The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter. The document dated 28 June 2023 was published on the FDA webite on 18 July 2023.It refers to an inspection conducted in February 2023 at a drug manufacturing facility in Kansas, USA. The FDA writes that the company in questions manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers.
FDA近期發(fā)布了美國堪薩斯州的一家藥品制造廠的警告信。警告信2023 年 7 月 18 日在 FDA 官網(wǎng)上發(fā)布。
The Warning Letter lists the following main violations:
警告信列出了以下主要違規(guī)行為：
QU oversight: The Quality Unit (QU) did not provide adequate oversight for the manufacture of the products. Documents were not appropriately reviewed and several out-of-specification (OOS) results were not investigated. In addition, an adequate ongoing stability program was missing.
QU監(jiān)督：質(zhì)量部門（QU）未能對產(chǎn)品的生產(chǎn)提供足夠的監(jiān)督。未能適當(dāng)審查文件，也未能對多個(gè)OOS結(jié)果進(jìn)行調(diào)查。此外，還缺少適當(dāng)?shù)某掷m(xù)穩(wěn)定計(jì)劃。
Identity testing: Adequate identity testing of each component lot used in the manufacture was not performed. In addition, the company used the suppliers’ certificate of analysis (COA) without establishing the reliability of the suppliers’ test analyses. This concerns propylene glycol and ethanol.
鑒定測試：沒有對生產(chǎn)中使用的每個(gè)組分批次進(jìn)行適當(dāng)?shù)蔫b定測試。此外，該公司在沒有確定供應(yīng)商測試的可靠性的情況下使用了供應(yīng)商COA。包括丙二醇和乙醇。
Laboratory controls: It was not ensured that the test methods were appropriate for their intended use. In this context, the following quote shows how problematic GMP compliance seems to be in the laboratory: "Your analysts provided our investigator with a non-validated test method from an internet search, which did not appear to be specific for your drug products, nor appropriate for any drug product."
實(shí)驗(yàn)室控制：未能確保分析方法適合其預(yù)期用途。以下缺陷引述顯示了實(shí)驗(yàn)室中GMP合規(guī)性似乎存在嚴(yán)重問題：“你們的分析人員向我們的檢查人員提供了來自互聯(lián)網(wǎng)搜索的未經(jīng)驗(yàn)證的分析方法，該方法似乎不適用于你們的藥品，也不適合任何藥品。
The FDA asked the company to provide, beside others, the following information:
FDA要求該公司提供以下信息：
An assessment and remediation plan to ensure the QU can effectively function.
評估和補(bǔ)救計(jì)劃，以確保質(zhì)量部門能夠有效運(yùn)行。
An assessment of the overall system for investigating deviations, discrepancies, complaints, OOS results, and failures.
對調(diào)查偏差、差異、投訴、OOS 結(jié)果和失敗的整體系統(tǒng)的評估。
Several documents related to stability studies.
與穩(wěn)定性研究有關(guān)的文件。
A comprehensive review of the material system.
對物料系統(tǒng)的全面審查。
A risk assessment for all drug products that contain propylene glycol and ethanol.
所有含有丙二醇和乙醇的藥品的風(fēng)險(xiǎn)評估。
An assessment of the laboratory practices.
對實(shí)驗(yàn)室規(guī)范的評估。
The FDA concludes that"significant findings in this letter indicate that [the] QU is not able to fully exercise its authority and/or responsibilities" Based on the nature of the GMP violations, the FDA strongly recommends engaging a consultant.
FDA的結(jié)論是，“警告信中的重要發(fā)現(xiàn)表明，質(zhì)量部門無法充分行使其權(quán)力和/或責(zé)任”?；谶`反GMP的性質(zhì)，F(xiàn)DA強(qiáng)烈建議聘請顧問。
京公網(wǎng)安備11010802046783號
