GMP Standard
Standard Interpretation
GMP standards are a set of mandatory standards applicable to the pharmaceutical, food and other industries. They require enterprises to meet the sanitary quality requirements in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control, etc. in accordance with relevant national laws and regulations, and form a set of operational operating specifications to help enterprises improve their sanitary environment, timely discover problems in the production process, and improve them. In short, GMP requires that production enterprises should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the quality of the final product (including food safety and hygiene) meets the requirements of regulations.
The content stipulated by GMP is the most basic condition that pharmaceutical processing enterprises must meet.
Good Manufacture Practice (GMP) is a regulation guiding pharmaceutical production and quality management. The World Health Organization officially announced the GMP standard in November 1975. The concept of drugs internationally includes veterinary drugs. Only a few countries such as China and Australia separate GMP for human drugs and GMP for veterinary drugs.
China GMP Development History
For human medicine, the Ministry of Health issued the Good Manufacturing Practice for Pharmaceuticals in 1988 in mainland China. After several revisions, the latest Good Manufacturing Practice for Pharmaceuticals (Revised in 2010) was reviewed and approved by the Ministry of Health on October 19, 2010. It is now issued and will be implemented from March 1, 2011.
GMP in China's veterinary drug industry began to be implemented in the late 1980s. In 1989, the Ministry of Agriculture of China issued the Good Manufacturing Practice for Veterinary Drugs (Trial) and in 1994, it issued the Implementation Rules for the Good Manufacturing Practice for Veterinary Drugs (Trial). From October 1, 1995, all qualified pharmaceutical production enterprises (workshops) and drug varieties can apply for pharmaceutical GMP certification. Enterprises (workshops) that have obtained pharmaceutical GMP certification will be given priority by the health administrative department when applying for the production of new drugs. As of June 30, 1998, the health administrative department will no longer accept new drug production applications from enterprises (workshops) that have not obtained pharmaceutical GMP certification.
On March 19, 2002, the Ministry of Agriculture revised and issued the new "Good Manufacturing Practice for Veterinary Drugs" (hereinafter referred to as "Veterinary GMP Practice"). On June 14 of the same year, Announcement No. 202 was issued, stipulating that the transition period for the implementation of the "Veterinary GMP Practice" would be from June 19, 2002 to December 31, 2005, and that it would be enforced from January 1, 2006.
China's drug regulatory authorities have vigorously strengthened the supervision and management of drug production, and the implementation of GMP certification has achieved phased results. All blood products, powder injections, large-volume injections, and small-volume injections manufacturers are in accordance with GMP standards. The country hopes to improve the overall level of drug production management through GMP certification and avoid low-level duplication. Companies that have passed GMP certification can inquire at the Drug Certification Management Center.
The clean workshops and pharmaceutical equipment provided by CELINE PHARMA fully meet the GMP standards. In addition, we can also provide products that meet local pharmaceutical standards according to customer requirements.