中文字幕一级黄色A级片|免费特级毛片。性欧美日本|偷拍亚洲欧美1级片|成人黄色中文小说网|A级片视频在线观看|老司机网址在线观看|免费一级无码激情黄所|欧美三级片区精品网站999|日韩av超碰日本青青草成人|一区二区亚洲AV婷婷

FDA's requirements for approval of new and generic drugs and biologics are among the highest standards across the globe. Prior to FDA approval, manufacturers must prove that their products are high quality, safe, effective, and free of contamination and defects. In addition, manufacturers of non-application products, such as over-the-counter and homeopathic products, are responsible for adhering to quality standards. Pharmaceutical manufacturers, no matter where they are located, are responsible for complying with Current Good Manufacturing Practice and ensuring that only quality products reach U.S. patients.

FDA對(duì)新藥、仿制藥和生物制品的批準(zhǔn)要求是全球最高的標(biāo)準(zhǔn)之一。生產(chǎn)商必須在FDA批準(zhǔn)之前，證明他們的產(chǎn)品是高質(zhì)量、安全、有效的，并且無(wú)污染和缺陷。此外，無(wú)需申請(qǐng)藥物預(yù)批準(zhǔn)的生產(chǎn)商，例如OTC和順勢(shì)療法產(chǎn)品，其需要負(fù)責(zé)確保產(chǎn)品符合質(zhì)量標(biāo)準(zhǔn)。藥物生產(chǎn)商，無(wú)論其在何處，都要保證生產(chǎn)符合現(xiàn)行GMP的要求，并確保只有質(zhì)量合格的產(chǎn)品才會(huì)用于美國(guó)患者。

To help ensure that high-quality drugs are sold in the U.S., CDER maintains a comprehensive quality surveillance program. A critical function of this program is testing selected drugs in FDA laboratories. This includes testing active pharmaceutical ingredients (APIs). FDA laboratories generally test drugs to standards set by the U.S. Pharmacopeia (USP), a scientific organization that sets minimum standards for the quality of medicines including:

為了確保高質(zhì)量的藥物在美國(guó)銷(xiāo)售，CDER采用一個(gè)全面的質(zhì)量監(jiān)督程序。該程序的一個(gè)關(guān)鍵功能是在FDA實(shí)驗(yàn)室檢測(cè)選定的藥物。這也包括檢測(cè)活性物質(zhì)（APIs）。FDA實(shí)驗(yàn)室通常按照美國(guó)藥典(USP)制定的標(biāo)準(zhǔn)檢測(cè)藥物，USP是一個(gè)科學(xué)組織，為藥品質(zhì)量制定最低標(biāo)準(zhǔn)，包括:

-        Identity – is it the right drug as indicated on the label?

-        鑒別——這是標(biāo)簽上標(biāo)明的正確藥物嗎？

-        Assay – how much drug is there and is it consistent with the labeled amount?

-        含量——有多少藥物？其與標(biāo)示量一致嗎？

-        Impurities – are there process impurities or degradation impurities?

-        雜質(zhì)——有工藝雜質(zhì)和降解雜質(zhì)產(chǎn)生嗎？

-        Dissolution – does the active ingredient dissolve out of the dosage unit so that the drug is available for the body to absorb?

-        溶出度——活性成分能從制劑單元里面溶出以便人體吸收嗎？

CDER’s quality surveillance program includes multiple tools that complement sampling and testing, including inspections, evaluation of post-market quality reports, signal detection, and data analysis.

CDER的質(zhì)量監(jiān)督程序包括多種工具，以補(bǔ)充抽樣和檢測(cè)，包括審計(jì)、上市后質(zhì)量報(bào)告的評(píng)估、信號(hào)檢測(cè)和數(shù)據(jù)分析。

We are committed to protecting patients and consumers from unsafe, ineffective or poor-quality drugs.

我們致力于保護(hù)患者和消費(fèi)者免受不安全、無(wú)效或劣質(zhì)藥物的侵害。

Testing

檢測(cè)

We use a risk-based approach to quality testing. This means that in cases where there is a known or likely safety, effectiveness, or quality issue with a product, FDA scientists perform specific tests for this vulnerability. As you can see in the results below, the majority of drugs FDA tests meet their specifications.

我們使用基于風(fēng)險(xiǎn)的方法進(jìn)行質(zhì)量檢測(cè)。這意味著，在產(chǎn)品存在已知或可能的安全性、有效性或質(zhì)量問(wèn)題的情況下，F(xiàn)DA科學(xué)家會(huì)針對(duì)這一漏洞進(jìn)行特定的檢測(cè)。正如你在下面的結(jié)果中所看到的，大多數(shù)FDA檢測(cè)的藥物都符合其標(biāo)準(zhǔn)。

Beginning in 2018, CDER began using data analytics, including post-market quality data, to identify products that have potential quality risks. This more targeted, risk-based approach for sampling and testing has been effective in helping us identify more products per year that fail quality tests than in the years prior to 2018.

從2018年開(kāi)始，CDER開(kāi)始使用數(shù)據(jù)分析，包括上市后質(zhì)量數(shù)據(jù)，來(lái)識(shí)別具有潛在質(zhì)量風(fēng)險(xiǎn)的產(chǎn)品。與2018年之前相比，這種更具針對(duì)性、基于風(fēng)險(xiǎn)的抽樣和測(cè)試方法有效地幫助我們每年識(shí)別出更多未通過(guò)質(zhì)量檢測(cè)的產(chǎn)品。

If drug products have unfavorable testing results, we work swiftly to protect the public from potential harm. We share information with health care professionals and consumers to help them make decisions. In addition, we alert the manufacturer of the need to take measures to correct the problem underlying the unfavorable test results. We continue to monitor the situation until the manufacturer demonstrates compliance with FDA rules and regulations.

如果藥品有不合格的檢測(cè)結(jié)果，我們會(huì)迅速采取行動(dòng)，保護(hù)公眾免受潛在的傷害。我們與醫(yī)療保健專(zhuān)業(yè)人員和消費(fèi)者共享信息，幫助他們做出決定。此外，我們警告生產(chǎn)商要采取措施糾正引發(fā)不合格檢測(cè)結(jié)果的潛在問(wèn)題。我們會(huì)持續(xù)監(jiān)測(cè)直至生產(chǎn)商證明其符合FDA的法規(guī)要求。

具體的檢測(cè)結(jié)果可見(jiàn)下方列表：