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The document outlines the structure and processes related to the Egyptian Pharmacopoeia, including definitions of key terms and the roles of various groups involved in the development and evaluation of pharmaceutical monographs. It details the requirements for submitting Active Pharmaceutical Ingredient (API) and Finished Pharmaceutical Product (FPP) monographs, including validation data and technical evaluations. Additionally, it provides guidelines for laboratory verification analysis and includes referen

Author

Nesrin M.Ali

Language

EN