What is EU GMP certification? EU GMP certification review

background

The European Union (EU) is one of the world's largest and most important international pharmaceutical markets. Since the results of "GMP certification/inspection" are mutually recognized/shared among nearly 30 EU member states, and the inspection results are also shared with the United States, Japan, Australia and Canada, the EU GMP certification/inspection has an increasingly greater impact on the world.

How to obtain EU GMP certificate

The main procedures for applying for official inspection are:

1. Become a commissioned processor for EU pharmaceutical companies

2. Apply for drug marketing authorization in the EU

3. Export products to the EU through EU importers

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. Applying for EU GMP certification must have a procedure to "trigger".

1. For drug preparation manufacturers, the “start-up” procedures for GMP certification inspection mainly include:

1. EU Marketing Authorization Application (MAA);

2. Import medicines into the EU through EU importers;

3. Accept “contract/custom production” from EU pharmaceutical companies;

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

(II) For API manufacturers, the “start-up” procedure mainly includes:

1. Application for "Certificate of Suitability to the European Pharmacopoeia (CEP/COS)";

2. Become a supplier of raw materials for drug preparations marketed in the EU;

That is to say, in order to obtain GMP certification inspection from the EU or its member states, Chinese companies must choose at least one of the above procedures to achieve it.

Chinese pharmaceutical manufacturers apply for European GMP certification through one of the above-mentioned "start-up" procedures, but most of the above-mentioned procedures involve European drug "registration". Companies must not only have a research and development foundation, but also a desire to register, and must have a large investment of funds and time.

So, if Chinese pharmaceutical manufacturers only want to obtain EU GMP certification, are there other convenient ways to achieve it? The answer is yes.

3. The certification process includes:

1. On-site inspection to understand the current situation

1. Understand the motivation, goals, policies, plans and requirements of the company regarding EU GMP certification;

2. Understand the current status of the company's GMP "software and hardware" and its compliance with EU GMP;

3. Make an objective assessment and give an assessment conclusion based on the on-site inspection;

4. Based on the actual situation of the enterprise, put forward overall arrangement opinions, discuss and determine the policies and strategies for the project.

2. Application and “Start-up” Inspection

1. Provide guidance for selecting suitable varieties;

2. Select appropriate EU partners and applicants;

3. Choose the appropriate inspection authority. The candidate countries include: Netherlands, Germany, France and Spain;

4. Assist the applicant to submit an application to the inspection authority and “start” the inspection;

5. Act as a liaison between the inspection authorities and Chinese pharmaceutical companies;

6. Coordinate and arrange the implementation of inspection work;

7. Assist in paying fees to the inspection authorities;

8. Provide guidance for on-site inspections;

9. Follow-up after inspection and application for certification documents.

3. On-site inspection

Standards and goals:

Based on the submitted application documents, relevant requirements and guidelines of EU GMP regulations, we guide and lead enterprises to rectify and improve the GMP "soft" and "hard" parts of the production site, help enterprises to fully prepare for the GMP "on-site compliance inspection" and ultimately pass the on-site inspection.

Job Description:

1. Guide enterprises to coordinate the organization and arrangement of GMP on-site inspections.

2. Based on the European GMP regulations and guidelines, we help enterprises to fully prepare for the GMP compliance inspection at the production site. We conduct a comprehensive on-site audit of the factory, discuss and determine the GMP compliance policy, overall arrangement, work task list and responsibilities of both parties. Including but not limited to:

2.1 European GMP training:

2.1.1. Interpretation and practical application of the provisions of EU or member states’ GMP;

2.1.2 Comparison between EU or member states’ GMP and China’s GMP;

2.1.3. The use and implementation of EU or member state GMP provisions in compliance inspections and inspection focus points;

2.1.4、Verification and key verification implementation guidance;

2.1.5. Other special training as required.

2.2. Appropriate rounds of "software" and "hardware" audits and rectifications, including:

2.2.1. Confirmation of the compliance of the environment, plant facilities and equipment, and renovation or new construction (including confirmation of the GMP compliance of the plant process layout);

2.2.2. Conformity evaluation of GMP document system, guidance and template provision for the preparation of important management procedures and operating procedures;

2.2.3. Guide the formulation of the validation master plan and key validation plans, including production process validation, analytical method validation, computer system validation, key equipment validation, important cleaning validation and sterilization procedure validation;

2.2.4. Guide the implementation of various verifications, and review and standardize verification reports.

3. Provide joint "simulated pre-inspection" of enterprises by experts, consultants and technicians;

4. Prepare the factory master file (SMF) required for on-site inspection;

5. Provide on-site technical and technical translation support when EU or member state officials conduct on-site GMP compliance inspections of production facilities;

6. Guide and assist enterprises to carry out correction and prevention (CAPA) of inspection deficiencies and provide feedback to European inspection parties.

Certification time

1. Customer intention confirmation and contract signing: 1-2 months;

2. Selection of EU partners and applicants: January-February;

3. Project planning and application: 1-3 months;

4. GMP compliance preparation: 3-6 months;

5. Official inspection confirmation: 3-6 months;

6. Inspection implementation and execution: 1-3 months;

7. Approval and certificate application: 1-3 months.

Most of the above activities are carried out simultaneously or in parallel, and the total time is about 8-12 months.

Certificate validity period

The validity period varies in different countries, generally three years.

cost

1. Official fees: The fees vary in different countries, generally 20,000-30,000 Euros, plus travel, food and accommodation expenses.

2. Consulting service fees (including EU cooperating party and applicant fees): depends on the specific circumstances.

significance

1. Obtaining EU GMP certification is the basic condition for products to enter the EU market with a population of nearly 600 million;

2. It is a necessary condition for obtaining "Contract/Custom Manufacture" in EU countries and other countries;

3. It is a manifestation of international GMP management level;

4. It is an effective means to improve the GMP management level of enterprises;

5. It is a clear condition for obtaining China’s preferential policies.

References