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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，并且無污染和缺陷。此外，無需申請藥物預(yù)批準(zhǔn)的生產(chǎn)商，例如OTC和順勢療法產(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)品才會用于美國患者。

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)量的藥物在美國銷售，CDER采用一個全面的質(zhì)量監(jiān)督程序。該程序的一個關(guān)鍵功能是在FDA實驗室檢測選定的藥物。這也包括檢測活性物質(zhì)（APIs）。FDA實驗室通常按照美國藥典(USP)制定的標(biāo)準(zhǔn)檢測藥物，USP是一個科學(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，包括審計、上市后質(zhì)量報告的評估、信號檢測和數(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、無效或劣質(zhì)藥物的侵害。

Testing

檢測

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)險的方法進(jìn)行質(zhì)量檢測。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)量問題的情況下，F(xiàn)DA科學(xué)家會針對這一漏洞進(jìn)行特定的檢測。正如你在下面的結(jié)果中所看到的，大多數(shù)FDA檢測的藥物都符合其標(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年開始，CDER開始使用數(shù)據(jù)分析，包括上市后質(zhì)量數(shù)據(jù)，來識別具有潛在質(zhì)量風(fēng)險的產(chǎn)品。與2018年之前相比，這種更具針對性、基于風(fēng)險的抽樣和測試方法有效地幫助我們每年識別出更多未通過質(zhì)量檢測的產(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結(jié)果，我們會迅速采取行動，保護(hù)公眾免受潛在的傷害。我們與醫(yī)療保健專業(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)不合格檢測結(jié)果的潛在問題。我們會持續(xù)監(jiān)測直至生產(chǎn)商證明其符合FDA的法規(guī)要求。

具體的檢測結(jié)果可見下方列表：