A approval letter from FDA in the United States，Laculu Pharmaceutical Co., Ltd. After the first domestic GMP certificate was obtained by the European Union's Sterilizer Specification,，A sterile medicine in China to pass the FDA inspection and get a approval letter in China。

As early as June 2010，FDA in the United States has approved FDA senior inspectors with rich sterile drug inspection experience，The six major systems of the production of a sterile raw material for a sterile of Qilu Pharmaceuticals conducted a careful and detailed inspection。FDA Inspection Group's production quality management level of Qilu Pharmaceutical、Sterile guarantee level and learning team give high evaluation，And recommended FDA to approve。After passing the final review of the on -site inspection report，FDA issued a written approval letter on January 24 this year，Formally recognized Qilu Pharmaceutical Sterilizer Production Quality Management of Sterilizer Production Occasion for CGMP in the United States。

 

Through the FDA inspection of the United States has become the vital puppet brick in my country's pharmaceutical industry to participate in the world market competition。Before this，There is no sterile raw material production enterprise in my country to pass the US FDA inspection。This once again proves the comprehensive strength of Qilu Pharmaceutical，Stake Sports Bettingstake sports betting appMore epoch -making significance for the domestic pharmaceutical industry。

 

Significance 1: It is conducive to improving the overall level of quality management of the pharmaceutical industry

 

With the acceleration of my country's economy and world integration，Out of the country to become the ideal of many powerful companies in China。In the pharmaceutical industry，If you want to get higher with foreign companies in the international market，First of all, you must pass this level of quality certification。American FDA inspection is one of the more difficult and difficult inspections。Domestic Western Pharmaceutical APIs If you want to enter the US market legally，It must apply to the US FDA for GMP inspection。

 

American FDA stipulates that companies must first perform DMF (DRUG MASTER FILE) declaration，After the review is qualified，Enterprise will get a DMF registration number，After the FDA is still less than three years, it is more than three years and seven or eight years of on -site inspection。American FDA emphasizes dynamic management and inspection，The key inspection is whether the Q7A file of the raw medicine GMP is strictly followed in the production management of the enterprise。and even after such a long time inspection and passing，Can't worry about it。If the product enters the Western market, once the quality problem occurs，It will face the punishment of warning and stop importing。

 

All these regulations，All required companies to be produced in strict strictly in strict accordance with GMP。This fundamentally changed the consistent approach of temporary assault in the past to cope with the inspection，Forced enterprises to manage high standard quality management as normal，so as to improve product quality and reputation to international level。

 

To establish a high standard quality management system，Qilu Pharmaceutical has established and improved raw material supply、Storage、Production、Test、Products release to product sales、Market information feedback, a whole set of management systems，Procedural control of product quality，Each process control point is in effective supervision stake sports betting appand management。Allow the My stake betting appproduct quality assessment indicators to the economic responsibility system，Implement a one -vote veto system。Investment in the introduction of international leading testing equipment and testing technology。According to the requirements of international ICH，For the drug medicine、The extreme trace impurities in the preparation are more stringent qualitative、Quantitative analysis measurement and control，To ensure the quality of the product。Company's factory building、Equipment、Production auxiliary system, etc. In accordance with the highest international standard、Installation and verification，Key equipment is imported from world professional manufacturers，Multi -aspects of advantages provide guarantee to produce high -quality products。

 

Significance 2: With participation in international market game qualifications

 

Well -known，Due to the reduction of environmental pollution due to environmental pollution, the production of many raw medicines in the local area，To the original 5 major raw and pharmaceutical areas of the world -EU、North America、Japan、China、India，refresh the pattern of production national competition for the two major raw materials based on China and India。India has gone in front of my country in the past ten years，It enters the international occupation market，A major magic weapon is the US FDA approval letter。

 

At the same time，Due to the high authority of the FDA，So，Checking through FDA will get recognition from most Western countries，It is also equivalent to obtaining a pass to enter the international market。At present, when foreign companies in the international market are looking for domestic manufacturers, they often determine whether to check it through the FDA，Even if you get DMF or EVF registration number，You can also get active and advantages in negotiation and price。

 

China Pharmaceutical Industry has implemented GMP for about 20 years，But the Chinese raw material manufacturer that meets the US and Europe market only accounts for about 35%of the total，There are only a few sterile raw materials companies who have passed EDQM certification，stake sports betting appBefore that, there was My stake betting appno domestic sterile raw material company to obtain the US FDA approval letter。

 

Research on the status quo of the production and quality management of a number of domestic sterile drug drug production enterprises in China can be discovered，The biggest obstacle for domestic sterile & US drugs to enter the European and American markets，The overall design of the sterile craft plane、High standards for production software、Verify the comprehensiveness and scientificity of the implementation、There is a big gap between the sterile consciousness of production personnel and the United States and the United States。So，Domestic pharmaceutical companies must learn from the scientific management ideas of Europe and the United States and WHO，Learn international rules，Join PIC/S，By improving technical levels and reduce microorganisms、Gragments、Pollution of toxins in bacterial internal bacteria，Through new technology、Training and employees' aseptic consciousness guarantee product quality，Make quality control of the entire production process，All processes must be carried out strictly in accordance with the verified methods and procedures，Product release cannot be judged by the final test，Instead, the principle of the release of parameters。

 

Made in China must have qualifications to participate in international games，Must work on quality standards and certification documents，truly regulate sterile production and quality management。At present, a few domestic companies have begun to have useful attempts，and achieved gratifying progress。

 

Significance 3: Enhance the power of corporate stamina and enhance the right to speak

 

In the past, the chemical raw medicines of our country can only be exported according to the chemical intermediate。and South Korea、India and other countries with the advantages of the US FDA approval letter，Simple chemical modification or even simple packaging of imported raw materials，You can get several times or even ten times the profit。And my country is a profit that should be obtained because of no FDA approval letter。

 

In addition to economic benefits，Checking through My stake betting appthe US FDA will also greatly Stake Sports Bettingestablish its own brand，Overall to improve my country's status and image in international pharmaceutical companies，Enhance my country's right to speak in the international industry。

 

With excellent comprehensive strength，Qilu Pharmaceutical has become an enterprise inspected by the FDA zero defect、The first European Drug Quality Management Committee (EDQM) sterile product certification enterprise、British Food and Health Products Administration (MHRA) sterile product certification enterprise、Australian Medical Products Administration (TGA) sterile product certification enterprise、South Africa (MCC) certification enterprise，In addition, I also passed Japan、Certification from the national drug monitoring departments such as South Korea and the recognition of multiple foreign customers。It can be said，Qilu Pharmaceutical establishes confidence for domestic sterile pharmaceutical companies，I believe that more pharmaceutical companies will get the FDA approval letter，Go to a wider international "Blue Ocean"。