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RAW MATERIAL RISK ASSESSMENTS - BioPhorum
www.biophorum.com2 ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Section 1.3, Scope 3 EU (2015/C 95/02), Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use, Chapter 2.3
ICH HARMONISED TRIPARTITE GUIDELINE
www.ich.orgGOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an
ICH Q7 API GMP Guide - gmpeye.co.kr
www.gmpeye.co.krICH GMP Guide for Active Pharmaceutical Ingredients GI001A ggmmppeeyyee www.gmpeye.co.kr 69 일상 제조 및 공정 관리에 적용할 것으로 예상되는 주요 …