MEDICINES CONTROL COUNCIL - sahpra.org.za

This document is intendedto serve as guidance on the requirements for Good Manufacturing Practice in South Africa. This guideline is not intended as an exclusive approach.

MEDICINES CONTROL COUNCIL - sahpra.org.za

Annex 12 Use of ionising radiation in the manufacture of medicinal products – cont. 12.5.1 . General : 96 . 12.5.2 : Gamma irradiators A Design . 96

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SOUTH AFRICAN HEALTH PRODUCTS …

www.ursonline.co.za URS 24099 The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act,

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Medicines Control Council - sahpra.org.za

Registration of Medicines Reporting of Adverse Drug Reactions 2.11_ADR_reporting_May03_v1_2.doc December 2012 Page 2 of 18 TABLE OF CONTENTS Page 1 Introduction 4

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MEDICINES CONTROL COUNCIL - sahpra.org.za

Registration of Medicines Amendments . 2.08_Amendments_Jul12_v6_showing_changes August 2012 . Page 1 of 43. MEDICINES CONTROL COUNCIL . AMENDMENTS

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MEDICINES CONTROL COUNCIL - sahpra.org.za

6.01 MRF1 Medicine Registration Application (Human) - replaced by ZA-CTD . 6.02 MRF2 Screening of Application* 6.03 MRF4 Package Insert Amendments*

  Applications

Government Gazette Staatskoerant - sahpra.org.za

"(z) the category of medicine immediately preceding the registration or application number; (aa) the pharmacological classification of the medicine; and

Registration of Medicines Stability MEDICINES …

Registration of Medicines Stability 2.05_Stability_Jul12_v7_1 Page August 2012 1 of 27 MEDICINES CONTROL COUNCIL STABILITY This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of

  Stability

MEDICINES CONTROL COUNCIL - sahpra.org.za

Registration of Medicines CMs DS Safety & Efficacy 7.01_CMs_SE_DS_Jun16_v3.doc June 2016 Page 1 of 46 MEDICINES CONTROL COUNCIL COMPLEMENTARY MEDICINES - DISCIPLINE-SPECIFIC

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POLICY ON MANAGEMENT OF POTENTIAL …

MEDICINES CONTROL COUNCIL POLICY ON MANAGEMENT OF POTENTIAL CONFLICT OF INTEREST NOVEMBER 2011. 1 INTRODUCTION. Section 6(4) of the Medicines and Related Substances Act 101 of 1965 “The ,

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

Committee of Human Medicinal Products . ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients– questions and answers . Step 5 . Transmission to CHMP . ... ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers

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Q 7 Good Manufacturing Practice for Active …

Good Manufacturing Practice for Active Pharmaceutical Ingredients Step 5 ... (medicinal) products, and manufacturing/control aspects specific to radiopharmaceuticals. Section 19 contains guidance that only applies to the manufacture of APIs used in the production of drug (medicinal) products specifically for clinical trials (investigational ...

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Good Manufacturing Practices (GMP) for Medicinal Products

Good Manufacturing Practices (G MP) for Medicinal Products 103 Fig. 1. Sources of Risk from Drug Products (Source: USFDA CDER 2001) Sulfanilamide, a drug used to treat Streptococcal infections, had been shown to have dramatic curative effects and had been used safe ly for some time in tablet and powder form.

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Good Manufacturing Practice (GMP) -What

Good Manufacturing Practice (GMP) ... to be capable of consistently manufacturing medicinal products of the required quality and complying with specifications. zCritical steps of the process and significant changes to the process are validated. EU Blood Directive: 2002/98/EC

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