近日，FDA發布了Omni Lens Pvt. Ltd.的警告信。該公司僅有一條GMP的違規缺陷便足以引起FDA警告信，即“質量部門未能履行其責任，確保所生產的藥品符合 CGMP，并符合既定的特性、含量、質量和純度標準 ”。

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

該公司沒有有效地履行監督CMO 生產操作質量的責任，該 CMO 缺乏充分設計的無菌生產車間來生產滴眼液，并且沒有對無菌過程執行動態氣流可視化研究，也未對含苯扎氯銨的眼科產品的進行質量檢測

FDA還表示：許多藥品生產商使用獨立合同機構，例如生產工廠、分析實驗室、包裝商和貼標商。FDA 將他們視為生產商的延伸。無論與合同機構簽訂了何種協議，都應對藥品的質量負責。

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).

貴公司的質量部門未能履行其責任，確保所生產的藥品符合 CGMP，并符合既定的特性、含量、質量和純度標準 （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量部門 （QU） 來執行適當的程序和控制措施，以確保藥品的生產符合 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） 代表執行生產、加工和包裝活動。你們從這些CMO 那里收到了藥品，并在進口記錄中將你們公司聲明為制造商。你們將質量部門（QU）職責委派給CMO。例如，你們的協議規定你們“將確保藥品符合法規和指令所有規定的責任分包給 （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，貴公司未能為你們的 CMO 提供足夠的監督和程序，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督CMO 生產操作質量的責任。根據貴公司提供的文件，貴公司的 CMO 缺乏充分設計的無菌生產車間來生產滴眼液，并且沒有執行以下操作：

Dynamic airflow visualization studies for aseptic processing

對無菌工藝的動態氣流可視化研究

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

含苯扎氯銨的眼科產品的(b)(4)有效性檢測

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.

請參閱 FDA 指南：藥品 CGMP 法規的質量體系方法，以幫助實施質量體系和風險管理方法，以符合21 CFR 第 210 和 211 部分的CGMP 法規。

In your response to this letter, provide:

回復此函，請提供：

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:

全面的評估和補救計劃，以確保你們的 QU 獲得有效運行的權利和資源。評估還應包括但不限于：

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健和適當

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

對整個操作過程提供QU監督的規定，以評估對適當規范的符合情況

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，對每個批次及其相關信息進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

監督和批準調查并履行所有其他 QU 職責，以確保所有產品的特性、含量、質量和純度

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量保證和可靠運營，包括但不限于及時提供資源以主動解決新出現的生產/質量問題并確保持續的受控狀態。