What does GSP’s unannounced inspection mean?

GSP's unannounced inspection refers to inspection: traceability check, quality risk control check of fake and inferior drugs, operation check, on-the-job check, cold chain check, whether the source of drug procurement is forged, and purchase and sales check.

1. Check and trace. In particular, check whether the traceability system for vaccines, special drugs, blood products, and national centralized drugs is complete.

2. Check for quality risk control of counterfeit and substandard drugs. Check the business scope, recent drug inventory management, and automatic control of drug validity period. In addition, drug packaging and properties are inspected in strict accordance with GSP requirements.

3. Check the operation. Whether to provide premises, qualification documents, bills and other conditions for others to illegally operate drugs; purchase drugs from individuals or units without a "Drug Production License", "Pharmaceutical Business License", enterprises or institutions without a "Drug Registration Certificate"; Selling drugs to units or individuals without legal qualifications, knowing or should know that others are engaged in unlicensed operations but still providing them with drugs.

4. Check on duty. Whether the company's quality director and quality management personnel are on duty in their performance of duties; whether the practicing pharmacists are certified.

5. Check the cold chain. The enterprise's cold chain drug management situation, whether the drug storage and transportation records are complete and authentic; whether the temperature and humidity monitoring of drug storage, transportation, and temperature are not carried out as required; whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time.

6. Whether the source of drug procurement is falsified, the sales flow of drugs is fabricated, the computer system and temperature and humidity monitoring system data are tampered with, and the true drug purchase and sale records, bills, vouchers, data, etc. are concealed, and the drug purchase and sale records are incomplete. , untrue, and business activities cannot be traced.

7. Check purchases and sales. When purchasing and selling drugs, the certificates (license certificates), tickets (invoices, notes accompanying the goods), accounts (physical accounts, financial accounts), goods (physical medicines), and payments (payments) cannot be consistent with each other; the medicines are not put into the warehouse, and the establishment Off-the-books accounts, drugs not being included in the company's quality management system, and personal bank accounts being used for business transactions.

Issues that should be paid attention to when filling in the certification application form

1. The company name filled in must be consistent with the name of the business license and business license mark applied for in accordance with the law; it must be consistent with the name on the cover of the application form The stamped official seal of the company is consistent. If changes occur, relevant supporting documents should be attached.

2. The address, business method, business scope and other items filled in must be consistent with the content marked on the business license. Prevent arbitrariness in filling in and even concealment or misreporting.

3. Technical title of the legal representative. Identify the contact person. Description of the basic situation of the enterprise: the history of the establishment of the enterprise; a brief description of the current situation of the enterprise.