The pharmacy's strictest inspection is here

The drug administration has begun to formulate the most stringent inspections, and pharmacies will inspect them at least once every three years.
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Retail pharmacies, check at least once every 3 years

Retail pharmacies, check at least once every 3 years

On November 8, the Shanxi Provincial Drug Administration issued the "Implementation Rules for Drug Inspection and Administration of Shanxi Province (Trial)" (Draft for Solicitation of Comments) (hereinafter referred to as the "Rules") to regulate drug inspection behavior
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The "Detailed Regulations" stated that this document is applicable to the inspection, investigation, evidence collection, and disposal of Shanxi Province's drug production, operation, and use by the drug supervision and administration departments at all levels in Shanxi Province
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It can be seen that the scope of implementation of the "Rules" covers the field of retail pharmacies

The "Detailed Rules" clearly requires that the provincial drug regulatory bureau (hereinafter referred to as the provincial bureau) conduct related inspections for drug retail chain headquarters, third-party drug online trading platforms, drug wholesale companies, drug manufacturers and other units, and the provincial bureaus shall check the drug safety risks Take effective risk control measures to organize the investigation and punishment of the above-mentioned corporate violations of laws and regulations and major cross-regional violations of laws and regulations
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The relevant inspections of pharmaceutical retail enterprises in the administrative area are carried out by the city and county drug supervision and administration departments (hereinafter referred to as the municipal bureaus)
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In addition, the "Detailed Rules" gives specific inspection frequencies for various pharmaceutical companies:

1.
Compliance inspection of regional wholesale enterprises of narcotic drugs and first-class psychoactive drugs and wholesale enterprises of raw materials of pharmaceutical precursor chemicals shall be inspected not less than once every six months;

2.
The compliance inspection of vaccine distribution companies shall be no less than once a year
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3.
The compliance inspections of designated business enterprises (including retail enterprises) of psychotropic drugs, anabolic agents, peptide hormones, radiopharmaceuticals, and medical toxic drugs are not less than once a year
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4.
The compliance inspections of other pharmaceutical business enterprises shall be supervised and inspected at least once every three years;

5.
The management of purchasing and storing medicines in medical institutions shall be supervised and inspected at least once every three years
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The drug supervision and administration departments at the city and county levels may determine the frequency of inspections for drug retail enterprises and users based on the risk assessment of drug management in their respective administrative regions
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The 3 most stringent inspections, all involving pharmacies

The 3 most stringent inspections, all involving pharmacies

According to the information in the "Detailed Rules", the provincial bureau is responsible for establishing a team of professional and specialized drug inspectors and formulating specific management measures
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The nature and purpose of drug inspections can be divided into licensing inspections, routine inspections, due-cause inspections, and other inspections, all involving retail pharmacies

Licensing inspection: The administrative examination and approval department shall review the application materials in accordance with the determined and announced licensing items, licensing procedures and licensing requirements in accordance with laws and regulations.
If on-site inspection is required, an inspection plan shall be formulated and implemented, and within the prescribed time limit for licensing Make administrative licensing decisions within
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There are two conclusions of the comprehensive evaluation of the license inspection: 1.
Administrative licenses can be granted if the requirements are met and those that basically meet the requirements have been rectified; 2.
Administrative licenses should not be granted if the requirements are not met
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In addition, for the on-site inspection of the license, the relevant departments shall conduct a graded assessment of the defects found in the inspection of the drug and drug business, put forward the on-site inspection conclusions and take risk control measures to deal with recommendations, and form the on-site inspection report and the "Inspection Unqualified Items List" , And report the on-site inspection to the inspected unit.
After the "Inspection Unqualified Items List" is signed and confirmed by the inspected unit, the inspected unit shall explain to the inspected unit the rectification requirements for the defective items in the on-site inspection of drugs
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It is worth mentioning that the "Detailed Rules" require that the unit that receives the rectification report should review the rectification report submitted by the inspected unit within 7 working days.
If necessary, it can conduct an on-site inspection on the implementation of the rectification of the inspected unit, and Form a written audit report
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For defective items listed in the rectification plan that cannot be rectified on time, the drug supervision and management department shall follow up until the rectification is completed, and confirm that all the rectifications for inspection defects are completed

For units under inspection that take risk control measures or file a case for investigation and punishment, the drug regulatory department must select an inspection team to conduct on-site inspections of their rectification, confirm that the rectification meets the requirements, remove the relevant risk control measures, and announce the results to the public in a timely manner
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From the above content, it is not difficult to see that after the relevant departments have implemented the permit inspection on the pharmacy, the management will undoubtedly become more stringent
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Routine inspections: The drug supervision and administration department formulates annual inspection plans for medicines based on risk management principles, combined with risk assessment and other conditions, and organizes routine inspections
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Routine examination is divided into daily supervision and inspection, compliance checks (compliance checks), extending inspection

The results of routine inspections and other inspections are as follows: meet the requirements, basically meet the requirements, and do not meet the requirements
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1.
Meet the requirements: no need to take risk prevention and control measures;

2.
Basically meet the requirements: The drug supervision and administration department responsible for the supervision of the inspected unit shall conduct a risk assessment within 7 working days after receiving the "Drug Inspection Comprehensive Evaluation Report".
If there is evidence that there may be a hidden safety hazard, it shall In accordance with the "Pharmaceutical Administration Law of the People's Republic of China" and other regulations, risk control measures such as warnings, interviews, and rectification within a time limit are adopted
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3.
Non-compliance: The drug supervision and administration department responsible for the supervision of the inspected unit shall conduct a risk assessment within 7 working days of receiving the "Comprehensive Evaluation Report of Drug Inspection", if the drug has quality problems or other major safety hazards , In accordance with Article 99 of the "Pharmaceutical Administration Law of the People's Republic of China", risk control measures such as suspension of production and sales shall be adopted to eliminate potential safety hazards
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At the same time, the inspected unit is ordered to conduct a comprehensive review and analysis of the risks of listed drugs, to take measures such as recalls in accordance with laws and regulations, and to conduct investigations and punishments in accordance with Article 126 of the Drug Administration Law of the People's Republic of China

According to Article 126 of the "Pharmaceutical Administration Law of the People's Republic of China": If a pharmaceutical business enterprise fails to comply with the pharmaceutical business quality management norms, it shall be ordered to make corrections within a time limit and be given a warning; if it fails to make corrections within the time limit, it shall be fined 100,000 yuan to 500,000 yuan If the circumstances are serious, a fine of not less than 500,000 yuan but not more than 2 million yuan shall be imposed, and production and business shall be suspended for rectification until the drug business license is revoked
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Reasonable inspection: The inspection should be carried out without prior notice, and the local drug supervision and administration department of the inspected unit can be notified to assist in the inspection according to the needs of the inspection
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If the drug supervision and administration department needs to conduct inspections for reasons after risk assessment, it shall determine the inspection focus based on the source of inspection clues, formulate inspection plans, select inspectors, and if necessary, select inspection, inspection, financial or other departments to form a joint inspection team to conduct inspections
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Disposal due to the results of the inspection can be divided into the following two situations:

1.
If the problems involved in the inspection are not clearly verified, and it is necessary to further initiate an extended inspection, joint inspection, or co-investigation, further investigation, verification and handling opinions shall be made
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2.
The problems involved in the inspection reasons have been verified clearly.
If the company has any violations of laws and regulations, it shall be dealt with in accordance with laws and regulations; if there is only a drug quality management defect, it shall be dealt with in accordance with the routine inspection method
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The most stringent inspection of pharmacies, implemented nationwide

The most stringent inspection of pharmacies, implemented nationwide

In fact, the State Food and Drug Administration announced the "Administrative Measures for Drug Inspection (Trial)" (hereinafter referred to as the "Measures") on May 28
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The "Measures" clearly requires that, in order to further regulate drug inspection behavior and promote drug supervision work to adapt to the new situation as soon as possible, all provincial drug supervision and administration departments shall, in accordance with the requirements of the "Measures", and in light of the actual conditions of their respective administrative regions, formulate detailed implementation rules and refinements.
Work requirements, organize inspections of drug production, operation and use
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In addition, the "Measures" also mentioned in detail the licensing inspections, routine inspections, and due-cause inspections including retail pharmacies
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Pharmacy permit inspection

Pharmacy permit inspection

For the first application for the "Pharmaceutical Business License" and the application for the "Pharmaceutical Business License" for changes in licensing items and on-site inspections are required, on-site inspections shall be carried out in accordance with the GSP and its on-site inspection guidelines, licensing inspection rules and other relevant standards
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Those who apply for the re-issuance of the "Pharmaceutical Business License" will be reviewed in accordance with the risk management principles based on the company's compliance with drug management laws and regulations, GSP and quality system operations, and GSP compliance inspections can be carried out when necessary
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Regarding the licensing inspection of pharmaceutical retail chain enterprises, if the number of enterprise stores is less than or equal to 30, a random inspection shall be conducted at a rate of 20%, but not less than 3; if there are more than 30, a random inspection shall be conducted at a rate of 10%, but not less than 6 Home
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The drug supervision and administration department of the city and county level where the store is located shall cooperate with the provincial drug supervision and administration department or the drug inspection agency that organizes the license inspection to carry out the inspection
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If the random-checked drug retail chain stores are established across provinces (autonomous regions, municipalities directly under the Central Government), when necessary, the provincial drug supervision and administration department that organizes licensing inspections may carry out joint inspections

Routine inspections in pharmacies

Routine inspections in pharmacies

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Other content that the drug supervision and administration department considers to be inspected
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Drugstore due to inspection

Drugstore due to inspection

Under one of the following circumstances, the drug regulatory authority may conduct a due-cause inspection after risk assessment:

1.
Complaints, reports or clues from other sources indicate that there may be a quality and safety risk;

2.
The inspection finds that there are quality and safety risks;

3.
Adverse drug reaction monitoring suggests that there may be quality and safety risks;

4.
There are doubts about the authenticity of the declared materials;

5.
Suspected of serious violation of relevant quality management regulations;

6.
The company has a record of serious non-compliance;

7.
The enterprise frequently changes the registration items of management personnel;

8.
Potential safety hazards are found in the batch issuance of biological products;

9.
The inspection finds that there are hidden dangers in the safety management of special drugs;

10.
Special drugs are suspected of flowing into illegal channels;

11.
Other situations that require inspections for reasons
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