In the second year of production, namely1August 1988, Huarui successfully passed the GMP inspection of Swedish Ministry of Health, and1April 1998, the whole company passed the national GMP certification. However, Huarui did not stop there, but moved towards a higher goal: in June 2000, the second phase project (large infusion production line) with international advanced level passed the national GMP certification; In March of the same year, the second phase of the project and freeze-dried powder injection successfully passed the EU GMP certification, making Huarui the only pharmaceutical company in China that passed the EU GMP certification for large-capacity injection and freeze-dried powder injection, which also indicates that in the field of large-capacity injection and freeze-dried powder injection with the highest GMP requirements, Huarui's product quality and GMP management keep pace with the international advanced level; Huarui also dynamically followed the international advanced quality assurance concepts and technologies, introduced and promoted the latest GMP achievement "parameter release" to China, and obtained special approval from the State Food and Drug Administration in February 2005 to implement "parameter release" for all final sterilized products, becoming one of only two enterprises in China that were allowed to implement "parameter release".
Huarui passed the GMP inspection of domestic drug regulatory agencies in the past.
1998 1 month, becoming the first "large-capacity injection molding enterprise" in China.
1April, 1998, the whole factory obtained the "GMP certification of China".
June 5438 +2000 10, the second phase of the project was awarded the "GMP Certificate of China".
From June 5, 2003 to 10, the enteral nutrition emulsion obtained the GMP certificate of China.
In June, 2004, 165438+ 10, the tablets obtained the GMP Certificate of China.
In February, 2005, large-capacity injection, freeze-dried powder injection and small-capacity injection obtained the GMP Certificate of China (re-certification and inspection after 5 years of validity).
In February, 2005, the final sterilized product was approved by the US Food and Drug Administration to implement "parameter release".
Huarui has passed the GMP inspection of foreign drug regulatory agencies in the past.
1August, 988, the whole company passed the GMP inspection of the Swedish Ministry of Health.
199 1 year 1 month, the whole company passed the GMP inspection of the Swedish Ministry of Health again.
In March 2000, large-capacity injection and freeze-dried powder injection passed the GMP certification inspection of the European Union.
In March 2002, large-capacity injection and freeze-dried powder injection passed the GMP certification examination of the European Union.
In June, 2004, 165438+ 10, large-capacity injection and freeze-dried powder injection passed EU GMP certification. The workshop and process route are designed and built in full accordance with the GMP standards of WHO and EU, and the layout is scientific and reasonable. Introduce international advanced GMP management software from foreign joint ventures, and digest, absorb, modify and improve it dynamically through system verification and scientific dynamic monitoring to make it more scientific and applicable.
Complete sets of process equipment imported from Germany, the United States and other countries have strong quality reliability, good stability and high degree of automation, which provides a strong guarantee for ensuring product quality. If a unique sterilization system is introduced from Austria, the products will rotate continuously in the sterilizer, with good heat distribution and uniform heating, and there is no "cold spot" to ensure the consistent sterilization effect and stable quality of all products; The sterilizer uses water for injection as the heating and cooling medium of the product, which effectively avoids the "secondary pollution" of the product after sterilization.
Computer control system is introduced from Siemens in Germany to intelligently control the production process to ensure that all process parameters are strictly controlled within the set requirements, which is more efficient and stricter than manual control.
The production environment conforms to the static standards stipulated by GMP in China and the dynamic control standards of EU and US FDA. The air conditioning purification system with constant air volume and automatic frequency conversion control was introduced from Swedish TA company, and the microcomputer in the central control room carried out comprehensive real-time automatic control on the operation, monitoring and adjustment of the whole system.
According to the GMP standards of FDA and EU, the production process of freeze-dried powder injection is verified by aseptic filling test of culture medium, and the re-verification of filling test of culture medium is carried out at least twice a year. At present, the international standard of aseptic filling test of culture medium has not been introduced into GMP in China.
According to the GMP standards of FDA and EU, the integrity and compatibility of the container sealing system of the product are strictly verified to ensure the microbial quality and physical and chemical quality of the product during the whole validity period. At present, GMP in China has not issued relevant requirements for integrity verification of container sealing system.
According to the requirements of FDA and GMP, the microbial content of each batch of liquid medicine before sterilization or sterilization and filtration was monitored, which comprehensively reflected the comprehensive level of raw material quality, production environment, equipment pollution prevention and control, personnel operation and so on. At present, GMP in China has not introduced this requirement.
Equipped with special air separation and liquid nitrogen storage and distribution system, it can supply high-purity sterile nitrogen with purity of 99.999%, protect the whole process of drugs and technology, avoid product degradation and ensure the quality of drugs during production and storage. At present, other domestic enterprises can only buy commercially available nitrogen, and the purity can only reach 99.99%, which cannot be used in the whole production process. Introduce the international advanced API microbial identification system to identify the contaminated bacteria found in the environment, personnel, raw materials, process equipment and liquid medicine, and analyze and control the product quality. At present, except for a few foreign-funded enterprises that produce aseptic drugs, most pharmaceutical companies have not introduced this system, so it is difficult to scientifically judge the control quality of the production process.
Adopting strict medical bar code system, automatic labeling machine and label bar code machine imported from Italy can automatically identify, count and check labels, effectively preventing possible drug mixing, which has not been realized by other domestic pharmaceutical companies.
On the basis of "China Pharmacopoeia", strict microbial control standards have been added to all raw materials, and some raw materials have been controlled for related substances or volatile organic impurities to ensure their safety.
A new type of pure water system with pasteurization function was introduced from Elga company in Britain, and a multi-effect distiller and pure steam generator were introduced from Fi-Aqua company in Finland. The design and operation were carried out according to the relevant requirements of EU and FDA in the United States. The quality index of water for injection not only meets the requirements of China Pharmacopoeia, but also increases the monitoring of electrical conductivity, total organic carbon and total number of colonies according to the requirements of European and American Pharmacopoeia.
All products are subject to internal control quality standards higher than national standards, keeping pace with international standards, or adding new control items on the basis of national standards, or improving control indicators on the same control items.