GMP is a system to ensure products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. A directive circular issued by the Ministry of Health in Jul 95 marked the official launch of GMP certification in China. The China Certification Committee for Drugs (CCCD) was established in the same year. A subsidiary organization was also set up to manage the certification program.
Currently nine government agencies are the key agencies responsible for regulation. They are the State Food and Pharmaceutical Administration (SFDA), the State Development and Reform Committee, the Commerce Ministry, the State Traditional Chinese Medicine Administration, the Ministry of Labor and Social Security, the Ministry of Health, the State Population and Family Planning Committee, the Ministry of Science and Technology, and the State Quality and Technology Supervision Administration.
In addition, more than 10 industrial associations also regulate the industry.
TÜVs (German pronunciation: [?t?f]) (short for Technischer Überwachungs-Verein, Technical Inspection Association in English) are German organizations that work to validate the safety of products of all kinds to protect humans and the environment against hazards. As independent consultants, they examine plants, motor vehicles, energy installations, devices and products (e.g consumer goods) which require monitoring. The many subsidiaries of the TÜVs can also act as project developers for energy and traffic concepts, as problem solvers in environmental protection, and as certification bodies. Many of the TÜV organizations also provide certification for various international standards, such as ISO9001:2008 (quality management system) and ISO/TS16949 (automotive quality management system).
The Federal Communications Commission (FCC) is an independent agency of the United States government, created, directed, and empowered by Congressional statute (see 47 U.S.C. § 151 and 47 U.S.C. § 154), and with the majority of its commissioners appointed by the current President. The FCC works towards six goals in the areas of broadband, competition, the spectrum, the media, public safety and homeland security, and modernizing the FCC.[1]
The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.
The ISO 14000 is a standard for environmental management systems that is applicable to any business, regardless of size, location or income. The aim of the standard is to reduce the environmental footprint of a business and to decrease the pollution and waste a business produces. The most recent version of ISO 14001 was released in 2004 by the International Organization for Standardization (ISO) which has representation from committees all over the world. The ISO 14000 environmental management standards exist to help organizations minimize how their operations negatively affect the environment. In structure it is similar to ISO 9000 quality management and both can be implemented side by side. In order for an organization to be awarded an ISO 14001 certificate they must be externally audited by an audit body that has been accredited by an accreditation body. In the UK, this is UKAS. Certification auditors need to be accredited by the International Registrar of Certification Auditors. The certification body has to be accredited by the Registrar Accreditation Board in the USA, or the National Accreditation Board in Ireland.
* ISO 14001 Environmental management systems—Requirements with guidance for use
* ISO 14004 Environmental management systems—General guidelines on principles, systems and support techniques
* ISO 14015 Environmental assessment of sites and organizations
* ISO 14020 series (14020 to 14025) Environmental labels and declarations
* ISO 14031 Environmental performance evaluation—Guidelines
* ISO 14040 series (14040 to 14049), Life Cycle Assessment, LCA, discusses pre-production planning and environment goal setting.
* ISO 14050 terms and definitions.
* ISO 14062 discusses making improvements to environmental impact goals.
* ISO 14063 Environmental communication—Guidelines and examples
* ISO 19011 which specifies one audit protocol for both 14000 and 9000 series standards together. This replaces ISO 14011 meta-evaluation—how to tell if your intended regulatory tools worked. 19011 is now the only recommended way to determine this.
International (Canadian Standards Association), a member of the CSA Group, is a provider of product testing and certification services for electrical, mechanical, plumbing, gas and a variety of other products. Recognized in the U.S., Canada and around the world, CSA’s marks appear on billions of products worldwide.
CSA International certification marks indicate that a product, process or service has been tested to a Canadian or U.S. standard and it meets the requirements of an applicable CSA standard or another recognized document used as a basis for certification.
For consumers, CSA International certification marks are intended to provide increased assurance of quality and safety. For manufacturers, international recognition of the mark may help to ease their entry into North American markets. CSA International certification marks are accepted by many North American regulators and by a large number of North American retailers. Billions of products bearing CSA International certification marks are found on the shelves of well-known retail chains and sold by major product distributors.
CSA International tests products for the North American and International markets against applicable standards including those of the Canadian Standards Association (CSA), Underwriters Laboratories (UL), NSF National Sanitation Foundation (NSF), American National Standards Institute (ANSI) and other agencies.
LOHAS is an acronym for Lifestyles of Health and Sustainability, a market segment focused on health and fitness, the environment, personal development, sustainable living, and social justice.
KACST mean “Korea Academy of Commodity Science & Technology”, KYK machine was awarded as best products in Korea.
INNOBIZ mean “Innovation & Business”, This cert. would be given to the small and medium company that achieved the technical innovation and has an achievement of a global competitiveness with high technology. The small and medium company that want to get this cert. should take the technical inspection by OSLO manual that was developed by OECD.
This is not a certificate. This is an approval by the Korean government that helps a manufacturer achieve funding for their ventures.
Purpose for selecting and awarding GD products is to contribute to export and national economy through encouraging design development, helping develop good design products, and boosting competitiveness of Korean products -to meet the demands of the public and to improve the quality of life through taking product design to a higher level -to further develop industrial design through raising public awareness and interest in industrial design.
