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近日，F(xiàn)DA發(fā)布了Omni Lens Pvt. Ltd.的警告信。該公司僅有一條GMP的違規(guī)缺陷便足以引起FDA警告信，即“質(zhì)量部門未能履行其責(zé)任，確保所生產(chǎn)的藥品符合 CGMP，并符合既定的特性、含量、質(zhì)量和純度標(biāo)準(zhǔn) ”。

該公司使用合同制造組織 （CMO） 代表執(zhí)行生產(chǎn)、加工和包裝活動(dòng)。FDA在警告信中披露：該公司將質(zhì)量部門（QU）職責(zé)委派給CMO。例如，在與CMO的協(xié)議中規(guī)定：將確保藥品符合法規(guī)和指令所有規(guī)定的責(zé)任分包給CMO。FDA表示：通過委派 QU 職責(zé)，該公司未能為 CMO 提供足夠的監(jiān)督和程序，以確保他們按照 CGMP 操作。

該公司沒有有效地履行監(jiān)督CMO 生產(chǎn)操作質(zhì)量的責(zé)任，該 CMO 缺乏充分設(shè)計(jì)的無菌生產(chǎn)車間來生產(chǎn)滴眼液，并且沒有對(duì)無菌過程執(zhí)行動(dòng)態(tài)氣流可視化研究，也未對(duì)含苯扎氯銨的眼科產(chǎn)品的進(jìn)行質(zhì)量檢測(cè)

FDA還表示：許多藥品生產(chǎn)商使用獨(dú)立合同機(jī)構(gòu)，例如生產(chǎn)工廠、分析實(shí)驗(yàn)室、包裝商和貼標(biāo)商。FDA 將他們視為生產(chǎn)商的延伸。無論與合同機(jī)構(gòu)簽訂了何種協(xié)議，都應(yīng)對(duì)藥品的質(zhì)量負(fù)責(zé)。

警告信缺陷翻譯如下：

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

貴公司的質(zhì)量部門未能履行其責(zé)任，確保所生產(chǎn)的藥品符合 CGMP，并符合既定的特性、含量、質(zhì)量和純度標(biāo)準(zhǔn) （21 CFR 211.22）。

Your firm lacked an adequate quality unit (QU) to exercise appropriate procedures and controls to ensure your over-the counter (OTC) drug products are manufactured in compliance with CGMP.

貴公司缺乏足夠的質(zhì)量部門 （QU） 來執(zhí)行適當(dāng)?shù)某绦蚝涂刂拼胧?，以確保藥品的生產(chǎn)符合 CGMP。

Your firm utilized contract manufacturing organizations (CMOs) to perform manufacturing, processing, and packaging activities on your behalf. You received drug products from these CMOs and declared your firm as the manufacturer on import records. You delegated the QU responsibilities to your CMOs. For example, your agreement with(b)(4) states that you “sub-contract to (b)(4) the responsibility for ensuring that the products comply with all provision of the Regulations and Directive.”

貴公司使用合同制造組織 （CMO） 代表執(zhí)行生產(chǎn)、加工和包裝活動(dòng)。你們從這些CMO 那里收到了藥品，并在進(jìn)口記錄中將你們公司聲明為制造商。你們將質(zhì)量部門（QU）職責(zé)委派給CMO。例如，你們的協(xié)議規(guī)定你們“將確保藥品符合法規(guī)和指令所有規(guī)定的責(zé)任分包給 （b）（4）”。

By delegating your QU responsibilities, your firm failed to have adequate oversight and procedures for your CMOs to ensure they operate in compliance with CGMPs. The records and information you provided demonstrate that your firm did not effectively exercise its responsibilities to oversee the quality of your CMO’s manufacturing operations. According to documentation provided by your firm, your CMO lacks an adequately designed aseptic processing room where ophthalmic drop products are manufactured and has not performed the following:

通過委派 QU 職責(zé)，貴公司未能為你們的 CMO 提供足夠的監(jiān)督和程序，以確保他們按照 CGMP 操作。你們提供的記錄和信息表明，貴公司沒有有效地履行監(jiān)督CMO 生產(chǎn)操作質(zhì)量的責(zé)任。根據(jù)貴公司提供的文件，貴公司的 CMO 缺乏充分設(shè)計(jì)的無菌生產(chǎn)車間來生產(chǎn)滴眼液，并且沒有執(zhí)行以下操作：

Dynamic airflow visualization studies for aseptic processing

對(duì)無菌工藝的動(dòng)態(tài)氣流可視化研究

(b)(4) effectiveness testing for benzalkonium chloride containing ophthalmic products

含苯扎氯銨的眼科產(chǎn)品的(b)(4)有效性檢測(cè)

See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.

請(qǐng)參閱 FDA 指南：藥品 CGMP 法規(guī)的質(zhì)量體系方法，以幫助實(shí)施質(zhì)量體系和風(fēng)險(xiǎn)管理方法，以符合21 CFR 第 210 和 211 部分的CGMP 法規(guī)。

In your response to this letter, provide:

回復(fù)此函，請(qǐng)?zhí)峁?/span>

A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:

全面的評(píng)估和補(bǔ)救計(jì)劃，以確保你們的 QU 獲得有效運(yùn)行的權(quán)利和資源。評(píng)估還應(yīng)包括但不限于：

A determination of whether procedures used by your firm are robust and appropriate

確定貴公司使用的程序是否穩(wěn)健和適當(dāng)

Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices

對(duì)整個(gè)操作過程提供QU監(jiān)督的規(guī)定，以評(píng)估對(duì)適當(dāng)規(guī)范的符合情況

A complete and final review of each batch and its related information before the QU disposition decision

在 QU 處置決定之前，對(duì)每個(gè)批次及其相關(guān)信息進(jìn)行完整和最終的審查

Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products

監(jiān)督和批準(zhǔn)調(diào)查并履行所有其他 QU 職責(zé)，以確保所有產(chǎn)品的特性、含量、質(zhì)量和純度

Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.

此外，描述最高管理層如何支持質(zhì)量保證和可靠運(yùn)營，包括但不限于及時(shí)提供資源以主動(dòng)解決新出現(xiàn)的生產(chǎn)/質(zhì)量問題并確保持續(xù)的受控狀態(tài)。