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Film coating technology is to use a certain process to coat a coating material on the surface of the drug, which can play various functions such as beautification, protection and control of the drug effect as expected. This technology can overcome the shortcomings of many medicines, such as bitter taste, rough surface of the tablet […]

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