Critical Factors for Standardizing the Compounding Process of Semi-Solid Formulations
Critical Factors for Standardizing the Compounding Process of Semi-Solid Formulations by Süsen Gülce Erismis, BPharm MSc. Standardization and Reproducibility A standardized compounding process refers to a consistent and well-defined set of procedures and practices that compounding pharmacies follow. According to United States Pharmacopeia (USP) 1 , this practice is essential for maintaining the safety, quality, and effectiveness of compounded medications as well as ensuring compliance with compounding requirements. The primary aim of standardization is to ensure reproducibility, which means that the resulting product consistently exhibits the same composition, quality, and attributes every time it is made, regardless of the person performing the compounding 2 . Automated equipment in pharmaceutical compounding ensures consistent processes by minimizing variations from individual compounders. These systems follow set protocols during each process, controlling factors like sp...