The GSP check is here!

Medical Network News, March 11,
retail pharmacies, GSP inspections are here.
A
few days ago, Zhejiang Province issued the "Notice on Organizing and Carrying out GSP Unannounced Inspections of Drugs in 2021" (hereinafter referred to as the "Notice"), which will further regulate the order of drug distribution and promote Preventing and resolving drug safety risks are institutionalized, standardized and normalized
.
The "Notice" clearly stated that it is necessary to fully implement the "four most stringent" regulatory requirements, adhere to the problem-oriented approach, high-hanging the sharp sword, strengthen the key supervision of key enterprises, key areas and key regions, and strengthen the deterrent effect
.
According to the division of labor in the "Notice", a total of no less than 30 provincial-level unannounced inspections will be arranged in 2021, and each city shall stipulate the number of unannounced inspections in accordance with the three-year full coverage requirement and the actual number of unannounced inspections in the jurisdiction
.
Provincial unannounced inspection objects include those with many defects found in unannounced inspections at all levels in the past two years and incomplete rectification; many changes in licensing items and changes in software and hardware, and many problems found in licensing inspections; and random inspections at all levels of drug supervision Where there are multiple batches of unqualified drugs, in recent years, there have been drug quality and safety accidents or daily supervision and inspection with records of bad behavior; all companies that accept vaccine entrusted delivery; there are reports and complaints that require cause verification; other randomly selected wholesale Headquarters of enterprises and retail chains (the specific list will be notified separately)
.
Municipal flight inspection, all localities should combine the actual area, in addition to the inspection examination of an object, we must also focus on examination of blood products business, special management drugs, imported drugs total agents in high-risk enterprises
.
Unannounced inspections of retail enterprises are organized and arranged by various localities; the inspections are focused on pharmaceutical retail enterprises in rural areas of the urban-rural fringe, and pharmaceutical retail enterprises that carry out online ordering stores and online ordering stores
.

Don’t touchthese 11 red lines
In addition, the "Notice" also clarified 11 key inspection points, which are as follows: 1.
Whether the traceability system of key products (vaccine, special management drugs, blood products, national centralized procurement drugs) is complete; 2.
Quality risks involving counterfeit and inferior drugs Control (business scope, automatic control of drug expiration date, near-expiration drug inventory management, etc.
), whether the inspection of drug packaging and properties is performed in strict accordance with the requirements of GSP; 3.
Whether to provide places and qualification documents for others to illegally operate drugs , Bills and other conditions; purchase drugs from individuals or units without "drug production license" and "drug business license", enterprises or institutions without " drug registration certificate"; sell drugs to units or individuals without legal qualifications, know Or you should know that others are engaged in unlicensed operations and still provide drugs for them; 4.
Whether the company’s quality director and quality management personnel perform their duties on duty; whether the licensed pharmacist is certified; 5.
The company’s cold chain drug management status, drug storage and transportation records Whether it is complete and true; whether the drug storage, transportation, and temperature and humidity monitoring are not performed in accordance with the regulations; whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time; 6.
Whether the source of drug purchase is falsified, the flow of drug sales is falsified, and the computer system and temperature are falsified.
Humidity monitoring system data, conceal real drug purchase and sale records, bills, vouchers, data, etc.
, drug purchase and sale records are incomplete, untrue, and business activities cannot be traced; 7.
When purchasing and selling drugs, certificates (licenses), tickets (invoices, Companion bills), accounts (physical accounts, financial accounts), goods (physical drugs), and payments (payments) cannot correspond to each other; drugs are not stored in the warehouse, an off-book account is set up, drugs are not included in the corporate quality management system, and banks are used Personal account for business transactions, etc.
; 8.
Whether the drug is stored in a place other than the approved address; whether the registered address, business method, and scope of business are changed without authorization to sell drugs; 9.
The temperature and humidity of drug storage and transportation are not monitored according to regulations; 10 1.
Retail companies have problems selling prescription drugs and recalling drugs in violation of regulations; 11.
Other problems involving violations of laws and regulations
.