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ICH Quality 目录 和所有章节
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下周面试一个 late stage pharmaceutical development group leader. 这两天狂补 ICH、GMP。没做过late stage，心里没底啊。 趁机把下载的文件整理汇总下：附件一是word版目录；附件二是word版的各个章节。 （备注：全是英文的，没有中文翻译） 其实都是从ICH网站下载的，大家可以自己去下。 Stability Q1A - Q1F Q1A(R2)Stability Testing of New Drug Substances and Products Q1A Q1BStability Testing : Photostability Testing of New Drug Substances and Products Q1CStability Testing for New Dosage Forms Q1DBracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1EEvaluation of Stability Data Q1FStability Data Package for Registration Applications in Climatic Zones III and IV Analytical Validation Q2 Q2(R1)Validation of Analytical Procedures: Text and Methodology Impurities Q3A - Q3D Q3A(R2)Impurities in New Drug Substances Q3B(R2)Impurities in New Drug Products Q3C(R5)Impurities: Guideline for Residual Solvents Q3C, Q3C(M) Q3DImpurities: Guideline for Elemental Impurities Pharmacopoeias Q4 - Q4B Code Document Title Previously coded Q4Pharmacopoeias Q4APharmacopoeial Harmonisation Q4BEvaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Q4B Annex 1R1Residue on Ignition/Sulphated Ash General Chapter Q4B Annex 2R1Test for Extractable Volume of Parenteral Preparations General Chapter Q4B Annex 3R1Test for Particulate Contamination: Sub-Visible Particles General Chapter Q4B Annex 4AR1Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Q4B Annex 4BR1Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter Q4B Annex 4CR1Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Q4B Annex 5R1Disintegration Test General Chapter Q4B Annex 6R1Uniformity of Dosage Units General Chapter Q4B Annex 7R2Dissolution Test General Chapter Q4B Annex 8R1Sterility Test General Chapter Q4B Annex 9R1Tablet Friability General Chapter Q4B Annex 10R1Polyacrylamide Gel Electrophoresis General Chapter Q4B Annex 11Capillary Electrophoresis General Chapter Q4B Annex 12Analytical Sieving General Chapter Q4B Annex 13Bulk Density and Tapped Density of Powders General Chapter Q4B Annex 14Bacterial Endotoxins Test General Chapter Q4B FAQsFrequently Asked Questions Quality of Biotechnological Products Q5A - Q5E Code Document Title Previously coded Q5A(R1)Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginQ5A Q5BAnalysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5CStability Testing of Biotechnological/Biological Products Q5DDerivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Q5EComparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Specifications Q6A- Q6B Code Document Title Previously coded Q6ASpecifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6BSpecifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Good Manufacturing Practice Q7 Code Document Title Previously coded Q7Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsQ7A Q7 Q&AsQuestions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Pharmaceutical Development Q8 Code Document Title Previously coded Q8(R2)Pharmaceutical Development Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation Quality Risk Management Q9 Code Document Title Previously coded Q9Quality Risk Management Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation Pharmaceutical Quality System Q10 Code Document Title Previously coded Q10Pharmaceutical Quality System Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation Development and Manufacture of Drug Substances Q11 Code Document Title Previously coded Q11Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Cross-cutting Topics Code Document Title Previously coded Cross-cutting Guidelines |
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