Manufacturing practice guidance for active pharmaceutical ingredients

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ICH HARMONISED TRIPARTITE GUIDELINE

www.ich.org

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 …

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Q7 Q&A - good manufacturing practice for active ...

www.ema.europa.eu

ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37

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Annex 3 WHO good manufacturing practices for ...

www.who.int

193 1. Introduction 1.1 These guidelines set out good practices applicable to facilities handling pharmaceutical products (including active pharmaceutical

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Certified Pharmaceutical Good Manufacturing Practices ...

asq.org

Certified Pharmaceutical GMP Professional 3 Examination Each certification candidate is required to pass a written examination that consists of multiple choice ...

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POLICY GUIDELINES FOR APPROVAL OF FIXED DOSE …

www.cdsco.nic.in

Page 1 of 61 POLICY GUIDELINES FOR APPROVAL OF FIXED DOSE COMBINATIONS (FDCs) IN INDIA DRAFT GUIDANCE This guidance document is for feedback purposes only

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Q7 Implementation Working Group ICH Q7 Guideline: Good ...

www.ich.org

Dated : 10 June 2015 Q7 Q&As 1 PREFACE Since the ICH Q7 Guidance was finalised, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due

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MEDICINES CONTROL COUNCIL - sahpra.org.za

www.sahpra.org.za

Registration of Medicines CMs DS Safety & Efficacy 7.01_CMs_SE_DS_Jun16_v3.doc June 2016 Page 4 of 46 Back to ToC 1 INTRODUCTION i) Purpose The purpose of this Guideline is to provide clear guidance with regards to the safety and efficacy (SE)

Guidance