Reference strains refer to the reference substances used for identification, inspection, content determination and calibration of the performance of calibration instruments, while standard strains refer to the reference substances used for bioassay, antibiotic or biologic drug content or titer determination, expressed in titer unit (U). Test products refer to the test samples to be identified and determined. The following Xiaobian take you to understand the difference between the control product and the test product in detail!

The difference between control product and test product:

Control product:

Standard substances used for identification, inspection, content determination and calibration of the performance of calibration instruments;

The reference product shall be reviewed and approved by the national drug verification agency, and its standard shall not be lower than the quality standard of the product.

Test product:

A standard substance used for the determination of content or titer in bioassays, antibiotics or biologic drugs, expressed in titer units (U). In the literature, the two concepts are often confused, and the reference product is the standard product, which is only one kind of substance and two kinds of formulation. The reason for the error may be that some drugs have both reference products and test products.

The management of test products shall follow the following principles:

On the basis of following the GLP standard, the total quantity control, condition control and process control of the test products are implemented. However, in practice, due to the large number of links, departments and personnel involved, how to implement effective management of the test products is an important issue in front of the manager.

Storage of test products:

Proper storage is the key factor to ensure the quality of test products, and its storage conditions must meet the requirements of the client. How to prevent the contamination and confusion of the test products is the key issue of management, to ensure the consistency and controllability of the storage conditions, it is recommended to replace the ordinary refrigerator with a drug storage cabinet, configure a temperature and humidity recorder with an alarm device, and implement 24-hour recording and monitoring of the temperature and humidity in the storage place.

A detailed emergency plan should be formulated, which should include the transfer of test products, abnormal situation report, abnormal situation record, test product testing and other steps to ensure the quality of test products when the temperature and humidity conditions are out of control.

In order to prevent confusion and contamination of the test products, the test products and control products should be stored in separate rooms, so that the storage facilities are relatively independent.

Since most of the test products and control products in the safety evaluation study do not have standardized packaging, it is suggested to carry out secondary independent packaging on the basis of unified identification of the test products to prevent cross-contamination, packaging breakage and other phenomena.

The above content is the introduction of the difference between the reference product and the test product, the national standard product and biological reference product refers to the standard substance used for identification, inspection of content or titer determination, its preparation and calibration should meet the requirements of the "National standard material preparation and calibration procedures for biological products", and the drug regulatory department under The State Council designated by the agency distributed. Enterprise working standards or reference products must be standardized by national standards or reference products before use.