Ⅰ、the background and meaning
The European Union (EU) is one of the world's largest and most important international markets for pharmaceuticals. As the results of “GMP Inspection” between the 30 member states of the European Union are mutually recognized/shared, and the results of inspections are shared with the United States, Japan, Australia and Canada, this makes the EU GMP certification/inspection global. The impact within the scope is growing.
In recent years, more and more Chinese pharmaceutical companies have begun to apply for and obtain EU GMP certification. The main reasons and significance include:
1. Obtaining EU GMP certification is the basic condition for products to enter the EU's nearly 600 million population market;
2. It is a necessary condition for obtaining “Contract/Custom Manufacture” in EU countries and other countries;
3. It is an embodiment of the international GMP management level;
4. It is an effective means to improve the management level of GMP in enterprises;
5. It is a clear condition for obtaining China's preferential policies.
Ⅱ、the certification process
In principle, European GMP certification is related to “pharmaceutical listing”. 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 “Trigger”.
(1) For pharmaceutical manufacturers, the “start-up” procedures for GMP certification inspection mainly include:
1. EU “Pharmaceutical Marketing License Application (MAA)”;
2. Importing drugs into the EU through EU importers;
3. Accept “contract/customized production” of EU pharmaceutical companies;
4. Become an overseas production plant of the European pharmaceutical company.
(2) For raw material pharmaceutical manufacturers, the “start-up” procedures mainly include:
1. Application for the European Pharmacopoeia Certificate of Applicability (CEP/COS);
2. Become a raw material supplier of pharmaceutical preparations listed in the EU;
In other words, in order to obtain the GMP certification inspection of the EU or its member states, Chinese companies must at least choose one of the above procedures to achieve.
We have the ability to help Chinese pharmaceutical manufacturers apply for European GMP certification through one of the above “start-up” procedures through our services, but most of the above procedures involve “registration” of European medicines. Enterprises must not only have a research and development foundation, but also have a desire to register, and It is necessary to have greater capital and time investment.
Then, if Chinese pharmaceutical manufacturers only want to obtain EU GMP certification, can there be other convenient ways to achieve this? The answer is yes.
Based on years of international certification service practice, with the guidance and cooperation of EU professional partners, we can help Chinese companies that only want to carry out European GMP certification to apply for GMP certification. The services we can provide include:
(1) On-site inspection to understand the status quo
1Understand the motivations, goals, policies, plans and requirements of the company regarding the EU GMP certification work;
2. Understand the status of "software and hardware" of enterprise GMP and the compliance with EU GMP;
3. Based on the site visit, make an objective assessment and give an assessment conclusion;
4. In combination with the actual situation of the enterprise, put forward general arrangements and discuss the policies and strategies for determining the project.
(2) Application and "start" inspection
1. Guide the selection of suitable varieties;
2. Select the appropriate EU partner and applicant;
3. Choose the appropriate inspection authority, including: the Netherlands, Germany, France and Spain;
4. Cooperate with the applicant to submit an application and “start” inspection to the inspection authority;
5. Acting as an associate between the inspection authority and the Chinese pharmaceutical company;
6. Coordinate and arrange the implementation of inspections;
7. Assist in the payment of fees to the inspection authority;
8. Guide to accept on-site inspections;
9. Application for follow-up and certification documents after inspection.
(3) On-site inspection
Standards and objectives:
Guided by and submitted to the company's application documents and relevant requirements and guidelines of the EU GMP regulations, the company will guide and lead the company to carry out rectification and improvement of GMP “soft” and “hard” parts at the production site to help enterprises fully carry out GMP “site compliance inspection”. Preparations are completed and finally passed the on-site inspection.
1. Instruct enterprises to coordinate the organization and arrangement of GMP on-site inspections.
2. Using European GMP regulations and guidelines as standards to help companies fully prepare for the GMP compliance inspection at the production site. Conduct a comprehensive on-site audit of the factory to discuss the guidelines, policies, overall arrangements, work tasks, 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 the EU or Member State GMP;
2.1.2. Comparison of EU or Member State GMP with Chinese GMP;
2.1.3. The use and manifestation of the GMP provisions of the EU or Member States in the compliance check and inspection of concerns;
2.1.4. Implementation and verification of key verification implementation guidelines;
2.1.5. Other required special training.
2.2. Appropriate rounds of “software” and “hardware” audits and rectifications, including:
2.2.1. Confirmation of conformity of environment, plant facilities and equipment, transformation or new construction (including confirmation of GMP conformity of plant process layout);
2.2.2. Compliance assessment of the GMP file system, preparation of guidelines and templates for important management procedures and operational procedures;
2.2.3. Guide the development of a master plan to guide the development of key verification protocols, including production process validation, analytical method validation, computer system validation, critical equipment validation, critical cleaning validation, and sterilization protocol validation;
2.2.4. Guide the implementation of various verifications, review and standardize the verification report.
3. Provide joint “simulation pre-inspection” to the enterprise by experts, consultants and technicians;
4. Produce the factory master file (SMF) necessary for on-site inspection;
5. Provide on-site technical and technical translation support when the EU or member state officials conduct on-site GMP compliance inspections of production facilities;
6. Guide and assist companies to correct and prevent inspection defects (CAPA) and give back to European inspectors.
(4) Time, cost and certificate validity
1) Confirmation and signing of customer intent: 1-2 months;
2) Selection of EU partners and applicants: January-February;
3) Project plan and application for 1-3 months;
4) GMP is in compliance with preparation; 3-6 months;
5) Official inspection confirmed: 3-6 months;
6) Inspection implementation and implementation: 1-3 months;
7) Approval and certificate application: 1-3 months.
Most of the above activities are carried out simultaneously or at the same time. The total time is about 8-12 months.
1) Official fees: different countries have different fees, generally 20,000-30,000 euros, plus travel and accommodation.
2) Consulting service fee (including EU partner and applicant fee): depending on the situation.
3. Certificate validity
Different countries have different validity periods, usually three years.
1. Long-term rich European API registration and GMP compliance inspection experience;
2. Long-term experience in Chinese preparation, especially import registration;
3. Established a working team with international preparation registration and rich GMP experience;
4. Standard professional workflows and working standards that have been formed;
5. Years of European registration and GMP compliance with regulations and technical requirements for special research and close tracking;
6. The ongoing European registration of injection needles, EPO, vaccines, etc., and GMP compliance with project accumulation experience;
7. Support from professional international consultants and European consultants.