驗(yàn)證專業(yè)應(yīng)知應(yīng)會(huì)學(xué)習(xí)rev0106-01ich指導(dǎo)

1、 ICH指導(dǎo)規(guī)范 宋啟國 目 錄1、ICH介紹2、ICH法規(guī)結(jié)構(gòu)3、ICH Q類法規(guī)介紹劃1、ICH介紹 為了嚴(yán)格管理藥品，必須對(duì)藥品的研制、開發(fā)、生產(chǎn)、銷售、進(jìn)品等進(jìn)行審批，形成了藥品的注冊(cè)制度。但是不同國家對(duì)藥品注冊(cè)藥品各不相同，這不僅不利于病人在藥品的安全性、有效性和質(zhì)量方面得到科學(xué)的保證及國際技術(shù)和貿(mào)易交流，同時(shí)也造成制藥工業(yè)和科研、生產(chǎn)部門人力、物力的浪費(fèi)，不利于人類醫(yī)藥事業(yè)的發(fā)展。因此，由美國、日本和歐盟三方的政府藥品注冊(cè)主管部門和制藥行業(yè)在1990年發(fā)起的ICH(人用藥物注冊(cè)技術(shù)要求國際協(xié)調(diào)會(huì)議，International Conference on Harmonization

2、of Technical Requirements for Registration of Pharmaceuticals for Human Use)就是這樣應(yīng)運(yùn)而生的。劃1、ICH法規(guī)結(jié)構(gòu)ICH的論題主要分為四類，因此ICH根據(jù)論題的類別不同而進(jìn)行相應(yīng)的編碼分類：1. “Q”類論題：Q代表QUALITY，指那些與化工和醫(yī)藥，質(zhì)量保證方面的相關(guān)的論題。2. “S”類論題：S代表SAFETY，指那些與實(shí)驗(yàn)室和動(dòng)物實(shí)驗(yàn)，臨床前研究方面的相關(guān)的論題。3. “E”類論題：E代表EFFICACY，指那些與人類臨床研究相關(guān)的課題。4. “M”類論題：M代表MULTIDISCIPLINARY, 指那些不可

3、單獨(dú)劃入以上三個(gè)分類的交叉涉及的論題。同時(shí)M又細(xì)分為5個(gè)小類M1: 常用醫(yī)學(xué)名詞 （MedDRA）M2: 藥政信息傳遞之電子標(biāo)準(zhǔn)M3: 與臨床試驗(yàn)相關(guān)的臨床前研究時(shí)間的安排M4: 常規(guī)技術(shù)文件(CTD)M5: 藥物詞典的數(shù)據(jù)要素和標(biāo)準(zhǔn)劃1、ICH Q類法規(guī)介紹Q1: Stability穩(wěn)定性Q1A(R2): Stability Testing of New Drug Substances and Products 新原料藥和制劑的穩(wěn)定性試驗(yàn)Q1B: Photostability Testing of New Drug Substances and Products新原料藥和制劑的光穩(wěn)定性試驗(yàn)Q

4、1C: Stability Testing for New Dosage Forms新劑型的穩(wěn)定性試驗(yàn)Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料藥和制劑穩(wěn)定性試驗(yàn)的交叉和矩陣設(shè)計(jì)Q1E: Evaluation of Stability Data穩(wěn)定性數(shù)據(jù)的評(píng)估Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV 在氣候帶II

5、I和IV，藥物注冊(cè)申請(qǐng)所提供的穩(wěn)定性數(shù)據(jù)劃1、ICH Q類法規(guī)介紹Q2: Analytical Validation分析驗(yàn)證Q2(R1): Validation of Analytical Procedures: Text and Methodology分析程序的驗(yàn)證：正文及方法論劃1、ICH Q類法規(guī)介紹Q3: Impurities 雜質(zhì)Q3A(R2): Impurities in New Drug Substances 新原料藥中的雜質(zhì)Q3B(R2): Impurities in New Drug Products (Revised Guideline)新制劑中的雜質(zhì)Q3C(R3): Im

6、purities: Guideline for Residual Solvents雜質(zhì)：殘留溶劑指南Impurities: Guideline for Residual Solvents (Maintenance) 雜質(zhì)：殘留溶劑指南(保留)劃1、ICH Q類法規(guī)介紹Q4: Pharmacopoeias藥典Q4A: Pharmacopoeial Harmonisation 藥典的協(xié)調(diào)Q4B: Evaluation and mendation of Pharmacopoeial Texts for Use in the ICH Regions藥典內(nèi)容的評(píng)估及推薦為用于ICH地區(qū)Q4B Annex

7、1 Evaluation and mendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter附錄1 藥典內(nèi)容的評(píng)估及推薦為用于ICH地區(qū) 關(guān)于灼燒殘?jiān)?灰分 常規(guī)篇Q4B Annex2 Evaluation and mendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Pr

8、eparations General Chapter附錄2 藥典內(nèi)容的評(píng)估及推薦為用于ICH地區(qū) 關(guān)于注射劑可提取容量測(cè)試 常規(guī)篇Q4B Annex3 Evaluation and mendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter附錄3 藥典內(nèi)容的評(píng)估及推薦為用于ICH地區(qū) 關(guān)于顆粒污染物測(cè)試:不溶性微粒 常規(guī)篇?jiǎng)?、ICH Q類法規(guī)介紹Q5: Quality of Bi

9、otechnological Products 生物技術(shù)制品質(zhì)量Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin來源于人或者動(dòng)物細(xì)胞系的生物技術(shù)產(chǎn)品的病毒安全性評(píng)估Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein

10、Products生物技術(shù)產(chǎn)品的質(zhì)量：源于重組DNA的蛋白質(zhì)產(chǎn)品的生產(chǎn)中所用的細(xì)胞中的表達(dá)構(gòu)建分析Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products生物技術(shù)產(chǎn)品的質(zhì)量：生物技術(shù)/生物產(chǎn)品的穩(wěn)定性試驗(yàn)Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products用于生產(chǎn)生物技術(shù)/生物產(chǎn)

11、品的細(xì)胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process基于不同生產(chǎn)工藝的生物技術(shù)產(chǎn)品/生物產(chǎn)品的可比較性劃1、ICH Q類法規(guī)介紹Q6: Specifications 規(guī)格Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Su

12、bstances (including decision trees)質(zhì)量規(guī)格：新原料藥和新制劑的檢驗(yàn)程序和可接收標(biāo)準(zhǔn)：化學(xué)物質(zhì)(包括決定過程)Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products質(zhì)量規(guī)格：生物技術(shù)/生物產(chǎn)品的檢驗(yàn)程序和可接收標(biāo)準(zhǔn)劃1、ICH Q類法規(guī)介紹Q7: Good Manufacturing Practices （GMP）Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性藥物成份的GMP指南劃1、ICH Q類法規(guī)介紹Q8: Pharmaceutical Developm