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Release is the final step in the pharmaceutical manufacturing process. For the release process of sterile drugs, more attention should be paid to the level of microbial control in the production process. This article starts with the main contents of inspection during release assessment...

Drug quality and safety is not only related to corporate reputation and future development, but also closely related to people’s health. If drug safety and quality cannot be guaranteed, it will cause huge hidden dangers to social and economic development. Drugs are important...

This article introduces several sterilization methods for sterile medicines: moist heat sterilization, dry heat sterilization, radiation sterilization, ethylene oxide sterilization and sterilization filtration, and studies the sterilization principles and effects of various sterilization...

The new version of GMP puts forward specific requirements for cleaning validation and risk control, emphasizing that all parts in contact with drugs must use “repeatable” and “recordable” cleaning methods to remove residues in the production process, aiming...

Emerging cell therapies aim to produce cell populations for clinical indications such as cancer, autoimmune and cardiovascular diseases. As hospitals and translational institutions explore implementing this technology, they are simultaneously evaluating whether to manufacture cell...

Foreword   Blister packs, and four-side seal pouches are two popular forms of primary packaging systems. In Europe, 85% of solid dosage forms are packaged in blisters in the US, less than 20%. However, due to its advantages, blister packs are increasingly accepted by consumers...

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,...

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...

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...

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:...