Ending ‘Magical Thinking’ in Compounding
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.
Read this article in Pharmaceutical Technology's Regulatory Sourcebook October 2020 eBook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook
October 2020
Pages: 46-51
Citation
When referring to this article, please cite it as A. Shanley, “Ending ‘Magical Thinking’ in Compounding," Pharmaceutical Technology Regulatory Sourcebook eBook (October 2020).
FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy
March 25th 2025Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.
