China GMP Certification
Release time:
2024-10-25
GMP According to Decree No. 79 of 2011 signed by the Minister of Health of the People's Republic of China, the "Good Manufacturing Practice for Drugs (Revised in 2010)" (hereinafter referred to as the new version of GMP) will come into force on March 1, 2011. The new version of GMP and the EU's GMP system construction and requirements are getting closer and closer, CFDA's management characteristics of the pharmaceutical industry has gradually entered a more standardized trend, therefore, it also requires enterprises to improve the overall GMP management level of enterprises through continuous learning of new technology management.
1. China 2010 version GMP certification
GMP According to Decree No. 79 of 2011 signed by the Minister of Health of the People's Republic of China, the "Good Manufacturing Practice for Drugs (Revised in 2010)" (hereinafter referred to as the new version of GMP) will come into force on March 1, 2011. The new version of GMP and the EU's GMP system construction and requirements are getting closer and closer, CFDA's management characteristics of the pharmaceutical industry has gradually entered a more standardized trend, therefore, it also requires enterprises to improve the overall GMP management level of enterprises through continuous learning of new technology management.
2. implementation of new GMP strategy
1. Enterprises should build plant facilities and hardware systems in accordance with international standards through the implementation process of the new version of GMP, strengthen their international competitiveness, and obtain vast opportunities for foreign standardized markets.
2. Through the construction of GMP system, GMP software will also be improved. Such as improving the quality of staff, standardize the verification system.
The construction of the new plant should consider the choice of international development direction of the design, Europe and the United States high standard enterprises, after the completion of the factory construction, usually the enterprise's pharmaceutical plant production line can be used normally for 15 to 20 years without the need for major transformation. However, Chinese pharmaceutical companies often need to make major modifications to their factories and public facilities every 5 years to meet the requirements of GMP. Often this transformation to the enterprise caused a great cost. Therefore, the choice of a good design, construction, in the long run, can bring good economic and legal benefits to the enterprise.
3. Durst service content:
In accordance with the Chinese 2010 version of the drug GMP standards for raw materials pharmaceutical enterprises, preparation enterprises (including non-sterile products and sterile products) for GMP certification guidance, the main work is as follows:
1. Enterprise diagnosis
Conduct pre-audit and propose improvement and coaching plans in accordance with China 2010 GMP standards and customer requirements.
2, hardware design and construction transformation phase consulting and guidance
Design drawing review, equipment selection and construction installation and acceptance guidance.
3. Software coaching improvement and completion of process validation and training
Complete the basic verification and process verification, complete the software system improvement and training.
4. GMP certification stage counseling
Certification application, preparation for review, participation in on-site audit and follow-up rectification, follow-up certificate/GMP compliance report issuance.
Service Case
NMPA projects involving solid preparations;
Injection NMPA Project;
NMPA project for radiopharmaceuticals:
API NMPA project;
Traditional Chinese Medicine NMPA Project:
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Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
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