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As we all know, my country is currently implementing GMP regulations, which are formulated by the WHO and are applicable to developing countries. It is also called the dynamic drug production management specification, and its focus is on the production software. So, what are the differences between these two specifications? How do we overcome these […]

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 to reduce human errors , to reduce potential quality risks in the production process.   In recent

1 Overview Of Sterilization Of Sterile Drugs   Sterilization method refers to the method of killing or removing all surviving microbial propagules or spores by physical and chemical methods to make the sterilized items sterile. In the production of sterile drugs, the prevention of endotoxin contamination and microbial contamination has always been the focus of