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    Home > Medical News > Latest Medical News > A local drug regulatory agency issued a letter of this kind of pharmacies all self-examination.

    A local drug regulatory agency issued a letter of this kind of pharmacies all self-examination.

    • Last Update: 2020-08-08
    • Source: Internet
    • Author: User
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    (Picture source: Intercepted to Anhui Provincial Drug Administration) "Self-inspection notice" requires that special drug enterprises should be june 30 and December 31 each year in accordance with the "special drug business enterprises to implement the main responsibility of self-examination report list" each conduct a self-examination.
    in accordance with the Notice of Self-Examination, special drug management enterprises will conduct self-examination in personnel and training, safety management, storage management, management, mailing and transportation management.
    specific inspection requirements are as follows: Personnel and training 1 enterprise legal person is the first responsible person for the management and safety management of hemp-refined drugs, whether it provides the necessary resources for the safety, quality and safety of special drugs.
    2 Whether the annual hemp-refined drug management business training for managers engaged in hemp-refined drugs and direct business personnel is full of 10, whether targeted training is carried out for different positions and whether the training records are archived.
    Safety Management 1 facilities and measures that have a special drug safety management.
    2 Monitor the device for proper operation.
    3 anesthesia, the first class of psychotropic drugs warehouse, pharmaceutical-type easy-to-use chemicals raw materials warehouse and 110 network alarm equipment is not working properly.
    4 anesthesia, the first class of psychotropic drugs, pharmaceutical-type easy-to-drug chemicals are specially stocked, can effectively prevent theft, fire prevention.
    5 Whether the second class of psychotropic drugs are stored in special libraries or counters, whether the special library or special counters are secure, can effectively prevent theft, fire prevention.
    Warehouse Management 1 Whether there are detailed entry and exit records in and out of the warehouse.
    2 special medicine into the warehouse whether to do the arrival of the goods on the spot inspection.
    3 library or counter s lot performs double lock management.
    4 whether to strictly implement the double acceptance, double review management system, acceptance records whether the double signature.
    5 whether to establish a special account book, fill in the record is standardized, whether the prescribed time limit to be kept.
    6 Special Drug Storage Meets the Requirements for Drug Labeling and Specification Labeling.
    whether to strictly enforce the laws and regulations of special medicines to carry out business activities.
    2 whether to sell fake and inferior drugs.
    3 whether to purchase special drugs from illegal sources.
    4 whether to do not have the operating, use of qualified units to sell special drugs.
    5 Whether to establish a special drug safety management system covering procurement, transportation, acceptance, storage, storage, reporting of damage, destruction and loss, theft case report, on-duty inspection, non-conforming product handling, etc., whether the content is operable, whether the system is revised in a timely manner and implementation.
    6 whether to report the special drug purchase and sale data to the special drug production circulation information reporting system within 7 days after the occurrence of business activities.
    7 Whether the consignee of medical institution on the list of goods with the goods is consistent with the medical institution's record-keeping personnel in the enterprise.
    8 Where there is a case where the first shipment and then the supplement order, the actual quantity shipped is greater than the order.
    9 whether to strictly implement accounts, tickets, goods, payments consistent.
    10 Whether there is a cash transaction situation.
    11 whether to strictly enforce the relevant provisions of the return of special drugs.
    12 Whether the special drugs that are not qualified, such as expired or damaged, are registered, whether the destruction is carried out under the supervision of the drug regulatory authority, and whether the destruction records are completely preserved.
    13 If the regional wholesale enterprises, for special reasons, adjust narcotic strains, the first class of psychotropic drugs and unilateral preparations of pharmaceutical-type easily-toxin chemicals, whether the transfer situation will be filed with the local provincial drug regulatory bureau respectively within 2 days.
    14 Between regional wholesale enterprises whether there is the purchase and sale of pharmaceutical-type easy-to-drug chemicals unilateral formulations and small packaging ephedrine behavior.
    mailing and transportation management 1 Whether the facilities and equipment required for transportation meet the requirements and safety.
    2 whether to handle the shipping certificate, mailing certificate in accordance with the provisions.
    3 Whether the entrusted transport is carried out in accordance with the relevant regulations.
    4 Whether the first class of psychotropic substances, which transports narcotic drugs by road or water, is carried by a person.
    5 whether to send narcotic drugs, the first category of psychotropic drugs, pharmaceutical-type easily-toxin chemicals to medical institutions.
    enterprise self-inspection 1 whether to establish a special drug safety management self-examination system.
    2 self-check report, rectification report is timely uploaded to Anhui Province comprehensive drug regulatory platform enterprise end.
    the "self-examination notice" clear, found problems in a timely manner rectification, to ensure that the main responsibility in place, the safety of special drugs in line with the requirements, and through the Anhui Province comprehensive drug regulatory platform enterprise end report and "enterprise self-check report authenticity commitment." At the same time,
    the provincial bureau dispatching agencies should urge the special drug enterprises in the jurisdiction to seriously organize self-examination, strictly implement the main responsibility, increase the frequency of supervision and inspection of special drug business enterprises that have not carried out self-examination as required;
    attached: Special drug business enterprises to implement the main responsibility of self-examination report list attached: enterprise self-inspection report authenticity commitment.
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