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1 Whole Process Quality Management? No Idea   During the inspection of the extension of the validity period of the drug GMP certificate, I encountered a manufacturer of injections, and did not inspect and control the amount of water used for bottle washing during the initial and fine washing processes of bottle washing. Even if

The sterility test of microspheres for injection should focus on both “outside sterility” and “inside sterility”, and the difficulty of detection is “inside sterility”, that is, the sterility test inside the microsphere. On the basis of investigating the production process of microspheres for injection, this study selected representative varieties, simulated the dissolution process of microspheres

Part 1 – Origin of Stability Test Placement Conditions   According to the concept proposed by W.Grimm (DrugsMade in Germany, 28:196-202, 1985 and 29:39-47. 1986), the world is divided into 4 climate zones according to the annual climate conditions.   Climate zone Ⅰ: temperate zone 21°C/45%RH Climate Zone Ⅱ: Subtropical 25°C/60%RH Climate zone Ⅲ: dry