KGMP/CGMP > BOCLEAN


Kor  l   Eng  l   Jap
Business Area
BOCLEAN Co., Ltd. is a company specializing in clean room facilities and refrigeration facilities.

KGMP/CGMP

GMP What's this?
GMP stands for Good Manufacturing Practice is referred to as the 'Good Manufacturing Practices'.

Word that stands for a minimum of facilities to produce products that are normally excellent standards in our country in the field of pharmaceuticals and cosmetics, food, health supplements GMP is applied.

Title21 CFR, Part 110 of the United States federal law (Code of Federal Regulation) technology is titled Good Manufacturing Practice and '' Good Food Manufacturing Practices for food manufacturing, packaging, storage, and. Enactment conducted by various GMP for each industry sector GMP, biologicals, such as GMP (Bio GMP), raw medicine products from GMP (BGMP), etc., depending on the needs of the international exchange GMP excellent manufacturing management system is accelerating.
Necessity of GMP
CGMP What's this?
Excellent cosmetic manufacturing and quality control standards, Cosmetic Good Manufacturing Practice (CGMP) for the first time codified in 1990 the Department of Social and Health Services Standard Operating Procedures (575). Then, in 1992 has been amended by specifying that eligible businesses, however, and Cosmetic Act (Act 6025, 99,9.7) enacted. Horror, from July 1, 2000, CGMP performed by the Food and Drug Administration (KFDA 2000-59, 2000,12,1) as amended until now. Cosmetic enactment of the cosmetics industry the opportunity to develop state-of-the-art technology, the accumulation of industrial achievement is prepared. A series of such courses in the cosmetics industry and the ongoing efforts of the era by calling. I would say that laid a solid foundation for the development of the cosmetics industry. CGMP system that can adapt to the internationalization front is due to be revised. Revised in the light of these new aspects of CGMP (KFDA Notification No. 2000-59) was revised look at the front of the system to adapt to the internationalization is a fact. Organize them what's important by EU-CGMP regulations on the manufacture of water management and its contents ISO9000 series in quality management systems and quality assurance regulations, then step forward was the introduction of complementary.
Is important in terms of the quality of water and the contents and manufacturing to strengthen regulations, and enhance the standards of quality management system and pumjik warranty. By the fact that the integrated regulation of unreasonable standards workshop, Workshop of the war, General studio, charging workroom, storage, etc., as well as detailed rules had to avoid duplication, and to add a definition of the term complement CGMP designation and supervision by enema performed for the Cosmetic Industry Association.
The basic of Revision CGMP
Previous CGMP (see Resources)
Cosmetic Act enacted Law No. 6025 (in the background) 1. CGMP
2. ISO 9000series
3. EU-CGMP
Revised CGMP (KFDA 2000 - No. 59, 12/01/2000)
Overview of the CGMP
  1. Minimizing the Contrived mistake
  2. Prevent degradation of the quality due to microbial contamination and cross-contamination.
  3. Establishment of a quality management system are the three major components of the CGMP excellent cosmetic manufacturing, improved quality supply to consumers
  4. Trusted that nothing can supply the products produced are basic elements. Ensure the quality to adapt to the era of liberalization
  5. Distribution for the production of cosmetics, as amended by the international CGMP