At present, my country's Institute of Pharmaceutical and Biological Products has provided 2930 kinds of national standard products, including 650 kinds of traditional Chinese medicine chemical reference substances and 730 kinds of reference substances.

Standard

Regarding the handling of standard products, the main points are as follows:

source problem

According to the relevant rules, the sources of the standards used in the inspection of my country's pharmaceutical products are: first, the standard products provided for the inspection of drugs and biological products in China; the national; Standard. However, during our on-site inspection, we found that some pharmaceutical manufacturers use refined APIs or "working standards" for some reasons. "Working standard" refers to a drug product used as a standard (control) whose known content is calibrated in this laboratory. The handling of work standard products requires that standard products be replaced by standard products for product inspection.

Problems in use

Use the questions in the homework standard. Although the operating standards have been agreed by the relevant departments, relevant documents are required, such as the standardization date, re-marking date, storage conditions, usage, etc. and records, but some enterprises do not meet the above requirements. Most enterprises do not stipulate the period of re-bidding and storage conditions. Once they are calibrated, their period of use is not verified until the end of their use period; some enterprises have incomplete records, and the use of operating standards cannot be traced back to the source.