Ⅰ、the US USP certification
1. Authoritative third-party certification of the world's only, independent and comprehensive quality and quality system;
2. Demonstrate to your customers the product authority and the GMP system's dual reliable authority certification;
3. Important criteria for the selection of component suppliers by global component users;
4. Improve the quality management system of the company to an internationally recognized level;
5. The most convincing “identity card” and “passport” for products entering the US market and the global market;
6. The USP will award a "Certificate of Standard Compliance" and a "USP Certification Mark". The logo can be used on packaging containers for certified products, inspection reports (COA), advertising, and other promotional materials to demonstrate that product quality and GMP systems are strictly certified by USP.
Ⅱ、the value of US US certification
Quality, globally harmonized certification.
In the past 100 years, USP has established the world's most influential, most widely used and most authoritative standards for pharmaceutical substances and food supplements. USP has become a globally recognized symbol of the “quality standard” for pharmaceuticals and pharmaceutical substances. Therefore, the USP component certification means that the product meets the requirements of the US USP, the highest standard for pharmaceuticals and food supplements in the world. This is undoubtedly the most convincing “ID card” and “passport” for products entering the US market and the global market. .
USP certification is performed by the FDA, so the FDA recognizes its effectiveness and gradually considers its possible alternatives in the FDA's regulatory compliance process. USP certification has also been recognized by many regulatory authorities around the world.
The USP component certification program does not require activation of the formulation user and can be applied directly to the USP, thereby shortening the time and period of certification. After the certification, the certificate will be obtained and authorized to use the USP certification mark.
The USP component certification process will greatly enhance the company's quality management system to an internationally recognized level.
Ⅲ、the project objectives
In the time agreed with the customer, Kanglihua helps customers obtain the USP component certification; improve the quality management system of the company to an internationally recognized level, so that the company's products can smoothly enter the US, Europe and global markets.