ICHICHQ7A问答2018年4月版翻译稿，回答了哪些问题？
bolt是什么意思图片来源：quantamagazine
ICH Q7A 问&答2018年4月最新发布，在本次的问与答中，明确了很多之前一直被混淆或者不清楚的部分。
新东方考研班
以下为一些问题的选译，全文翻译稿，请在文末点击“原文链接”下载，或者加入齐力佳QQ群：252331465，在历史文件中下载。
When are dedicated production areas expected?
核实被期望建立专用的生产区域？
ICH Q7 expects dedicated production areas for highly nsitizing materials such as penicillins and cephalosporins becau of the patient risk (e.g., anaphylactic shock to penicillin-allergic patients) from trace amounts of the compounds in other medicines (ICH Q7, paragraph 4.40).
ICH Q7希望期望对高致敏性物质建立专用生产区，如青霉素和头孢菌素，因为其在其他药品组分中可能导致对患者的风险（例如, 青霉素过敏患者的过敏性休克）（ICH Q7，第4.40段）。
For materials of an infectious nature or high pharmacological activity or toxicity, a risk-bad approach should be ud to determine appropriate containment measures, which
最快学习英语的方法may include validated inactivation, cleaning, and/or dedicated production areas (ICH Q7, paragraph 4.41).想见你英文
对于具有传染性或高药理活性或毒性的材料，应采用基于风险的方法来确定合适的遏制措施，其中可能包括验证灭活，清洁和/或专用生产区（ICH Q7，第4.41段）。
While ICH Q7 does not define high pharmacological activity or toxicity, the characteristics are generally determined by evaluating relevant animal and human data collected during rearch and development. Important considerations in this evaluation of pharmacological activity or toxicity may include occupational exposure limit (OEL), permitted daily exposure (PDE), acceptable daily exposure (ADE), threshold for toxicological concerns (TTC), no obrved adver effect level (NOAEL) (ICH safety guidances; ICH E2E, ction II.A.1 (2.1.1)), and the conquences of cross-contamination (ICH Q9, ction IV.C (4.3)).
虽然ICH Q7没有定义高药理活性或毒性，但这些特征通常通过评估在研究和开发过程中收集的相关动物和人类数据来确定。 在评估药理活性或毒性时需要考虑的重要因素包括职业
接触限值（OEL），每日允许暴露量（PDE），可接受的每日接触量（ADE），毒理学关注阈值（TTC），未观察到的不良反应水平（NOAEL）（ ICH E2E，第II.A.1（2.1.1）节）以及交叉污染的后果（ICH Q9，第IV.C（4.3）节）
英文报价>四级准考证打印入口Should acceptance criteria for residues be defined for dedicated equipment?
毕业论文翻译是否应该为专用设备定义残渣验收标准？
es. Regardless of whether equipment is dedicated or not, it is expected that acceptance criteria for residues be defined and that the equipment be cleaned at appropriate intervals to prevent build-up and carry-over of contaminants. Intervals can be bad on number of batches, product change-over, time, etc. (ICH Q7, paragraphs 5.22, 5.23, 5.24, 5.25, 8.50).
justthewayyouare
是。 无论设备是否专用，预计可定义残渣的验收标准，并在适当的时间间隔对设备进行清洁，以防止污染物积聚和遗留。 间隔可以基于批次数，产品转换，时间等（ICH Q7，第5.22,5.2,5.24,5.25， 8.50).
yinyinCleaning intervals and acceptance criteria should be established bad on an understanding of the process/reactions/degradation, taking into account solubility, potency, toxicity, etc. Establishment of acceptance criteria does not necessarily imply sampling and testing after every cleaning. Visual inspection of equipment for cleanliness is an expectation of ICH Q7, paragraph 5.21. Where validation data has confirmed effective cleaning, cleaning procedures should be monitored at appropriate intervals (ICH Q7, paragraph 12.76).
我的英文单词
