Difference between China GMP and International GMP

Translate by Hadi Jafar
One: 　　Requests of GMP
The GMP standard which our country carries out at present is established by WHO being suitable in the developing countries, stresses to produce the hardware for instance production equipment’s request, and its standard is low. However, national execution carried by such as US, Europe and Japan is International GMP (i.e. Current Good Manufacture Practice, CGMP for short), which also called the dynamic drugs production management standard, does its center of gravity in the production software aspect, for instance operators’ movement and process in the production process the thunderbolt. We can make out the difference and the request emphasis point by comparing the table of contents of the American present GMP authentication standard and our country’s GMP authentication standard.

American GMP table of contents:
A. General rule
B. Organization and Personnel
C. Workshop and Facility
D. Equipment
E. Ingredient, Drugs vessel and Seal control
F. Production and processing control
G. Packing and label control
H. Storage and Sale
I. Laboratory control
J. Record and Report
K. Returns drugs and Recovery
China’s GMP table of contents:
Chapter 1. General rule
Chapter 2. Organization and Personnel
Chapter 3. Workshop and facility
Chapter 4. Equipment
Chapter 5. Material
Chapter 6. Sanitation
Chapter 7. Confirmation
Chapter 8. Document
Chapter 9. Production management
Chapter 10. Quality control
Chapter 11. Product sale and reclamation
Chapter 12. Complaints and Untoward effect report
Chapter 13. Self-checking
Chapter 14. Supplementary

We can make out from the table of contents above that of the production of drugs the course of three elements - hardware systems, software systems and personnel. The US CGMP is simple comparing China GMP, less chapters. However, it has great difference between the three elements of the inherent requirements. China’s GMP requires on the hardware, while the USA CGMP on the software and more staff. This is because the quality of medicines fundamentally depends on the manipulation of operators. So operators make much the quality of medicines fundamentally depends on the manipulation of operators. So operators make much more effect in CGMP management than workshop and facility.

In the international arena, GMB has become a basic norm for drug production and quality control, and it is a series of systemic and scientific manage system. Implementation of GMP, not only through the ultimate test to prove that products meet quality requirements, but in the whole process of drug production in the full implementation of scientific management and strict quality control to be expected. GMP implementation of the production process can prevent the pollution of drugs, mixed drugs and the wrong medicine. GMP pharmaceutical production is a comprehensive quality management system. In contemporary times, as the increasingly fierce competition, product quality abide by the various pharmaceutical companies, has so painstakingly built up magic weapon for the competition. The GMP provides a guarantee of the quality of the basic system of pharmaceutical companies.
Two: 　　History of GMP
GMP is the English name Good Manufacturing Practices for Drugs or Good Practice in the Manufacturing and Quality Control of Drugs acronym. GMP can be literally translated as "good manufacturing practice", of course here we mainly refer to the drugs production. Food, cosmetics, etc. should also refer to GMP to produce, that is, "for Food," "for Cosmetic." As GMP has been like TV and other customary abbreviations Loanwords application, in addition to official documents, it has been common, and it is to be international common vocabulary. 

China’s GMP called "pharmaceutical production and quality control." State Drug Administration on June 18, 1999 promulgated the "pharmaceutical production and quality control (revised 1998)." GMP is the scientific and technological progress of human society and the necessity of the development of management science product, and it is to assure the quality of pharmaceutical production and the needs of management. GMP originated from abroad, and it came into being with a major drug disaster.
Looking back at the 20th century, the major inventions of medicine, such as aspirin, sulfonamide, penicillin, insulin, contraceptives and so on, is of epoch-making significance, and these drugs have played a major role in human health. But people in drug awareness of Adverse Reactions also paid a heavy price.
Sulfonamide (SN) is the first of a modern therapy compounds. Gerhard, who was a biologists discovered its antibacterial properties in 1935. Prontosil as the precursors of sulfonamide had applied to clinic for more than 10 years. In 1937, a pharmacist in Tennessee in the United States put up sulfa as a result of 300 people with acute renal failure, of which 107 people death. The reason of sweeteners diethylene glycol in the body of oxalic acid poisoning is caused by, so the United States, in 1938, revised the Federal Food, Drug, and Cosmetic Act. This method was again revised in 1962, that is it took place the biggest drug disaster - "thalidomide" incident in the 20th century in the world.

In the late 50s of 20th century original German Gelunnansu pharmaceutical production made a claim for curing pregnancy reaction sedative drug which called Thalidomide (also known as thalidomide, of Thalidomide, peptide-piperidine microphone). This is a real 100% of teratogenic drugs. The sale of the drug after six years and had worked for the former Federal Republic of Germany, Australia, Canada, Japan, as well as Latin America, Africa, a total of 28 countries, found that more than 12,000 cases of fetal malformation (of which in Western Europe alone 6000~8,000 cases, about 1,000 cases of Japan) . Children without limbs, short limbs, limb there problems, such as heart malformations congenital anomaly, a seal limb malformations (phocornelia).

Now, there are thousands of people survive, and they have brought a great burden to the community. Another side effects of Thalidomide is it can cause Polyneuritis, about 1,300 cases. The drug caused disaster for the first is the "thalidomide" has not been strictly pre-clinical pharmacology experiments, and the second is Gelunnansu, the production of the drug laboratories had been received thalidomide toxic reaction more than 100 cases , but they had been hiding down. In 17 countries, a new form of thalidomide concealed down, continuing to cause harm. For example, Japan begun to discontinue thalidomide until 1963, and it got a great disaster. Film "Code of" is - a true portrayal of the victims. The disaster cause public outcry, and parents of children brought the accused to the court, known as the "20th century’s largest drug disaster." Exaggeration of the original manufacturers got publicity by the media criticism, and some government departments were compelled to strengthen the management of the listed drugs. This pharmaceutical company had to be closed because of the infamous thalidomide incident h.

A few countries survived in this disaster, such as the United States, France, Czech and Slovakia. The United States lessoned from the incident of sulfanilamide elixir in 1938 and did not approve the import "Thalidomide." At that time, the FDA (the Food and Drug Administration) officials in the review of the drug found it lack of clinical trial data and refused to import. So it avoided this disaster. Just because of private carry drugs from abroad, there were only nine cases of deformed babies. However, the serious consequences of this incident aroused concern in the United States, and aroused the public’s drug supervision and drug regulation’s general interest, which eventually led to the Congress of "food \ Drugs and Cosmetics Act" major changes. The amendment of
1962 markedly strengthened the Drugs Act, the following three specific areas:
(1) Require pharmaceutical companies to prove that drugs are not only effective, but also to prove that the drugs
are safe
(2) FDA requested pharmaceutical companies to report adverse reactions drugs.
(3) Require pharmaceutical companies to carry out execute the pharmaceutical production and quality control.

In accordance with the requirements of the amendment, the United States Congress enacted the world’s first GMP in 1963. GMP was initially written by six professor of US Temple University and developed by FDA officials repeatedly. In the United States it had indeed received results after several years of implementation of officials repeatedly. In the United States it had indeed received results after several years of implementation of GMP. 1967, World Health Organization (WHO) in its publication of the "International Pharmacopoeia" (1967 version) carried out in the appendix containing.1969, No. 22 session of the World Health Assembly, WHO recommended that its members use the system in pharmaceutical production to ensure that the drug quality and enter the Certification Scheme On the Quality Of Pharmaceutical Products Moving in International Commerce (visa system). Japan Pharmaceutical Industry Association raised its GMP in 1973. In 1974, the Japanese Government promulgated GMP, the implementation guidance. November 1975 WHO GMP formally announced. 1977, No. 28 session of the World Health Assembly, WHO Members were Stated once again to recommend GMP, and to determine the regulations for the WHO. GMP was contained in the "Official Records of the World Health
Organization," Article 226, Annex 12.WHO GMP system is the comprehensive quality management in pharmaceutical production and an important part to ensure the quality of medicines, and the error in the accident, mixing drugs, the possibility of various kinds of pollution to a minimum under the necessary conditions and the most reliable approach. The United
States again enacted in 1978, as amended GMP. Japan decided the implementation of GMP in 1980.

Since then, the United Kingdom, Japan and most European countries begun to have their information, awareness and drafting of the national GMP. European Commission also promulgated the EC GMP. Up to 1980 a total of 63 countries had enacted GMP. At present, more than 100 countries have implemented a GMP system. With the development progress of society, science and technology, all countries in the implementation of GMP constantly in the process of revising and perfecting them, and developed a variety of detailed rules and guidelines, such as the United Kingdom in 1985 published fourth edition of GMP Guide on the implementation of GMP specific provisions. Japan also constantly revised GMP, the detailed provisions of the articles, and according to GMP pharmaceutical companies to be self-inspection requirements detailed provisions .1988, the Government of Japan established GMP pharmaceutical raw materials, the implementation started in 1990.

WHO GMP was on its amendment in 1990, and the amendment again in 1992, including the following four aspects:
(1) Introduction, General and terminology introduced the production of GMP and the terminology used in
(2) Quality management purposes and basic elements in the pharmaceutical industry. This section includes QA, GMP, QC, environment and Sanitation , validation, customer complaints and product recovery, contract manufacturing and contract analysis, self-inspection and quality review, personnel, plant, equipment, materials and documentation for a total of 14 areas.
(3) The production and quality control, including production and quality control.
(4) Addition of the guiding principles, including GMP sterilization drugs and active pharmaceutical components (API).
Three: Category of GMP
(1) GMP can be divided into three categories from the scope of the existing:
① International GMP. For example, WHO GMP, the Nordic seven-nation free trade union PIC-GMP (PIC for the Pharmaceutical inspection Convention), the Association of Southeast Asian Nations and other GMP, etc.
② Promulgated by the State authority. Such as GMP made by the People’s Republic of China Ministry of Health and the State Pharmaceutical Supervision and Administration, the US FDA, the United Kingdom Department of Health and Social Insurance, the Japanese Ministry of Health and Welfare and other government.
③ GMP made by industrial organizations in the development. Such as Federation of the pharmaceutical industry of the United States developed, which standard not lower than the United States Government, China’s pharmaceutical industry to formulate guidelines for implementation of GMP, or even include pharmaceutical companies developed their own.
(2) It can be divided into two categories from the nature of the GMP system,:
① GMP will be provided as a code. For example, the United States GMP, Japan GMP and China GMP.
② GMP will be the requirement as proposed, some GMP played on the pharmaceutical production and quality management guidance, such as the United Nations WHO GMP.

In conclusion, pharmaceutical production management and quality management according to GMP requirements has become an irresistible trend. States GMP contents are basically the same, but also have their own characteristics. It can also develop large single infusion of GMP On the special varieties, like LVP-GMP (Large Volume Parenteral-GMP). Practice shows that the GMP is a well-established scientific and systematic management system for ensuring the quality of medicines play a positive role which has been generally recognized by the international community.

WHO "International Trade Drug Quality visa system" has been provided drugs exports of the plant must be conducted in accordance with the GMP production and accept the supervision and management department of import countries under its supervision of the provisions of GMP. Case, in accordance with the GMP requirements drugs production has been entered into drugs a prerequisite for the international market. GMP has become an international drug quality control and inspection basis. In recent years, some of China’s pharmaceutical enterprises, in order to enhance export competitiveness in the implementation of GMP on the basis of the beginning of the drug master file (DMF, Drug Master File, or a drug management file) the preparation work. DMF is to the European Union EU and the United States FDA for permission to enter the markets in Europe and the first steps to provide the necessary documents. DMF serve as a "pass" to the role. China also strictly on the foreign and joint ventures in China to manufacture drugs to registration, inspection approval procedures.