In order to eliminate the hidden dangers of drug safety and strengthen the quality and safety of pharmaceutical production enterprises, on the 17th, Hefei City issued the “Hefei City Drug Manufacturing Company Interview System (Trial)â€. If it is found that there are major safety hazards in pharmaceutical companies, the food and drug administration department will “consult†its relevant person in charge to prevent future problems.
The “Interview System†clarifies that if there are frequent changes in the production and quality management agency personnel, changes in key production facilities, etc., and major hidden dangers in drug safety during the daily supervision and inspection, they will be supervised by the local food and drug administration. The management department "interviews".
The target of the interview is the legal representative, the person in charge of the company, and the person in charge of quality management of the pharmaceutical production company. He hopes to find out the cause of the problem through an interview and order him to rectify the deadline.
Before the interview, the food and drug supervision and administration department will issue a "announcement written notice" to the pharmaceutical company, stating the contents, time and place of the interview. A special person is responsible for recording appointments and interviews may be sent to the relevant units if necessary.
Companies that do not participate in interviews without reason will be included in the bad records of creditworthiness assessment in the same year; drug production companies that refuse to correct mistakes after interviews will be listed as the key regulatory targets and will implement key supervision; drug manufacturers have objections to the content of the interviews. , also have the right to make statements or defenses.
The “Interview System†clarifies that if there are frequent changes in the production and quality management agency personnel, changes in key production facilities, etc., and major hidden dangers in drug safety during the daily supervision and inspection, they will be supervised by the local food and drug administration. The management department "interviews".
The target of the interview is the legal representative, the person in charge of the company, and the person in charge of quality management of the pharmaceutical production company. He hopes to find out the cause of the problem through an interview and order him to rectify the deadline.
Before the interview, the food and drug supervision and administration department will issue a "announcement written notice" to the pharmaceutical company, stating the contents, time and place of the interview. A special person is responsible for recording appointments and interviews may be sent to the relevant units if necessary.
Companies that do not participate in interviews without reason will be included in the bad records of creditworthiness assessment in the same year; drug production companies that refuse to correct mistakes after interviews will be listed as the key regulatory targets and will implement key supervision; drug manufacturers have objections to the content of the interviews. , also have the right to make statements or defenses.
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