China Pharmacopoeia (2005 edition) clearly pointed out in the appendix "Verification of analytical methods for drug quality standards": "The purpose of verification of analytical methods for drug quality standards is to prove that the adopted methods are suitable for the corresponding detection requirements, and the analytical methods need to be verified when formulating drug quality standards; When the pharmaceutical production process changes, the preparation composition changes and the original analysis method is modified, the quality standard analysis method also needs to be verified. The reason, process and result of method verification should be recorded in the "Notes on Drafting or Revision of Drug Standards". In addition, the China Pharmacopoeia (2005 edition) aseptic inspection method and microbial limit inspection method also clearly stipulate the verification contents of aseptic inspection method and microbial limit inspection method: "When the test conditions of the test product are changed, the method verification test should be carried out to confirm that the test product has no antibacterial activity or its antibacterial activity can be ignored under the test conditions. When verifying, operate in accordance with the provisions of "Sample Sterility Inspection" and the following requirements. The bacteriostatic degree of the test sample to each test bacteria should be verified one by one "; "When the test product is a new product or the test conditions of the test product change, a method verification test shall be conducted to confirm the antibacterial activity of the test product and the reliability of the determination method. Verification shall be carried out according to the methods specified in sample preparation and counting of bacteria, molds and yeasts and the following requirements. The recovery rate of each test bacterium should be verified one by one. " Why do you need methodology validation? This is because many drugs (such as antibiotics and drugs containing preservatives) have antibacterial properties, which will affect the test results. Therefore, before microbial detection, it is necessary to properly pretreat the sample to eliminate the interference caused by the sample itself. Similarly, the pretreatment methods, inspection conditions and culture conditions of samples will also affect the microbial detection results of samples. Therefore, when determining the microbial inspection of new products or developing new inspection methods or changing the original inspection conditions, verification must be carried out to ensure the accuracy, effectiveness and reproducibility of the inspection methods under the actual inspection conditions when determining the microbial inspection of new products or developing new inspection methods or changing the original inspection conditions.