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Consistent product quality requires a clear understanding of the essence of CGMPs. Experts fear that the message is not always getting through to compounders.
Pharmaceutical compounding recalls the earliest days of medicine making, when the mortar and pestle, and variability, were the rule. Since that time, and the establishment of the United States Pharmacopeia (USP) and FDA in the United States, the field has come a long way.
eBook: Regulatory Sourcebook
When referring to this article, please cite it as A. Shanley, “Ending ‘Magical Thinking’ in Compounding," Pharmaceutical Technology Regulatory Sourcebook eBook (October 2020).