再来一个尴尬话题：对于无菌工艺生产的无菌药品，如果培养基灌装失败，

qeirelpy00

peaches, grapes, figs, apples only 5 mg, pear contains only 4 mg. It has been determined, the adult day need 60 mg of vitamin C from the vitamin C content of fruit intake, figs 25, 14 pear, grapes need about 1.5 kg. Therefore, eat twelve less vitamin C content of fruit, actually not going to help. However, with high vitamin C kiwi, citrus or persimmon, one or two a day is enough. Fresh dates or strawberry long as fifty-six, you can ingest daily requirement of vitamin C So, in order to supplement enough vitamin C, eat the fruit should have a choice. In addition, there are some factors that affect the content of vitamin C in the fruit. For example, some of the fruit in order to prevent pests and sun in the growth process commonly used paper bags wrapped up, resulting in a decrease in vitamin C content; summer fruit harvest, storage in cold storage, the vitamin C content of the fruit will also reduce winter sale; modern family generally have a refrigerator, and many people like to buy a lot of fruit into. However, fruit storage time is longer, the more vitamin C loss. The fruit also bloodshed was wrong: fruit nutrients, eat good people. Actually, this is not the case. For example, apples contain sugar and potassium, eat a lot of adverse cardiac, coronary heart disease, myocardial infarction, nephritis, diabetes patients should not eat; cool citrus sex, stomach upset, kidney lung function Deficiency of the elderly can not eat; pears with The more sugar, people with diabetes to eat more cause blood sugar; the persimmon Coach Factory Outlet contains tannin persimmon plastic phenol, gastrointestinal bad or constipation patients should eat less, or easy to form diospyrobezoar; the pineapple contains rich Coach Outlet in vitamins A,  B, C, citric acid, such as protease and digestion diarrhea, antihypertensive diuretic effect. However, some idiosyncratic people ate occurs bursts of abdominal pain, and even vomiting and other indications, best good cut pineapple on the salt water soak and then heating to eat. The fruit why can drunk, drunk many aura spreads language problems tongue, cheeks fever tingling, dizziness standing firm ... are drunk harbinger hangover of  excessive drinking often need hangover. A lot of Coach Outlet Store Online people know, eat some with a sour fruit or Beverage 1-2 two clean vinegar hangover. What is the reason for this? This is because, the fruit-containing organic acids, for example, apples contain contains citric acid, malic acid, citrus and grapes containing tartaric acid, the main component of the wine is ethanol, and organic acids can form esters with ethanol interaction The material so as to achieve the purpose of hangover. Similarly, vinegar hangover because vinegar containing 3-5% acetic acid, ethyl acetate could ethanol esterification reaction. Interference by a variety of factors, but due to the esterification reaction in vivo with sour fruit and vinegar can be alleviated with the anesthetic effects of excessive ethanol, the effect is not very satisfactory. Therefore, the best way
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陶洋

不知道理解的对不对，如果失败了是否应该进行风险评估？因为PDA认为失败的不能代表你之前的不合格，也无法代表你未来的合格，因此我觉得首先是你要进行评估吧。
评估了以后再分析你的过程，这期间按目前官员（至少是我遇到的）理解应该是不允许你进行生产的。但是个人认为是可以的，只要你的评估结果你可以接受就可以边进行生产边进行分析原因。而且还考虑一些特定的因素如果没有简称过程的重新操作是无法分析出来的。这个和偏差是一样的。分析只是为了应答一些事情，你谁也不是福尔摩斯，呵呵

药仙

问题没有调查清楚之前是不能生产的

min930

其实这个问题不需要特别的关注已经明确的答案，倒是后面的循证比较不错哦

一沙一叶

培养基模拟灌装其实灵敏度也不是很高，如果它不符合标准，那么很可能无菌出现问题。为了保证质量，建议停下来找原因。

funfunq

应该先分析原因，然后纠正出CAPA，然后验证

碧水蓝天2013

讨论很激烈，学习了

Duruo168

培养基模拟灌装试验的目的是为工艺验证铺路的，因为只有这个结果符合要求，我们才能开始工艺验证，可是无菌检查大约需要14天，很多人都很难实现等着培养结果出来后再处理，通常都是在做过之后就开始工艺验证了

大笨熊

那还搞毛，不把原因查找出来，生产出来也是报废，先把基础做好了，生产起来就顺当多了

andyouandme

张必府

myreebok 发表于 2011-11-30 16:06
大家看了自己理解吧，我觉得andyouandme的说法是没有错，但是还是没有回答楼主的问题，这里提点自己的看法， ...

我赞同你的观点。

张必府

andyouandme 发表于 2011-11-30 16:22
就是这一段，而且PDA还有更深入的讨论。

如果有好的理解跟建议，拿出来给大家分享不是很好的一件事情吗？

肥羊羊

有多少企业做到了每一支培养基都合格的？

马进

没调查完你知道原因吗，盲目生产还是失败呢，逻辑都讲不通，只有先找到原因，制定措施，再生产，

伊甸

herman 发表于 2011-11-30 10:31
呵呵，我一直就是做无菌制剂的，而且最最近连做了10批冻干粉针，我没觉得做这个有什么难的。什么叫符合科学 ...

呵呵，不知检查时你也是这么挑战检查员嘛