Medical network on December 19 - on December 16, national food drug safety administration issued a "drug-handling guiding principles and the quality control standard for on-site inspection, the project of the GSP inspection defects and determine the results of rules and instructions.
, according to notice of the changes of the content modification improved the drug supply and the quality control standard for on-site inspection guidelines "the first part of the pharmaceutical wholesale enterprises relative clauses and the second part of the pharmaceutical retail enterprises, added a third part of the in vitro diagnostic reagents (drug) enterprise".
▍ 18 serious defect, withdraw the minefield untouchable!
According to the principle of the supervision and inspection results to determine whether the wholesale business, retail enterprises or in vitro diagnostic reagent, as long as one serious defects in the inspection project, will be "one ticket veto", judged to be a serious violation of the GSP, revocation of GSP certificate!
According to the blue parker, pharmaceutical wholesale enterprises, retail enterprises serious defect inspection program is as follows:
Pharmaceutical wholesale enterprises:
* * 00201 an enterprise shall in drug purchase, storage, sale, transport and other link to adopt effective quality control measures, to ensure drug quality, and establish the traceability system according to relevant requirement, and implement drug traceability.
* * 00401 pharmaceutical trading enterprises shall operate in accordance with the law.
* * 00402 pharmaceutical trading enterprises shall adhere to honest and trustworthy, prohibit any false and deception.
* * 03101 enterprise quality management system documents shall be complete, and conforms to the enterprise actual, documents including the quality management system, department and responsibility, operation procedures, records, reports, records and documents, etc.
* * 04902 to store vaccines, shall be equipped with two or more independent cold storage.
* * 05805 corporate computer systems should be in accordance with the specification requirements and the actual requirement of enterprise management application software and related database.
* * 06101 legal qualifications for purchasing drug supply units shall be determined; Determine the legitimacy to buy drugs; Verify supply unit sales staff legal qualifications.
* * 06601 enterprises purchasing drugs shall be submitted to the suppliers ask for the invoice.
* * 06701 on the invoice of purchase, sales, commodity unit name and the amount should be consistent with the flow, commodity and the amount of payment, and with the content of the financial accounts.
* * 09101 companies sell drugs of invoices shall truthfully, do vote, zhang, cargo, consistent.
Pharmaceutical retail enterprises:
* * 00201 an enterprise shall in drug purchase, storage, sale, transport and other link to adopt effective quality control measures, to ensure drug quality, and establish the traceability system according to relevant requirement, and implement drug traceability.
* * 00401 pharmaceutical trading enterprises shall operate in accordance with the law.
* * 00402 pharmaceutical trading enterprises shall adhere to honest and trustworthy, prohibit any false and deception.
* * 12101 an enterprise shall have its business scope and scale that meet the needs of business conditions, including organization, personnel, facilities, equipment, quality management files, and set up a computer system in accordance with the relevant provisions.
* * 14504 operating refrigerated drugs, have special refrigeration equipment.
* * 14807 refrigerated drugs, it shall have its corresponding to the scale of operation and operation.
* * when purchasing drugs, 15209 enterprises to obtain invoices shall be submitted to the suppliers.
* * 15211 on the invoice of purchase, sales, commodity unit name and the amount should be consistent with the flow, commodity and the amount of payment, and with the content of the financial accounts.
▍ general defects, is also a time bomb!
Don't assume that if only the main defect and general defect, can avoid from card, according to the regulation, if reaches a certain number of, die, was identified as a serious breach of drug GSP, revocation of GSP certificate!
Pharmaceutical wholesale enterprises:
1, the main defects project is greater than or equal to 10;
2 project, the main defects is less than 10, the general defects project is greater than or equal to 29.
Pharmaceutical retail enterprises:
The defect project is greater than or equal to 1, 5;
Article 2 project, the main defects is less than 5, general defects project is greater than or equal to 23.
▍ drug was removed from the rate is as high as 62.5%.
Fly in the agency's strict inspection, the GSP withdrawal syndrome, the rate is reached record high. According to incomplete statistics, in the first half of this year the country has only 117 drug GSP certificate has been revoked. For example, the jinan food drug administration in 31 July 28, flew to check the 16 druggist, eventually, cancellation, recover the GSP certificate 10 withdraw the pass rate of 62.5%.
In circulation industry the most strict regulation under the storm, the drug inspection will also be more frequent, below is the blue parker finishing part of the drug was withdrawn in the flying inspection GSP high frequency problems. For manufacturers and haven't met fly check storm, must avoid the following problem, once the violation will likely be retrieved or even withdraw, for reference:
A, temperature problems
1, enterprise warehouse temperature control system is not open excess temperature alarm Settings, and the temperature alarm limit is set to 35 ℃.
2, on-site inspection, all warehouse temperature at 30 ℃ above, not according to the stipulation of "pharmacopoeia of the law of the People's Republic of China on the temperature requirements set appropriate warehouses. Drug maintenance staff not to warehouse temperature control effectively.
3, on-site inspection, the enterprise of a cool library temperature more than 28 ℃.
4, individual cold chain drug heat preservation measures in the process of transportation has failed to meet the requirements of the temperature control of the drug.
Second, drug sales
1, not according to approved by the licensed content in pharmaceutical trading activities
2, the company sales countries have special management requirements of drug use cash transactions.
3, enterprise kangaroo warehouse storing drugs, not according to approved by the licensed content in pharmaceutical trading activities.
4, illegal sales of pure hemp products. On May 1, 2015, including codeine compound oral liquid preparation agent (including oral solution, syrup) listed in the second category of psychotropic drugs management. Many pharmaceutical trading enterprises, have been found out.
Third, Chinese medicine yinpian problem
1, Chinese medicine yinpian source is not clear
2, storage conditions do not conform to the rules, for example, proprietary Chinese medicine in Chinese medicine yinpian library
3, enterprise business scope "Chinese medicine", Chinese traditional medicine warehouse set (room temperature) on the sixth floor, not set a cool library traditional Chinese medicine.
Fourth, drug storage problem
1, outside permission warehouse storage of drugs.
2, qualified drugs on unqualified area.
3, warehouse management chaos, medicines, grounding piled up against the wall directly, stair stacked drugs, sundries warehouse.
4, health care products and medicine
Five, the invoice issue
1, enterprise purchasing medicine fails to supply unit for the invoice.
2, the company sales drugs not invoice.
3, not listed enterprise sales of ordinary VAT invoice details of the agreement with sales outbound single-phase and attached the list of selling goods or providing taxable services.
4, Chinese medicine yinpian procurement not unit for the invoice to the supplier; Chinese medicine yinpian sales did not issue the VAT invoice or the ordinary VAT invoices;
Six, the informationization management issues
1, illegal warehouse using computer management system and enterprise quality control department of the quality management system is not connected to the Internet, for ins and outs of drug information completely, there are multiple computer management system, multiple sets of accounts.
2, the enterprise computer system shows that drugs is inconsistent with the actual inventory.
3, enterprises set up a computer system do not conform to the requirements of the business process management and quality control.
4, enterprise warehouse address not installed a computer system, between the warehouse address and office address cannot achieve information transmission and data sharing.
Seven, quality management issues
1, enterprise on-the-job not on-the-job, director of quality management.
2, the enterprise to its retail stores unified quality management.
Three key elements, the enterprise quality management system has changed much, since 2014, did not carry out internal audit organization.
Eight, product recalls
Not assist drug production enterprise to fulfill its obligations, recall warehouse found national bureau announcement recalled drugs. |
