Design And Validation Of Pharmaceutical Ferric Oxide GMP Workshop Modification

Pharmaceutical excipients played a vital role in drug safety. For the time being, many issues exist in the administration and circulation of pharmaceutical excipients in China. Incidents like injections with wrong raw-materials in Qiqihaer 2nd pharmaceutical manufacturer, the concealed contaminated methotrexate incident, poisoned capsules and etc. Such problems has reflected the ponderance of drug safety problem we face. Thus, it is a must for the manufacturer of pharmaceutical excipients to obey the GMP and make changes to meet the demand of law.This article focused on the solution for medicinal ferric oxide workshop modification, including the design of workshop, process layout, devices selection, process validation. This modification aimed at solving the dust problem, lowering the risk of cross contamination to meet the GMP demand. In this way, the continuing improvement will promote the enterprise to better their product quality and serve the people better and ensure a better vision.