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 documents, and approved quality management department decides whether to approve the product to market prerequisites. 3, verify eligibility criteria must be established in accordance with the requirements of 高标准 regulations and users should quantify 高标准 standard workshop, it should be quantitative criteria to evaluate the results of verification. 4. Verify that the program should include verification of objectives, methods and quality standards 高标准 standard 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. The new certification: According to Minister of Health, People's Republic of China, signed Decree 79 of 2011, the "Good Manufacturing Practice (revised 2010)" (hereinafter referred to as the new 高标准) was October 19, 2010 by the Ministry of Health, Ministry of Finance Meeting 高标准 approved the purpose of implementing effective from March 1, 2011. Chinese New 高标准 compared with version 98 considerable progress from the management and technical requirements. Especially for the production of sterile preparations and APIs made high demands, the new EU 高标准 高标准 basis, taking into account the domestic gap in version WHO2003 bottom line. New 高标准 certification has two time node: pharmaceutical manufacturers of blood products, vaccines and injections of sterile drug products, should reach new drugs 高标准 requirements in December 31, 2013; the production of other types of drugs should be in December 2015 May the 31st reach new drugs 高标准 requirements. Does not meet the new 高标准 requirements for pharmaceutical companies (workshop), after the predetermined period not to continue production of 高标准 verification criteria |. Maoming 高标准 | Enterprise Road (View) provided by enterprises in Huizhou City Road Enterprise Management Services Limited. Road Zhiyuan, temper forward. Huizhou City, the rate of the Road Enterprise Management Services Ltd. (isoew.com) aims to become and you win symbiosis, strategic partners to move forward, more determined to become the other's most influential business, and you leap together to success!