be adapted to the potential impact of risks and opportunities on the conformity of products and services These contents are also applicable to the quality risk management of the pharmaceutical industry Risk-based thinking is the basis of the effectiveness of quality management system Enterprises need to actively identify and control risks; reasonably allocate and use enterprise resources, scientifically control risks, so as to avoid risks, seize opportunities, promote the realization of quality system objectives, and promote continuous improvement According to the requirements of relevant regulations on quality risk management in China, Article 13 of GMP quality risk management is a systematic process to evaluate, control, communicate and audit quality risk in the whole product life cycle by means of looking forward or reviewing From the perspective of implementation, this paper points out the ways of quality risk management, including prevention in advance, that is, forward-looking risk assessment, risk identification in advance, establishment of response measures, so as to reduce the adverse effects of risks; for quality risk events that have occurred, factor analysis based on facts and data can be adopted to identify the adverse effects of risks, and corrective and preventive measures can be taken to Ensure product quality Article 25 of the new drug administration law, the drug regulatory department shall organize pharmaceutical, medical and other technical personnel to review the application for registration of drugs, to review the safety, effectiveness and quality controllability of drugs, as well as the applicant's ability in quality management, risk prevention and control, responsibility compensation, etc.; if the requirements are met, the drug registration certificate shall be issued The new "Drug Administration Law" emphasizes that the holders of marketing license should have the ability of quality management, risk prevention and control, liability compensation, etc., and should establish the whole life cycle quality risk management from the aspects of drug development, production, operation, use, etc The drug listing license holder shall evaluate the quality assurance ability and risk management ability of the entrusted drug production enterprise, the entrusted drug trading enterprise, the entrusted drug storage and transportation enterprise, sign an entrustment agreement with them, stipulate the drug quality responsibility and relevant contents, and supervise the entrusted party The holder of the drug listing license shall establish an annual report system; formulate a post marketing risk management plan; take corresponding risk management measures for the drugs subject to conditional approval, and complete relevant research within the prescribed time limit according to the requirements; carry out post marketing adverse reaction monitoring; establish a drug traceability system, etc The establishment of the above-mentioned system promotes the drug marketing license holders to actively and systematically identify risks, establish risk prevention and control measures, ensure the full implementation of quality responsibility, and provide guarantee for product quality The definition of quality risk in ICH Q9 quality risk management is as follows: risk refers to the combination of the possibility and severity of hazard The guideline puts forward two basic principles of quality risk management: first, the evaluation of quality risk should be based on scientific knowledge and related to the end purpose of protecting patients; second, the strength, formality and documentation of quality risk management process should be adapted to the risk level ICH Q9, as an applicable guideline for quality risk management of pharmaceutical enterprises, not only gives the basic ideas and methods of quality risk management, but also gives the corresponding quality risk assessment tools The application of this guideline is helpful for the effective development of quality risk work of enterprises ICH Q10 "drug quality system" 1.6.2 quality risk management, quality risk management is an indispensable part of an effective drug quality system, which can provide an active method for the identification, scientific assessment and control of potential quality risks; promote the continuous improvement of process performance and product quality throughout the product life cycle ICH Q9 provides examples of principles and methods of quality risk management, which can be applied to different aspects of drug quality ICH Q10 "drug quality system" is the application guide of the quality management system of pharmaceutical enterprises, which emphasizes the importance of quality risk management in the quality management system; it emphasizes the active risk identification and risk control, and advocates the comprehensive application of quality risk management methods in the whole life cycle of drugs to promote the continuous improvement of product quality Generally speaking, the normative documents and guidelines related to quality risk management give us clear and clear guidance We need to learn and apply relevant requirements, and apply the thinking mode of quality risk management to our quality management activities effectively and systematically References: [1] Drug Administration Law of the people's Republic of China Revised at the second session of the 12th meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019 [2] standard quality management system requirements of the people's Republic of China GB / T 19001-2016 / ISO 9001:2015 [3] drug production quality management code (revised in 2010) (Order No 79 of the Ministry of Health) [4] ICH Q9 Quality risk management [5] ICH Q10 drug quality system