This study describes a documentation of sterile drug products of various regulatory agencies like Therapeutic Goods and Administration, European Union, Central Drugs Standard Control Organization, US Food and Drug Administration's Medicines and Healthcare Products Regulatory Agency Administrations Medical devices and pharmaceuticals Agenus and the National Institute of Health Sciences' Centre for the Evaluation of Pharmaceuticals and Medical Devices. The environment in which the technique is performed can introduce microbes that can contaminate sterile goods produced in staffed cleanrooms. This review article explains the many documents that are needed by various regulatory authorities. This work provides a comprehensive image of the documentation involved in numerous agencies when studied and seen

Sterile drug product, documentation, TGA, EU, MHRA, USFDA and PMDA