Regulatory Pharma Blogs
Production Department in Pharmaceutical Industry Production Department-The process of Drug Manufacturing performed in Production Department in Pharmaceutical Unit into a series of unit operations, such as dispensing, granulation, coating, tablet pressing, blistering, mixing, filling, and others. Table of Contents Production General Process Air Flow Pattern Under LFA in Aseptic Processing SOP: This SOP outlines the …
How SAS v4 using For Bioequivalence Data analysis SAS Bioequivalence data analysis-SAS SAS is commonly employed in the analysis of bioequivalence (BE) data. On the other hand, R, a freely available open-source software for general-purpose data analysis, sees less frequent use than SAS in BE data analysis. This tutorial elucidates the utilization of R for …
Regulatory response & Quality Trends for 2024 Regulatory response :ICH Q9 Quality Risk Management Regulatory response in 2023, significant changes have impacted drug manufacturers, particularly with the revised ICH Q9 guidance on quality risk management. This has prompted companies to reassess their quality risk management plans, ensuring their effectiveness in proactively addressing issues rather than …