Cases of unqualified flight inspections and key review points - Product design and development

Product design and development is the process of exploring and probing the product's mechanism of action, process, intended use, risk analysis, and process technology transformation. It is a key link in the product realization process and determines the inherent characteristics of product quality, safety, and effectiveness. Therefore, the compliance of product design and development is also one of the focuses of flight inspections. This article only lists 5 common unqualified cases in flight inspections, and comprehensively analyzes the key review points of documents in flight inspections from point to surface, for reference only by industry insiders.

1. There are no records of design and development input, or the input content is inconsistent with the output.

2. There are no records of the design and development process and related reviews at each stage.

3. During the design and development planning, there is a lack of review and verification activities at the design and development stage.

4. The internal standard for production is repeatedly frozen and thawed, and the company does not specify the number of freeze-thaw cycles.

1. Design control procedures

Planning should include seven steps: design input, design output, design conversion, design review, design verification, design confirmation, and design change.

2. Planning

The design and development stages, as well as the responsibilities, reviews, and authorities of personnel, as well as the review, verification, confirmation, and design conversion activities suitable for each design and development stage should be determined.

3. Risk management

Risk management runs through the entire product life cycle, and risk control and risk analysis must be carried out throughout the product process. When changes in the selected materials, parts, or product functions may affect the safety and effectiveness of medical device products, the risks that may be caused by the changes should be evaluated.

Risk management documents and records shall at least meet the following requirements: Risk management shall cover the entire process of product development by the enterprise; documents for risk management of medical devices shall be established, and relevant records shall be maintained to determine evidence of implementation; risks of medical device products shall be controlled at an acceptable level; when deviations from the plan require modification of the plan, the plan shall be reviewed and approved again; research and development site assessment, including research and development site and conditions and facilities, raw material selection, source, indicators, process parameters, technical requirements, quality standards, instructions for use, test samples, etc. in the research and development process shall be true, complete, and traceable.

4. Design and development output materials

At least meet the following requirements: procurement information, such as technical requirements for raw materials, packaging materials, components and parts; information required for production and service, such as product drawings (including component drawings), process formulas, operating instructions, environmental requirements, etc.; product technical requirements; product inspection procedures or instructions. Specify the product characteristics necessary for the safety and normal use of the product, such as product instructions, packaging and labeling requirements, etc.; product instructions are consistent with registration declaration and approval; identification and traceability requirements; documents submitted to the registration and approval department, such as research materials, product technical requirements, registration inspection reports, clinical evaluation materials (if any), list of basic requirements for medical device safety and effectiveness, etc.; biological evaluation results and records, including the main performance requirements of materials.

5. Changes

(1) Changes are an inherent part of the R&D process and should be recorded. The degree of change management should be enhanced as product R&D continues to advance.

(2) Any changes that may affect product quality or reproducibility must be effectively controlled, including but not limited to: raw materials, labels and packaging materials, formulas or prescriptions, production processes; production environment, plant equipment and public systems, verified computer systems; quality standards, inspection methods, product shelf life/storage conditions; cleaning and disinfection methods; addition or cancellation of product varieties and specifications, etc.