General Introduction To Gmp History Ich

ICH HARMONISED TRIPARTITE GUIDELINE

1 GOOD 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

  Introduction, Good, Practices, Manufacturing, Good manufacturing practice

Annex 2 - WHO

1. Introduction 1.1 Background and scope In most countries compliance with good manufacturing practices (GMP) (1, 2) (including validation), medicines regulatory activities and inspections, together with supply chain controls throughout the product life-cycle, provide good assurance that risks are largely controlled. However, where control is

  Introduction, Good, Practices, Manufacturing, Good manufacturing practice

Drug Regulation: History, Present and Future

rent Good Manufacturing Practices (GMP), to of-ficially register drug establishments and implement other requirements. The EEC Directive 65/65/EEC on the approximation of provisions laid down by law, regulation and administrative action relating to medicinal products was also induced by the thalido-mide disaster.

  Good, Practices, Manufacturing, History, Good manufacturing practice

ICH HARMONISED TRIPARTITE GUIDELINE

Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 6 October 1999, this guideline is recommended for adoption to the three regulatory parties to ICH

Pharma Change Control - FDAnews

including as expert for the FMEA and the International Conference on Harmonization (ICH). Thomas L. Peither is a GMP consultant for 18 years and an expert in the European GMPs. He co-founded the GMP publishing company Maas & Peither (Germany, USA) …

  International, Change, Control, Conference, Harmonization, Pharma, International conference on harmonization, Pharma change control