TAIWAN BIOTECH CO., LTD.

Certification

  • Taiwantrade Advanced Verified

    Advanced check: The company's legal existence is checked against a government database. The company's operating status is third-party verified by Dun & Bradstreet/TÜV Rheinland.

  • The D&B D-U-N-S® Number is D&B's distinctive nine-digit identification sequence, which links you to a wealth of quality information products and services originating exclusively from D&B. The D&B D-U-N-S® Number is an internationally recognized common company identifier in EDI and global electronic commerce transactions.

The world's most influential standards-setting organizations, more than 50 global, industry and trade associations, and the U.S. Federal Government recognize, recommend and/or require the D&B D-U-N-S® Number.

D&B D-U-N-S® Numbers are the key to building corporate family relationships in the D&B file. Since each location of a business may have its own unique D&B D-U-N-S® Number, a large organization is likely to have many different D&B D-U-N-S® Numbers within its corporate "family." D&B links the D&B D-U-N-S® Numbers of parents, subsidiaries, headquarters and branches on more than 70 million corporate family members around the world.

    The D&B D-U-N-S® Number is D&B's distinctive nine-digit identification sequence, which links you to a wealth of quality information products and services originating exclusively from D&B. The D&B D-U-N-S® Number is an internationally recognized common company identifier in EDI and global electronic commerce transactions. The world's most influential standards-setting organizations, more than 50 global, industry and trade associations, and the U.S. Federal Government recognize, recommend and/or require the D&B D-U-N-S® Number. D&B D-U-N-S® Numbers are the key to building corporate family relationships in the D&B file. Since each location of a business may have its own unique D&B D-U-N-S® Number, a large organization is likely to have many different D&B D-U-N-S® Numbers within its corporate "family." D&B links the D&B D-U-N-S® Numbers of parents, subsidiaries, headquarters and branches on more than 70 million corporate family members around the world.

  • The verification certificate for TAITRA aims to ensure the qualification of a supplier who is going to join Taiwantrade e-commerce platform. Business information such as company name/address, email address, company ID, telephone number, employee number, revenue, main product, management personnel, etc. will be verified by TUV Rheinland Taiwan to guarantee the authenticity. After that, verification certificate and test mark will be issued with validity of one year.

Company Certification (2)

  •  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.
  • ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Product Certification (1)

  •  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.