Medical network on January 5 - to guide medical device manufacturing enterprise according to the product registration or registration of technical requirements for quality management, strengthen the quality control in the process of purchasing, production, inspection, strict medical equipment product releasing, enhance the level of product quality assurance, according to the medical devices supervision and administration of production methods, state food and drug supervision and administration of administration makes no. 7) and "medical equipment production and the quality control standard" (the state food and drug administration bureau announcement no. 64, 2014), the state food and drug supervision and management of administration organization developed the medical device manufacturing enterprise quality control and product releasing guide, are hereby issued.
Please take note.
Attachment: medical device manufacturing enterprise quality control and product releasing guidelines
The food and drug supervision bureau
On December 30, 2016
The attachment
Medical device manufacturing enterprise quality control and product releasing guidelines
Medical device manufacturing enterprise (hereinafter referred to as enterprises) shall, in accordance with the "medical equipment production and the quality control standard" (the state food and drug administration bureau announcement no. 64, 2014) and the appendix, strengthen the product realization process, especially the procurement and production process quality control and finished product release and management, to ensure the release of medical apparatus and instruments for filing, the products conform to the compulsory standards as well as a certified or technical requirements.
A, scope of application
Referred to in this guide quality control, including the main raw materials, spare parts, related to the product at the beginning of outsourcing, intermediates, finished products, packaging materials, labels, and other relevant verification/confirmation/monitoring/measurement/inspection/testing activities and quality management, including related to the production process, especially related to the key working procedure in the production process and special process validation/confirm/monitoring/measurement/inspection/testing activities and quality management.
This guide refers to the finished product release, not including procurement items and intermediate release procedure. Enterprises can refer to the principles of medical apparatus and instruments product releasing, make procurement items and intermediate release program on its own.
This guide does not include the environment related to production, testing, facilities, equipment and related quality control and management of the process, such as environmental monitoring, manufacturing, testing a clean area of auxiliary technology aided process of water, gas quality management requirements. Such as the quality control and management activities and purchasing items, intermediates, or directly related to the product requirements, then this guide as a purchasing items, intermediates, or part of the finished product requirements.
Second, the quality control and finished product release
Enterprise shall be based on regulatory requirements, risk management demands, product technology, product features, the scale of production, process characteristics, such as the actual quality management ability, determine the product realization process, especially the purchasing and production process validation/qualification/monitoring/measurement/inspection/testing procedures and requirements.
Enterprises shall for purchasing items, intermediates and finished products and related process, after completion of the medical device design and development, especially in the design after the conversion, output incoming inspection procedure, process, inspection procedures and inspection regulations system such as comprehensive quality control documents, to guide the product realization process, especially the procurement and production process quality control and product releasing work, make sure you use conform to the requirements of the procurement items, flow conforms to the requirements of the intermediates, release of finished products.
(a) procurement control, and receiving inspection
Enterprises shall establish and implement the procurement control procedures. Supplier management shall refer to the medical device manufacturing enterprise supplier audit guide (state administration of food and drug supervision and administration of notice in 2015 no. 1) the relevant requirements, to ensure that the requirements of the procurement items conform to, and not under the related provisions of the laws and regulations and the requirements of the relevant compulsory standards.
Enterprise shall, according to purchasing items influence degree on the quality of products, determine to purchase items, especially for a greater influence on the final quality of the main raw materials, spare parts, components, such as the implementation of conventional control verification/confirmation/monitoring/testing/inspection/testing procedures and requirements, to make sure they conform to specified requirements. Received and rejected and related disposal measures should be recorded.
Enterprises shall establish and implement incoming inspection procedures. Incoming goods inspection procedures at least shall specify the name of the procurement items, specifications, verify/confirm/monitoring/measurement/inspection/test items and method, suitable equipment and instruments, sampling procedure, sample plan, acceptance criteria, the reference standard/reference measurement procedures and records, etc. Sampling plan should be statistically basis, shall analyze the confidence level of statistical inference, and ensure the sampling of the sample is representative.
(2) of the process control and process inspection
Enterprise shall, according to the degree of impact on the quality of the finished product production process, determine the intermediates, the production process to implement regular control verification/confirmation/monitoring/testing/inspection/testing procedures and requirements, to ensure that the requirements of the production process control, production process. Received and rejected and related disposal measures should be recorded.
Enterprises shall establish and implement process inspection procedures. Process inspection procedures at least shall specify the name, specification model, validation of the intermediates/confirm/monitoring/measurement/inspection/test items and method, suitable equipment and instruments, sampling procedure, sampling plan and acceptance criteria, the reference standard/reference measurement procedures and records, etc. Sampling plan should be statistically basis, shall analyze the confidence level of statistical inference, and ensure the sampling of the sample is representative.
Enterprises shall validate of key working procedure, to confirm the special process. Validation/qualification records shall at least include validation/qualification plan, validation/qualification program and method, operating personnel, the results of evaluation and validation/reconfirm, etc. Used in the process of production of computer software to have an impact on product quality, should also be instituted.
Enterprise shall, according to the key process and special process validation/qualification or validation/reconfirm as a result, the key working procedure, special process to implement the necessary test, the monitoring and measurement of process parameters. Process parameters of the monitoring and measurement requirements can be included in the process of work instruction document, can also be included in the process of inspection procedures.
(3) the finished products inspection and finished product release
Enterprise shall, according to the compulsory standards as well as a certified or registered product technology demands, product delivery, such as enterprise internal control standards for finished goods inspection procedures. Finished goods inspection procedures shall determine the finished product need to implement regular control verification/confirmation/monitoring/testing/inspection/testing procedures and requirements, to ensure that each batch of finished product is conformity with the acceptance criteria. Received and rejected and related disposal measures should be recorded.
Finished goods inspection procedures shall at least clear product name, specification model, validation/verification/monitoring/measurement/inspection/test items and methods, suitable equipment and instruments, sampling procedure, sampling plan and acceptance criteria, the reference standard/reference measurement procedures and records, etc. Sampling plan should be statistically basis, shall analyze the confidence level of statistical inference, and ensure the sampling of the sample is representative.
The content of the finished product inspection procedures in principle should cover has set up a register or technical requirements of the products in need regular inspection items and inspection method of control. Can't cover, should be in the finished product inspection procedures. When necessary, shall be given after confirmation of alternative solutions.
Enterprises shall establish and maintain procedures and implementation of product release, clear product releasing conditions, release approval requirements. Finished product at least before release shall meet the following conditions: complete all the rules of process flow; In batch production records complete is complete; All the rules of replenish onr's stock, process, finished product inspection and verification is complete, the quality control of a complete record results conform to the requirements of the rules, inspection/test/verification/confirmation and audit, authorized personnel records have been issued in accordance with provisions; Product realization process, especially in the process of purchasing, production and other unqualified, rework, repair, downgraded, emergency release such a special case is processed by the regulation; Product manuals, labels and its version conform to specified requirements; Be authorized to release staff has issued by single product release by the regulation, approve the finished product release.
(4) other relevant requirements
If supplier production and quality management ability fluctuations, enterprise production and quality management capabilities could cause obvious to purchase items, intermediates and finished products quality, used to monitor the fluctuation of verification/confirmation/monitoring/measurement/inspection/testing project in principle shall be separately into the incoming goods inspection, process inspection and finished goods inspection of conventional control project.
Need regular control of incoming goods inspection, process inspection and finished goods inspection items, in principle, shall not entrust the inspection. For inspection/test conditions and equipment demand is higher, is really necessary to entrust the inspection project, can entrust a qualified inspection institution for inspection.
Enterprise determines purchasing items, intermediates and finished products quality control and testing methods of performance index, shall give priority to with the national standards, industry standards, especially mandatory national standards, industry standards of the related content; The second should consider adopting international standard related content. If the national standards, industry standards and international standard does not apply to, can use industry practice or to build enterprise internal control standards. When necessary, the enterprise shall establish internal control standard test methods to carry out verification and validation.
If the same kind of quality control performance index has a variety of test methods, the enterprise shall, according to test purposes determine the appropriate test methods, and be clear in the corresponding inspection procedures. When necessary, the enterprise shall, in the internal control standards establish corresponding relationship with external standard room.
Testing involved in standard material, shall give priority to use national standard substances.
Enterprise principle given shall not adopt any of the following standards: greatly influenced the quality of the finished product of main raw materials, spare parts, components, such as purchasing items only implements the appearance inspection, check the supplier finished goods inspection report, not for the purchase items key quality control performance index for inspection/testing/verification/confirm the release; Intermediates and finished products of the most important quality of key working procedure control performance index in inspection/testing/verification/confirm the circulation; No process parameters for the specific process after the confirmation or not implement effective monitoring and measurement for special process or flow of intermediates and finished products; Important to the finished product quality control performance index with incoming goods inspection, process inspection data transfer is only release; Finished goods inspection cannot be covered by the product technical requirements for registration or registration shall be conducted in regular inspection items and inspection method of control and can not give a reasonable reason.
If after a risk assessment, is really necessary to release the above mentioned methods parts procurement items, intermediates and finished products, the enterprise should conduct related procurement items, intermediates and finished products and related process to carry out strict supplier lead management, and in a certain period to carry out the appropriate frequency of inspection/testing/verification/validation activities. If the accumulation of data to prove that the product realization process, especially in the process of purchasing and production quality control activities are appropriate, sufficient and effective, to implement quality control scheme of the simplified.
Enterprises shall establish and implement data analysis program. Enterprise shall collect and quality control of product quality control, product releasing related operation data, using appropriate statistical techniques, regular trend analysis was carried out on the related data, the formation of periodic reports product quality control, deviation may be produced, and treatment by the regulation off or overrun events, take timely corrective and preventive actions when necessary. Enterprises shall regularly to control the product quality control, product releasing suitability, adequacy and effectiveness of the review, and implement the necessary follow-up.
Three, terminology,
In this tutorial, the definitions of the following terms are:
Validation: through the provision of objective evidence of specified requirements have been satisfied. (" medical equipment production and the quality control standard ", the state food and drug supervision and administration bureau announcement no. 64, 2014)
Confirmed: through the provision of objective evidence for a specific intended use or application demands have been met. (" medical equipment production and the quality control standard ", the state food and drug supervision and administration bureau announcement no. 64, 2014)
The key working procedure: refers to the process of product quality, is crucial. (" medical equipment production and the quality control standard ", the state food and drug supervision and administration bureau announcement no. 64, 2014)
Special process: refers to through the inspection and testing is difficult to accurately assess the quality of the process. (" medical equipment production and the quality control standard ", the state food and drug supervision and administration bureau announcement no. 64, 2014)
Inspection: by observation and judgment, appropriate combination of measurement, test or measure of conformity assessment. (GB/T 19000-19000 "quality management system and the term")
Test: according to the program to determine one or more features. (GB/T 19000-19000 "quality management system and the term")
In need of special note other terms:
About the definition of degree of confidence, see the GB/T 3358.1 2009 words and symbols of statistics part 1: general statistical terms and terminology used in probability and degree of confidence, confidence interval in the definition of related terms. Confidence reflected in the same under the condition of a large number of repeat random sampling, the confidence interval contains parameters in proportion to the true value.
About the meaning of the monitoring and measurement, see and YY/T 0287-2003 "medical device quality management system for regulatory requirements, related statements and provisions on the monitoring and measurement. |
