Comparison of Quality Requirements for Sterile Product Manufacture as Per Indian GMP and USFDA

摘要

ABSTRACT The purpose of the present work was to make a detailed study of the Quality requirements for sterile product manufacture as per the regulatory authorities such as Indian GMP (Schedule M) and USFDA. The pharmaceutical companies are required to follow the quality management specifications as per different guidelines such as Indian GMP (Schedule M) and USFDA. Sterile pharmaceutical products are very critical and sensitive. The specific requirements of these products are that these product.