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1 Jul 2018 PE 009-14 (Part II). 1 July 2018. GUIDE TO GOOD MANUFACTURING. PRACTICE FOR MEDICINAL PRODUCTS. PART II. Developed by the This document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients 1 Jul 2018 Good Manufacturing Practice for Medicinal Products (GMP) . .. Table of contents. PE 009-14 (Part I). - ii -. 1 July 2018. Sampling . EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. rules governing medicinal products in the European Union" contains guidance for Part II - Basic Requirements for Active Substances used as Starting Materials Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which15 Jan 2009 Good Manufacturing Practice is that part of Quality Assurance which ensures e. approved procedures and instructions;. PE 009-8 (Part I). - 2 -.