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美科實業有限公司

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    工厂认证 (2)

    • Established in 1878, SGS transformed grain trading in Europe by offering innovative agricultural inspection services.
SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity.
We enable you to demonstrate that your products, processes, systems or services are compliant with either national or international standards and regulations or customer defined standards, through certification.
    • TÜV Rheinland Product Safety and Quality Certification marks show that manufacturer's products have met applicable safety requirements and quality standards. They are valued marketing tools. When consumers see a TÜV Rheinland Product Safety and Quality Certification mark, they can be assured that they are buying a safe product that has been investigated to particular safety requirements by an accredited third party and is supported by regular surveillance audits. To compete in today's marketplace, companies need certified management systems

    产品认证 (3)

    • The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[5] and veterinary products.

The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
    • Established in 1878, SGS transformed grain trading in Europe by offering innovative agricultural inspection services.
SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity.
We enable you to demonstrate that your products, processes, systems or services are compliant with either national or international standards and regulations or customer defined standards, through certification.
    •  GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters  A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.  This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.