1, business license of enterprise legal person;
2, business license;
3, enterprise organization code certificate;
4, enterprise tax registration certificate;
5, quality management system documents, including quality manuals, procedural documents, work instructions, etc.
6, drug or medical device production license or import license;
7, production or storage premises housing certificate or lease contract. p>
6, the production license or import license of drugs or medical devices;
7, the house ownership certificate or lease contract of the production or warehousing premises;
8, staff files and training records;
9, the quality inspection report of the drugs or medical devices, product quality standards and other related information
Steps to apply for GSP certification are as follows:
The steps for GSP certification are as follows:< /p>
1, understand the GSP certification requirements. Before applying for GSP certification, you need to understand the local GSP certification requirements and processes. Different countries and regions may have different GSP certification requirements. You can consult your local GSP certification organization or lawyer to better understand the specific requirements and procedures;
2. Prepare materials. According to the local GSP certification requirements, prepare the relevant enterprise information and quality management documents. Specific materials include the business license of the enterprise legal person, production license or import license, production or warehousing premises of the building ownership certificate or lease contract, employee records and training records, quality management system documents, etc.;
3, commissioned by the GSP certification body to carry out the audit. Select the certification body for audit, generally need to submit an application to the certification body, fill out the application form and other relevant information, and pay the appropriate audit fees. The certification body will conduct an on-site audit, the audit includes the enterprise's equipment and facilities, production management, quality management, etc.;
4, the audit results assessment. According to the audit results, the certification body will be assessed on the enterprise GSP certification, if it meets the requirements, then issued GSP certification. If it does not meet the requirements, you need to rectify the problem and resubmit the audit;
5, regular review. In general, the GSP certification is valid for three years. In the validity period, the need for regular review to ensure that the quality management of enterprises in line with the GSP certification requirements.
GSP certification of the scope of acceptance include:
1, drug retailers;
2, meet all of the following conditions, you can apply:
(1) belonging to one of the following circumstances of the drug business unit: a corporate qualification of the drug business enterprises; non-franchise drugs under the drug business enterprises; not with the corporate qualification and without higher competent units Legal person qualification and no superior competent unit to assume responsibility for quality management of drug business entities;
(2) with the "Drug Business License" and "Enterprise Legal Person Business License" or "Business License" according to the law;
(3) the enterprise has been internally assessed, basically in line with the "Code for the Quality Management of Pharmaceutical Business" and its implementation rules of the conditions and requirements;
(4) In the 12 months prior to the application for certification, the enterprise did not have the problem of distribution of counterfeit and shoddy medicines caused by irregularities in operation (based on the date of administrative penalties imposed by the food and drug supervision and management department, the same hereinafter).
In summary, GSP refers to the quality management standard for pharmaceuticals, medical devices and other medical and health products. Different countries and regions may have different requirements for GSP certification, which need to be prepared according to the specific local requirements. If you need to apply for GSP certification, it is recommended that you consult a professional GSP certification organization or lawyer to better understand the specific requirements and procedures.
Legal basis:
Regulations for the Implementation of the Drug Administration Law of the People's Republic of China
Article 13
The drug supervision and management departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government and the municipal drug supervision and management agencies of the districts are responsible for the organization of the certification of the drug business enterprises. Drug companies should be in accordance with the State Council drug supervision and management department of the implementation measures and implementation steps, through the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management departments or municipal drug supervision and management agencies organized by the "Drug Certification Practice," the certification, to obtain the certificate of authentication. "Drug quality management standard" certificate of authentication format by the State Council Drug Administration unified regulations.
New drug wholesalers and drug retailers should obtain the "drug license" within 30 days from the date of issue of the "drug license" to the drug supervision and management department or drug supervision and management agency to apply for "Drug Quality Management Practice" certification. Accept the application of drug supervision and management departments or drug supervision and management agencies shall receive the application within three months from the date of application, in accordance with the provisions of the State Council drug supervision and management departments, organizations applying for certification of pharmaceutical wholesale enterprises or drug retailers are in line with the "Drug Certification Practice" certification; certification of qualified, certificates of authentication are issued.