Quality Standards

NoroBio is making great efforts to ensure the safety and efficiency of its products supplied. The Quality Assurance Committee (QAC) of NoroBio regulates the screening, collection, and transportation of import and export drugs for customers and partners as well as ensures that individual product manufacturers to implement the strict and standard GMP in production and transportation. 

NoroBio ensures that all the products supplied are not only manufactured under China 's national GMP standard, but also should reach the standards which are commonly used in international communities, such as CGMP, COS, USP, BP and EP standard etc.

Meanwhile, during cooperation with customers, NoroBio ensures the business transactions are all under the quality and safety standards for products and procedures. NoroBio believes that quality is much more important than profit and growth, which are always ranked by management and Quality Assurance Committee after quality and safety matters.

Batch Release Control

To strengthen the quality management and ensure the safety and efficacy of biological products, we set the management measures for the batch release of bio-products according to Drug Administration Law of the PRC and Regulations for Implementation of The Drug Administration Law of The Peoples Republic of China.

The batch release of biological products is the compulsory inspection and audit system which applies to vaccines, plasma products, in vitro diagnostics and other biological products stated by State Food and Drug Administration before each batch enters into the market or is imported and exported. Products tested as unqualified or unapproved shall not enter into the market or be imported and exported.

State Food and Drug Administration takes charge of the batch release of biological products; while the institution which undertakes inspection and audit of batch release shall be designated by State Food and Drug Administration.
The policy of biologicals batch release shall be conformity with the current state regulations for biologicals or other specifications approved by State Food and Drug Administration. The batch release inspection and audit institution shall be equiped with appropriate staff and equipments and shall meet requirements of the related quality assurance system and technology.

The biological products which fail to meet the requirements of batch release shall be destroyed by the manufacturer according to the relevant regulation.