I transferred to a pharmacy in Zhongshan, and the GSP certification will expire in a few months. How can I pass the certification again?

If the licensed items of the Drug Business License change, such as the legal representative, the person in charge of quality, the business scope, etc., it needs to be certified according to the newly opened pharmacy, which is more stringent.

If there is no change, it is easier to apply for a replacement card when it expires.

If the license has not been changed but needs to be changed, the change can be synchronized with GSP certification, but the validity of the two certificates should be within 6 months. (Specific provisions shall be subject to local regulations)

Certification related matters:

Apply to the local food and drug administration for replacement, and provide qualification materials according to the requirements of replacement.

According to the local US Food and Drug Administration GSP certification on-site inspection operation method (suggestion), check whether the following contents are perfect:

1. Management responsibilities (quality management system, procedures and responsibility documents; The establishment of the management organization, personnel appointment documents)

2. Personnel (education and training files, employment certificates or qualification certificates of employees in each position; Professional title certificate and appointment letter of quality management personnel; Health check file)

3 facilities and equipment (whether the corresponding facilities and equipment data and use records are complete)

4. Procurement (procurement plan, first-time enterprise, first-time variety, qualified supplier files, procurement documents, etc.). )

5. Acceptance (whether the record is complete, whether the signature is complete, etc. )

6. Storage and maintenance (classified placement, disassembly, etc.). ); Display maintenance, temperature and humidity records, etc. )

7. Sales and after-sales (bill management, prescription review and registration, tracking service, etc.). )

8. Personnel on-the-job situation

9. Collect, analyze and summarize all kinds of information; Plans, records and summary reports of various inspections and reviews.

10. Store service slogan and supervision telephone number; Whether the advertisement meets the requirements, etc.

For the defects found during the on-site inspection in Certification staff, try not to excuse and excuse (you can ask Certification staff how to standardize). If the defects can be rectified on site, immediately arrange personnel to complete the rectification and let Certification staff confirm it again; If the rectification cannot be made on site, someone should be sent to the site to start the rectification. This is an acknowledgement of Certification staff's work and an attitude towards the rectification movement, which is very important.