New 高标准 reflect what new ideas? In the new version of 高标准, the timely introduction of a new concept of quality risk management 高标准 development process, such as explicitly requires enterprises to establish a quality management system, quality management to introduce risk management, emphasis on the implementation of 高标准 in to the scientific and risk-based. Pharmaceutical production process contamination, cross-contamination, and other risks confusion and error, not simply to identify problems in accordance with the quality standards through testing, it must be controlled during production. Therefore, the introduction of new 高标准 concept of risk management, and a corresponding increase in the number of the new system, such as: supplier audit and approval, change control, deviation management, excessive (OOS) investigations, corrective and preventive actions (CAPA), continued Stability programs, product quality review analysis, respectively, from raw materials procurement, production process changes, the operation of deviation handling, investigation and correct problems found, aspects of drug quality continued monitoring after the listing may appear on all aspects of risk management and control, encourage manufacturers to set up the whole chain, the corresponding system of professional 高标准 training, to discover the impact of unsafe drug quality, quality initiative to prevent the occurrence of accidents, in order to ensure maximum quality of the finished product and marketed drugs. Followed by the introduction of a new concept of quality management system. New 高标准 requirements for pharmaceutical companies should establish a clear comprehensive, systematic and strict quality management system, and must be equipped with adequate resources, including human resources and management system to ensure the effective operation of the quality system. Before in the consciousness of many people, quality management and implementation of 高标准 is a matter of quality management and quality management. The new version of 高标准 quality reflects the full participation of philosophy, emphasizing the legal, business executives, including the quality responsibility quality manager, quality attorney and other senior management staff, makes pharmaceutical production enterprise quality management and more comprehensive. This is the "business is primarily responsible for drug quality," the further implementation reflects the modern enterprise management concepts Systematic Management. Principle requires verification criteria 高标准 certification enterprises validation, process validation has the following specific requirements: 1, the key process should be reviewed prior to verification or validation; 2, before the new process of order or a new preparation method, you should verify their routine Applicability of production; the use of certain specified materials and equipment to determine the production process should be able to consistently and production to meet the quality requirements of the product. 3, the production process of major changes must be verified; follow the principle requires authentication, companies generally can be the following rules as the standard of the enterprise. 1. Verify that the master plan must be developed, according to plan the implementation of verification; 2, a complete verification file 高标准, and approved quality management department decides whether to approve the product to market prerequisites. 3, must be established to verify eligibility criteria in accordance with the requirements of the relevant regulations and what the user is 高标准, standards should be quantified, it should be quantitative criteria to evaluate the results of verification. 4. Verify that the program should include verification of objectives, methods and eligibility criteria, verification programs should be approved by the quality control department before implementation. 5, systems, equipment, computers, technology, public works and instrumentation should be confirmed according to the installation acknowledgment scheme approved. 6, the need for systems, equipment, computers, technology, public works and instrumentation according to the approved program run run confirm confirmation should be run to confirm the time required to run, run to confirm the results of the quality control department shall review and approval. 7, the need for systems, equipment, computers, technology, public works and instrumentation for confirmation according to the approved performance verification program. Performance verification should be carried out under ambient conditions conventionally produced. 8, except in special cases, the quality management department has the right to make exceptions, the products are validated batch of not less than 3, the production of the product must meet the eligibility criteria specified in the verification program, in addition, the product used for authentication systems, equipment, computer , technology, public works and instrumentation must have the appropriate verification documents. 高标准 training Which strong enterprises of the road (certified), Zhaoqing, Huizhou City, the rate offered by 高标准 Road Enterprise Management Services Limited. Huizhou City, the rate of the Road Enterprise Management Services Ltd. (isoew.com) Guangdong Huizhou, other leaders, over the years, the company is implementing the scientific management, innovation and development, the principle of honesty and trustworthiness, and satisfy customer needs. 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