您當前的位置：檢測資訊 > 生產品管
嘉峪檢測網 2025-03-10 11:45
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要求是全球最高的標準之一。生產商必須在FDA批準之前，證明他們的產品是高質量、安全、有效的，并且無污染和缺陷。此外，無需申請藥物預批準的生產商，例如OTC和順勢療法產品，其需要負責確保產品符合質量標準。藥物生產商，無論其在何處，都要保證生產符合現行GMP的要求，并確保只有質量合格的產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:
為了確保高質量的藥物在美國銷售，CDER采用一個全面的質量監督程序。該程序的一個關鍵功能是在FDA實驗室檢測選定的藥物。這也包括檢測活性物質（APIs）。FDA實驗室通常按照美國藥典(USP)制定的標準檢測藥物，USP是一個科學組織，為藥品質量制定最低標準，包括:
- Identity – is it the right drug as indicated on the label?
- 鑒別——這是標簽上標明的正確藥物嗎？
- Assay – how much drug is there and is it consistent with the labeled amount?
- 含量——有多少藥物？其與標示量一致嗎？
- Impurities – are there process impurities or degradation impurities?
- 雜質——有工藝雜質和降解雜質產生嗎？
- 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的質量監督程序包括多種工具，以補充抽樣和檢測，包括審計、上市后質量報告的評估、信號檢測和數據分析。
We are committed to protecting patients and consumers from unsafe, ineffective or poor-quality drugs.
我們致力于保護患者和消費者免受不安全、無效或劣質藥物的侵害。
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.
我們使用基于風險的方法進行質量檢測。這意味著，在產品存在已知或可能的安全性、有效性或質量問題的情況下，FDA科學家會針對這一漏洞進行特定的檢測。正如你在下面的結果中所看到的，大多數FDA檢測的藥物都符合其標準。
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開始使用數據分析，包括上市后質量數據，來識別具有潛在質量風險的產品。與2018年之前相比，這種更具針對性、基于風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量檢測的產品。
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果，我們會迅速采取行動，保護公眾免受潛在的傷害。我們與醫療保健專業人員和消費者共享信息，幫助他們做出決定。此外，我們警告生產商要采取措施糾正引發不合格檢測結果的潛在問題。我們會持續監測直至生產商證明其符合FDA的法規要求。
具體的檢測結果可見下方列表：
來源：Internet
