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Dynamic drug production management standard
Short for cGMP is Current English Good Manufacture Practices, namely dynamic pharmaceutical production management norms, also translated as Current pharmaceutical production management norms, it calls for the whole process of production and logistics must be verified, the leading international pharmaceutical production management standards. CGMP is the GMP standard implemented in countries such as the us and Europe, also known as the international GMP specification. The cGMP specification is not the same as the GMP specification currently being implemented in China. At present, the implementation of GMP in China is more emphasis on the renovation of hardware facilities, while cGMP certification focuses more on software construction and more requirements for software and personnel. This is because the quality of drug production is ultimately determined by the operation of the operator, so the role of personnel in cGMP management is more important than the plant equipment. Internationally, GMP has become the basic principle of drug production and quality management and is a systematic and scientific management system. Implementation of GMP, and not just through a test to prove that meet the quality requirements of the end product, but in the whole process of drug production the implementation of a comprehensive scientific management and strict quality monitoring to obtain expected. The implementation of GMP can prevent the contamination, miscible and wrong drugs in the production process. GMP is a comprehensive quality management system for drug production, which is the basic system of pharmaceutical enterprises that guarantee the quality of drugs.
GMP is compared to cGMP
The GMP specification, which is currently implemented in China, is a GMP specification formulated by WHO, which is applicable to developing countries, and focuses on the requirements of production hardware, such as production equipment, with low standards. And countries such as America, Europe and Japan executed GMP (CGMP), also called dynamic pharmaceutical production management norms, its center of gravity in the production of software, such as standard operating personnel actions and how to deal with the emergency of the production process, etc.
The current code of GMP certification from the United States compared with our country code of GMP certification directory, you can tell the difference between the two and in the emphasis of requirements (see article) : can be seen from the directory comparison, to the three elements in the process of drug production, hardware system, software system and personnel, the GMP than simple Chinese GMP, less chapters. However, there is a great difference in the intrinsic requirements of these three elements. In China, GMP requires more hardware, and American GMP has more requirements for software and personnel. This is because the quality of the drug's production is fundamentally based on the operator's operation, so the role of personnel in GMP management is more important than plant equipment.
Read through the GMP in China and the United States the specific content, can be found an interesting phenomenon: in Chinese GMP, qualification of personnel (degree) in detail, but the duties of the office staff seldom constraints; And in the United States GMP, qualification of personnel (training) rule is simple, clear responsibilities of personnel rules are strict and detailed, the responsibility system to a great extent to ensure the production quality of the drug.
Another difference that can be found from GMP comparison is the collection and inspection of samples, especially inspection. Chinese GMP regulations only necessary inspection procedures, and in the United States GMP, for all the testing steps and method of regulation is very detailed, utmost ground to avoid the drugs in each stage, especially in confusion and pollution of the API stage, from the source to improve the quality of medicines. Ultimately, CGMP is focused on high standards of production software. Therefore, it is more accurate to change production management concept rather than implement CGMP to improve production management.
The current GMP requirements in China are still in the "primary stage" and are only formally required. In order to get their products into the international market, Chinese enterprises must meet the international standards from production management to gain market recognition.
Although the government has not yet imposed a mandate to implement cGMP, this does not mean that China does not have the urgency to implement cGMP. On the contrary, the management of the whole production process by cGMP is an essential prerequisite for internationalization. The good news is that, at present, the pharmaceutical companies with forward-looking and forward-looking strategies have realized the long-term significance of this specification and put it into practice. Canada has a history of nearly 30 years since it was written in 1975 and is one of the first countries to implement GMP.
Internationally accepted cGMP, both America and Europe at present, the production site of cGMP compliance checks pursued international coordination meetings (ICH) formulated by the API unification cGMP norms, also known as ICH Q7A. The specification originated from the ICH for API in Geneva, Switzerland, September 1997. In March 1998, the United States food and drug administration led the drafting of the uniform "API cGMP". In the autumn of 1999, the European Union and the United States reached the agreement on the cGMP mutual recognition agreement. After the agreement entered into force, the two parties recognized each other's cGMP certification results in the trade process of the API. For API enterprises, the cGMP specification is actually the specific content of ICH Q7A.
The so-called dynamic drug production management standard is to emphasize the field management (Current). When we are conducting cGMP training, we find that the head of the quality department of many enterprises is naive about the understanding of cGMP. When we demonstrated the cGMP site worker training content, we heard some people say, "well, it's just that. Yes, on the surface, the content of the cGMP especially in the field work part of the specification is not profound knowledge, but once the cGMP standard implementation in the real work process and details, you will find execution is not that simple. The main purpose of cGMP is to ensure stable product quality, and the quality of drugs is the core of cGMP, and the process of achieving this goal (or understanding as the site) is the most important.
For example, a European pharmaceutical company would submit a certified product to the us FDA if it was to break into the us market with a promising raw material for market development. Before, in the process of materials synthesis reaction tank, an accuracy of two thermometer deviation operator although processed and ask for instructions, but no detailed records on the production batch record. After the production of the product, the quality inspector only checked the known impurities when doing the chromatographic analysis and did not find the problem, so the quality inspection report was issued. FDA officials found when checking the precision is not in conformity with the requirements of the thermometer, but didn't find the corresponding record in production batch records, when checking the quality inspection report found no time for chromatographic analysis according to the requirements of regulations. All of these violations of cGMP cannot escape the scrutiny of the censors, and the drug ultimately failed to enter the U.S. market. The FDA decided that it did not implement the cGMP rules, which would harm the health of American consumers.
If, according to the requirements of cGMP in accuracy deviation should be arranged for further investigation, including the precision of temperature deviation may occur after the results of the inspection, at the same time should also place of deviation process description may be recorded. All inspections of drugs are only for known impurities and tests of known adverse substances, which cannot be fully examined by existing methods for unknown harmful ingredients or components.
In evaluating the quality of a drug, we often determine whether the drug is qualified or not, or based on the product's effect and appearance. In cGMP, however, the concept of quality is a code of behavior throughout the production process. A fully qualified quality drugs is not in conformity with the cGMP requirements, because it is the process of there appears the possibility of deviation, if not in a whole process to have the strict regulations, potential danger is cannot be found by the quality report. That's what I said earlier, why cGMP isn't that easy to execute.
It should be said that the improvement of GMP is relatively smooth. Then, if the cGMP problem is implemented again, the most difficult:
If implemented (cGMP), there will be problems. "The details" and "the authenticity of the process" should be the two most difficult aspects of our implementation of cGMP. China's current GMP specification is developed by the world health organization for developing countries. According to the hardware, Chinese enterprises can only pass the requirements of the hardware. However, cGMP emphasizes the authenticity of the process and the daily execution of the certification. To implement a high standard, perfect GMP, the real challenge lies not in the authentication, but in the daily control after certification. The FDA's on-site inspections are "critical" to detail and to the implementation process, as they follow the principle of ensuring that the patient's health is not compromised by potential dangers.
The majority of enterprises have a bias towards the substantive understanding of cGMP. We need a certain amount of time to inculcate the core thoughts of cGMP, which will also be the key to our successful implementation of cGMP.
Specifically, to reach this norm, where we are now:
In fact, the gap, mainly is the adjustment and adaptation of the concept. The purpose of cGMP is to make those problematic drugs known before they enter the market. It, wasn't damaged the health of consumers is lucky, but from the point of view of drug makers, the result is, unfortunately, because of products in production is not in conformity with the cGMP norms, enable manufacturers suffered huge economic losses. It seems that the cost of implementing cGMP is that Chinese pharmaceutical companies need a process and a period of time to change their mindset. On technical renovation, the hardware upgrade of Chinese enterprises to invest manpower and material resources and money, but they don't have the heart to see to produce qualified drugs because the process is not standard and has been in limbo, such losses are the manufacturer can't accept it. In fact, it's time to redefine the concept of "qualified". Implementing cGMP is an opportunity.
Now, what are the conditions of the API companies that we are using through the FDA's cGMP?
Domestic now learn cGMP's enthusiasm is high, both the American FDA official and domestic academic institutions, consultancy, training, also including the applicants of this meeting is an endless stream. According to my understanding, the meeting (" the second China international pharmaceutical BBS global pharmaceuticals procurement and outsourcing conference "), the representatives of a wish is to learn a foreign enterprise is how to implement cGMP, how to understand the FDA on drug production quality requirements, if to foreign procurement requirements of their cooperation, and a series of specific issues.
As of December 31, 2005, Chinese pharmaceutical companies reached 259 products through the us FDAcGMP specification, involving more than 130 enterprises. Such a result should be said to be welcome, indicating that our pharmaceutical enterprises in the quality of medicines has been gradually recognized internationally. The road is extending under our feet. Every step forward is a step closer to the truth. As long as we persist in pursuing advanced steps, we believe that the path of cGMP will not be far away. The CGMP certification has won the trust and affection of Korean women, and the perfect indented to repair the traces of the female years and rediscover the face of female youth. Natural safety and no stimulus come from strict CGMP detection.