1. EU GMP Certification

EU GMP CertificationIt is a mandatory manufacturing standard for drugs and medical devices sold on the market of EU member countries. The European Union (EU) is one of the world's largest and most important international mainstream markets for pharmaceuticals. Since the GMP certification and inspection results of nearly 30 EU member states are mutually recognized, the EU and the United States, Japan, Australia and other countries have gradually begun to recognize each other's GMP certification.

After obtaining the EU GMP certification, the product can enter the large market of nearly 0.6 billion people in the EU. At the same time, it can also improve the management level of enterprises and obtain more domestic preferential policies.

2. how to pass the EU GMP certification

Due to the implementation of China's new version of GMP (version 2010), the hardware equipment and facilities of Chinese pharmaceutical companies have gradually been in line with international equipment and facilities. Companies only need to transform on the existing basis, and it will be close to the international market. far away.

The main procedures for applying for an official inspection are:

1, to become the EU pharmaceutical companies commissioned processors

2. Apply for drug marketing authorization in the EU

3, through the EU importers to export products to the EU

Certification Procedure

In principle, European GMP certification is related to "drug marketing". The EU or its member states do not have an independent GMP certification/inspection procedure. To apply for EU GMP certification, there must be a procedure to "start (Trigger)".

(I) for pharmaceutical manufacturers, GMP certification inspection "start-up" procedures are:

1, the European Union "Drug Marketing Authorisation Application (MAA)";

Importing medicines into the EU through EU importers;

3, accept the EU pharmaceutical company "contract/custom production";

4. Become an overseas production plant for EU pharmaceutical companies.

(II) for raw material drug manufacturers, the "start-up" procedure mainly includes:

1, "European Pharmacopoeia Applicability Certificate (CEP/COS)" application;

2. Become a supplier of raw materials for pharmaceutical preparations listed in the EU;

3. EU GMP Certification Services

DST DST has been engaged in GMP certification consulting and counseling in Europe and the United States for many years, helping European and American pharmaceutical companies and domestic pharmaceutical companies to pass the EU GMP certification inspection for many times. To help more pharmaceutical companies go international, the following is our service

Process:

On-site Audit and Differentiation Analysis of (I) Enterprises

1. Investigate the current GMP level implementation status of pharmaceutical companies, audit the factory, and confirm the gap with the EU GMP level;

2. According to the on-site audit, formulate the audit report;

3. Formulate corresponding project rectification suggestions according to the audit report;

4. Communicate with customers to form the final project construction strategy;

5. Combined with the actual situation of the enterprise, put forward the overall opinion, discuss and determine the policies and strategies for the project.

Technology Transfer of (II) Products and EU GMP Certification

1. Assist companies to select suitable products and identify countries that require GMP certification;

2. Assist enterprises to sign product transfer or commissioned production agreements;

3. Cooperate with pharmaceutical companies to complete product registration;

4. Help enterprises to complete product technology transfer;

5. Assist enterprises to complete the construction of GMP system and verification system;

6.GMP approval data collation and submission;

7. Provide experts, consultants and technical personnel to conduct joint "simulation inspection" of the enterprise ";

8. Provide on-site technical and technical translation support during on-site GMP compliance inspections of production facilities by EU or Member State officials;

9. Guide and assist enterprises in the correction and prevention of inspection defects (CAPA) and feedback to European inspectors.

10. EU listing approval and commercial production of enterprise products.

5. EU GMP certification case

Durst DST team has implemented dozens of European and American GMP projects, and has been recognized by customers, involving EU GMP solid products, non-final sterilization injection products, final sterilization injection products, raw materials and other different types of products.

If you need FDA certification related services, please contact 18826007039/13326993435 (WeChat with the same number)