In 2020, the National Bureau conducted unannounced inspections on 89 medical device manufacturers, including 44 IVD companies, 16 sterile product companies, 11 active device companies, 9 implant product companies, 3 denture companies, and 3 independent software company and 3 other companies. The reasons for unannounced inspections are compliance inspections, special inspections, unqualified random inspections, complaints and reports, and occurrence of adverse events. The result of the inspection was that 63 enterprises were rectified within a time limit, 12 stopped production for rectification, 8 had stopped production before the inspection and 1 was written off. Among them, 687 failed inspections were mainly concentrated in production management, plant and facilities, equipment and quality control.
In view of the unqualified items of medical device unannounced inspections in 2020, the main problems are analyzed as follows:
1. Organization and personnel
The enterprise is not equipped with full-time inspectors suitable for the products produced;
The person in charge of production and quality is concurrently responsible for each other, and at the same time is responsible for product approval and release;
The production technicians and full-time inspectors have not carried out training that meets the requirements of their positions, and have not seen training content and training records.
2. Plant and facilities
The plant and facilities cannot meet the requirements of product production;
The exhaust air from the air-conditioning system in the positive control room is directly discharged into the air-conditioning mezzanine, and the exhaust duct has no filter device. The positive control room is not maintained negative pressure with the adjacent corridor and other inspection rooms;
The working shoes are cleaned and dried in an operation room in a 10,000-grade clean area. There is no corresponding risk control method. The gas generated in this process is directly discharged outside, and there is no filter device at the return air outlet;
Inadequate warehouse management;
The process water manufacturing equipment is leaking, and a large amount of debris is piled up in the compressed air machine room.
The equipment operating parameters specified in the process regulations are inconsistent with the confirmation report and actual production control parameters;
The speed range of the automatic drug coating machine has not been verified after adjustment, and the company has not specified the reconfirmation cycle;
The maintenance of the independent software development and testing environment is not documented, and there are no requirements for regular verification, updates and upgrades;
Lack of equipment usage and maintenance regulations and records.
4. Document management
The standard operating procedures for inspection of semi-finished products lack preparation methods for positive reference and positive reference nucleic acid extraction and dilution;
Incomplete records of some documents and uncontrolled modification;
5. Design and development
Unable to provide design and development output document records, and the design and development output data is inconsistent with the input requirements;
Design change management is not in place;
The company failed to provide review records of design changes during the product renewal registration phase.
Fail to purchase raw materials in accordance with the established "procurement control procedures", fail to clarify the quality responsibilities of both parties with the main raw material supplier, and the purchase records cannot meet the traceability requirements;
The supplier list does not include major raw material suppliers, fails to provide supplier review reports, review records, and incomplete review records, etc.;
The inspection of incoming materials is not strict.
7. Production management
The enterprise fails to organize production in accordance with the registered process and production process regulations;
The production records are missing or incomplete or inconsistent with regulations, and the production records cannot meet the traceability requirements;
The intermediate products in the production process have no status mark, and no inspection status is marked along with the work order;
The special process is not identified or confirmed, and the verification parameters are inconsistent with the actual operation.
8. Quality control
Some inspection items and inspection methods in the factory inspection procedures are inconsistent with product registration standards or technical requirements;
The "Product Release Procedure" has not been established, and the product release conditions and release standards have not been specified;
A manufacturer of sterile products does not have the ability and conditions to detect sterility and positive controls;
The control level of the initial contamination of bacteria and particulate contamination of the product has not been established, and the storage conditions and requirements of the intermediate product have not been clarified;
It is not possible to provide a report that summarizes and analyzes the trends of various testing records on a regular basis;
Record traceability issues, such as testing records that cannot meet traceability requirements; the generation and use of quality control beads in IVD companies cannot be traced; random inspection of a batch of batch production records does not see irradiation sterilization records, but the products have been sold.
9. Control of unqualified products
The company claims that its products cannot be reworked, but it still retains the content of rework of nonconforming products in its "Control Procedures for Nonconforming Products".
There are 28 unqualified products with sprayed waste in the outer bag in a batch record of the company, and the company has reworked, but no rework record has been seen;
The actual rectification measures are inconsistent with the review records.
10. Adverse event monitoring, analysis and improvement
Failure to establish an adverse event monitoring system in accordance with current regulations;
Failure to implement the recall work in accordance with the required recall plan;
Failure to evaluate the effectiveness of the rectification measures for the identified problems, which does not meet the requirements of the company's "Corrective and Preventive Measures Control Procedures".
The above are the main problems of unqualified medical device unannounced inspections in 2020. It is recommended that companies further enhance their awareness of quality management and risk management; strengthen legal training, continuously improve the quality and level of quality management personnel, and improve the ability to identify risks and control risks; strengthen Self-inspection of the system, continuous improvement and perfection of the quality management system.