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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 […]

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 therapy products on-site. Manufacturing transitions require adherence to current Good Manufacturing Practice (cGMP) to ensure that treatments are safe and

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 and manufacturers in the United States.   However, it is