What does the IVD quality system include?
The in vitro diagnostic quality system provides guidance and specifications for the selection, procurement and use of in vitro diagnostic reagents. In vitro diagnostic quality system includes quality management system, process control, equipment calibration, personnel training and quality assessment. These requirements and processes can help medical institutions or laboratories select appropriate in vitro diagnostic reagents, ensure that the quality of the reagents meets the requirements, and strictly manage and control the procurement and use of reagents to reduce uncertainty and the risk of errors. The system usually consists of the following aspects:
1. Quality management system:
In vitro diagnostic reagent manufacturers should establish a complete quality management system and follow relevant national and international quality management standards, such as ISO 13485 medical device quality management system standard. The quality management system includes quality policies, quality manuals, procedure documents, quality objectives and indicators, etc., and is monitored and improved through internal audits, management reviews and other means.
2. Quality control:
In vitro diagnostic reagent manufacturers need to establish a scientific and effective quality control system to ensure product consistency and reliability. Quality control includes raw material selection and review, production process control, product inspection and verification, correct laboratory use and calibration, etc. In addition, stable reference materials and positive and negative controls need to be established for product quality control and performance verification.
1. Raw material control: The raw materials of in vitro diagnostic reagents have an important impact on product performance and stability. Therefore, it is necessary to establish a raw material procurement evaluation and management system, select reliable suppliers, and conduct strict inspection and evaluation of raw materials to ensure that their quality meets standard requirements.
2. Production process control: The production process of in vitro diagnostic reagents should be subject to strict standardized management, including standard operating procedures, production flow charts, production equipment verification, etc. Ensure the consistency and stability of each production batch by fully understanding key process steps and parameter control requirements.
3. Quality testing and verification: In vitro diagnostic reagents require multiple quality testing and verification to ensure that the product meets standard requirements. Common testing items include physical and chemical properties, functional performance, stability, contaminant detection, etc. At the same time, appropriate quality standards and reference methods need to be established, and instrument equipment verification and calibration need to be carried out.
4. Batch record management: The production of in vitro diagnostic reagents requires complete and accurate batch records to record the operations and results of each production link. Review and management of batch records helps identify and correct potential problems in a timely manner and trace product quality and compliance.
5. Adverse event management: Quality control of in vitro diagnostic reagents also includes the management and handling of adverse events. The tracking, investigation and formulation of corrective actions for adverse events can help improve product quality and avoid similar problems from happening again.
3. Product standards and specifications:
Quality systems for in vitro diagnostic reagents involve the development and compliance with applicable product standards and specifications. These standards and specifications include technical specifications for product design and development, clinical verification requirements, quality control methods and limits, labels and instructions, etc., to ensure that the reagents comply with relevant regulatory and technical requirements. The main contents are:
1. National standards: In vitro diagnostic reagents in China need to comply with relevant standards promulgated by the state, such as "Medical Immunology Reagents-Enzyme-Linked Immunosorbent Assay Detection Principles" (GB/T 21414), "Medical Immunology Reagents-Radioimmunoassay Test" Detection Principles" (GB/T 21415), etc.
2. International standards: In vitro diagnostic reagents can also refer to relevant international standards, such as ISO 9001 (quality management system), ISO 13485 (medical device quality management system) of the International Organization for Standardization (ISO), etc.
3. Medical device registration requirements: According to China’s Medical Device Supervision and Administration Law and relevant regulations, in vitro diagnostic reagents need to be registered and meet registration requirements, including product quality, performance, safety, clinical effectiveness, etc.
4. GMP requirements: Manufacturers of in vitro diagnostic reagents need to comply with the requirements of the Good Manufacturing Practice for Medical Devices (GMP), including requirements for factory facilities, production processes, quality control, personnel training, etc., to ensure product quality and Compliance.
5. Guidelines and standards of relevant industry associations: For in vitro diagnostic reagents, you can also refer to the guidelines and standards issued by relevant industry associations, such as the "In Vitro Diagnostic Reagents Quality Control Guidelines" of the China Medical Device Industry Association.
In addition to the above standards and specifications, different countries and regions may also have other specific requirements, such as European CE certification, US FDA registration, etc. In order to ensure the quality and safety of in vitro diagnostic reagents, manufacturers need to conduct comprehensive technical evaluation and verification of the products, and strictly follow relevant standards and specifications for production and sales. At the same time, relevant regulatory agencies will also conduct regular spot checks and inspections to ensure the compliance and stable quality of in vitro diagnostic reagents.
4. Adverse event reporting and tracking:
In vitro diagnostic reagent manufacturers should establish a sound adverse event reporting and tracking management system. Once adverse reactions, mistests and other problems are discovered during the use of reagents, corrective measures and reporting mechanisms should be taken promptly and reported to regulatory agencies as required. At the same time, it is also necessary to track and re-evaluate information on product safety issues on the market to ensure the long-term safety of the product.
First of all, in vitro diagnostic reagent adverse event reporting refers to reporting any abnormalities, quality problems, accidents or accidents that occur during the use of in vitro diagnostic reagents. These adverse events may include, but are not limited to, poor reagent performance, reagent contamination, reagent batch problems, etc. The report should include specific information about the relevant reagents (such as product name, batch number, production date), detailed description of the adverse event, time of discovery, scope of impact, and emergency measures that have been taken.
Secondly, adverse event tracking of in vitro diagnostic reagents refers to further investigation and follow-up management of adverse events after reporting. The purpose of tracking is to identify the root cause of adverse events, avoid recurrence of similar events and take appropriate corrective measures. The tracking process involves detailed recording of events, on-site investigation, discussion and analysis, and supervision of the implementation of follow-up measures. Tracking should be completed within a certain time frame and ensure that appropriate corrective actions are taken to prevent similar incidents from happening again.
In order to effectively report and track adverse events of in vitro diagnostic reagents, it is usually necessary to establish a sound quality management system and reporting mechanism. This includes standardized adverse event reporting procedures, personnel specifically responsible for handling adverse events, strict recording and archiving systems, and regular review and evaluation mechanisms. At the same time, adverse events need to be reported to relevant regulatory authorities in a timely manner and actively cooperate with regulatory authorities in their investigations and related work.
5. Process verification and verification evaluation:
In vitro diagnostic reagent manufacturers should verify product technology and processes, and determine the rationality and feasibility of process parameters through verification and evaluation. Verification and evaluation generally include equipment verification, process parameter verification, raw material verification, environmental condition verification, performance evaluation verification, etc. to ensure product quality and stable performance.
By establishing a scientific and reasonable quality system, in vitro diagnostic reagent manufacturers can effectively manage product quality and ensure product reliability and safety. At the same time, regulatory agencies will also conduct irregular audits and inspections based on the operation of the quality system to ensure that companies comply with quality management specifications and regulatory requirements.
