Cross-checking of medical device operations is more horrible than flying inspection

What is the ghost of cross-checking in different places?

In the specific implementation policies issued by the provincial food and drug administrations, they have also proposed to carry out rectification by means of cross-examination. The industry often talks about the color change of the flight inspection. However, how do you check the cross-checking in different places? What does it have to do with flight inspection?

In general, off-site cross-checking is conducted in conjunction with flight inspections. To put it simply, the law enforcement officers of the Food and Drug Administration do not participate in the inspection of pharmaceutical and medical device business enterprises in the county (city, district) area during the flight inspection, and participate as observers.

In this way, it not only rectifies the medical device market, but also provides opportunities for drug supervisors to learn from each other and learn from each other.

In the work plans for the management of medical device circulation in the provinces, some of them have also proposed cross-checking and coordinated flight inspections, but more are only cross-checks.

For example, recently, the Guangxi Autonomous Region issued a work plan for the management of medical device circulation in the field of deployment: from August 20 to September 20, 2016, the Autonomous Regional Bureau organized five cross-inspection groups, and the cross-inspection team consisted of The Medical Device Supervision Department, the three departments directly under the Bureau, and some city bureau personnel are responsible for cross-supervising the situation of rectification work in each city.

Because the current major rectification of medical device management behavior is only in the self-inspection stage of the enterprise, and no direct and specific reference object can be found. However, the Nanchong City Food and Drug Administration recently issued the "Nanchong City drug circulation field cross-examination inspection law enforcement inspection implementation plan", detailed cross-examination inspection, can be used as a reference for the medical device industry :

Nanchong City cross-checking organization

(1) The Municipal Bureau has transferred two auditing law enforcement personnel from each county (city, district) bureau to conduct cross-checking in three groups, requiring one to have GSP certification inspection experience and one to have drug inspection and law enforcement experience. In principle, the law enforcement personnel who are transferred shall not participate in the inspection of pharmaceutical business enterprises within the jurisdiction of the county (city, district), and participate as observers.

(2) The inspection enterprise shall adopt two methods of prior determination and random determination. The inspection enterprise determined in advance shall not inform the inspector in advance, and notify the local county (city, district) bureau and the enterprise to be inspected in advance; The retail enterprise is randomly determined after the scene.

(3) Immediately after the inspector arrives at the scene, the on-site inspection shall be carried out, and at least 2 to 4 drug purchase and sales enterprises related to the upper and lower business shall be traced back.

(4) The inspection enterprise randomly determined by the inspection team may be independent of the list, the time limit, and the number of enterprises determined by the municipal bureau.

(5) The Food and Drug Inspection Detachment of the Municipal Bureau is responsible for the arrangement, organization, coordination and inspection of the cross-checking, formulating the implementation plan, supervising the implementation of the plan, supervising the on-site inspection, reviewing the inspection report; and being responsible for investigating or transferring the illegal activities of the enterprise. .

Cross-site inspection requirements

(1) According to the "Drug Administration Law" and the "Guidelines for On-site Inspection of Pharmaceutical Management Quality Management Regulations" issued by the State Administration of the People's Republic of China, the cross-checking work must follow the principles of law, prudence, timeliness, objectivity and fairness.

(2) The inspectors shall dress according to the regulations, demonstrate law enforcement, civilized law enforcement, and standardize law enforcement, so that the procedures are legal. It is strictly forbidden to go through the field and take the form. The units to be inspected must carry out inspections seriously, make inspection records, fix illegal evidence, and ensure the effectiveness of inspections.

(3) The general illegal acts found during the inspection shall be transferred to the local Food and Drug Administration for investigation and punishment by the Municipal Bureau, and the major violations shall be investigated and handled by the Municipal Bureau. The suspected crimes shall be transferred to the judicial authorities for investigation and punishment.

Functional Food Ingredients

Shaanxi Kang New Pharmaceutical co., Ltd. , https://www.anabolicsteriod.com