1, business license of enterprise as a legal person;

2. Business license;

3, enterprise organization code certificate;

4. Enterprise tax registration certificate;

5. Quality management system documents, including quality manuals, program documents and work instructions. ;

6, drugs or medical devices production license or import license;

7, production or storage premises of the housing property certificate or lease contract;

8. Employee files and training records;

9, drugs or medical devices quality inspection report, product quality standards and other related information

The steps of GSP certification are as follows:

1 for GSP certification requirements. Before applying for GSP certification, you need to know the local GSP certification requirements and processes. GSP certification requirements may be different in different countries and regions. You can consult the local GSP certification body or lawyer to better understand the specific requirements and procedures;

2. Prepare materials. Prepare relevant enterprise information and quality management documents according to local GSP certification requirements. Specific materials include business license of enterprise legal person, production license or import license, house property certificate or lease contract of production or storage place, employee files and training records, quality management system documents, etc.

3. Entrust GSP certification body to conduct audit. When selecting a certification body for audit, it is generally necessary to apply to the certification body, fill in the application form and other related materials, and pay the corresponding audit fees. The certification body will conduct on-site audit, including the equipment and facilities, production management and quality management of the enterprise;

4. Evaluate the audit results. According to the audit results, the certification body evaluates the GSP certification of the enterprise, and issues a GSP certification certificate if it meets the requirements. Do not meet the requirements, to rectify the problem, re submitted for review;

5. Review regularly. Generally speaking, the GSP certificate is valid for three years. During the validity period, regular review is needed to ensure that the quality management of the enterprise meets the GSP certification requirements.

The scope of acceptance of GSP certification includes:

1, pharmaceutical retail enterprise;

2. Anyone who meets all the following conditions may apply:

(1) A pharmaceutical trading entity that falls into one of the following circumstances: a pharmaceutical trading enterprise with the qualification of an enterprise legal person; Pharmaceutical trading enterprises owned by enterprises as legal persons that do not deal in pharmaceuticals; A pharmaceutical business entity that does not have the qualification of an enterprise as a legal person and has no superior competent unit to undertake the responsibility of quality management;

(2) Having a Pharmaceutical Business License and a Business License for an Enterprise as a Legal Person or a business license;

(3) After internal audit, the enterprise basically meets the conditions and requirements stipulated in the Quality Management Standard for Pharmaceutical Trading and its detailed rules for implementation;

(4) Within 12 months before the application for certification, the enterprise does not have the problem of distributing counterfeit and inferior drugs due to illegal operation (subject to the date of administrative punishment given by the food and drug supervision and administration department, the same below).

To sum up, GSP refers to the quality management standards of medical and health products such as drugs and medical devices. GSP certification requirements may be different in different countries and regions, and preparations should be made according to local specific requirements. If GSP certification is needed, it is recommended to consult a professional GSP certification institution or lawyer to better understand the specific requirements and processes.

Legal basis:

"Regulations for the implementation of the Drug Administration Law of People's Republic of China (PRC)" thirteenth

The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government and the municipal pharmaceutical supervisory and administrative institutions with districts are responsible for organizing the certification of pharmaceutical trading enterprises. Pharmaceutical trading enterprises shall, in accordance with the implementation measures and steps stipulated by the pharmaceutical supervisory and administrative department of the State Council, be certified by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government or the pharmaceutical supervisory and administrative institutions at the municipal level with districts, and obtain the certification. The format of the certificate of "Good Quality Management Practice for Pharmaceutical Trading" shall be uniformly stipulated by the pharmaceutical supervisory and administrative department of the State Council.

Newly established pharmaceutical wholesale enterprises and pharmaceutical retail enterprises shall, within 30 days from the date of obtaining the Pharmaceutical Trading License, apply to the pharmaceutical supervisory and administrative department or the pharmaceutical supervisory and administrative institution that issued the Pharmaceutical Trading License for the certification of the quality management standard of pharmaceutical trading. The pharmaceutical supervisory and administrative department or pharmaceutical supervisory and administrative institution that accepts the application shall, within 3 months from the date of receiving the application, organize the certification of whether the pharmaceutical wholesale enterprises and pharmaceutical retail enterprises applying for certification meet the "Quality Management Standards for Pharmaceutical Trading" in accordance with the provisions of the pharmaceutical supervisory and administrative department of the State Council; If the certification is qualified, a certification certificate will be issued.