Practical Considerations in Pharmaceutical Production Scale-Up
Source: WellSpring Pharma Services
Although some scale-ups are easier than others by virtue of their manufacturing process, scale-up is always a meticulous process of trial and error. For each stage of the scale-up process, the product must be physically and analytically tested against approved physical and analytical specifications and the critical process parameters must be challenged in order to ensure the process can be validated.
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