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In a recent Warning Letter, the FDA criticised the fact that not all parameters of a process were included in a process validation. What are the follow-up measures?在最近的一封警告信中，美國食品藥品監(jiān)督管理局（FDA）批評了一個(gè)事實(shí)，即并非某一工藝的所有參數(shù)都被納入了工藝驗(yàn)證中。后續(xù)措施有哪些？

Referring to 21 CFR 211.100 (a), the FDA stated: "Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess."美國食品藥品監(jiān)督管理局（FDA）參考《聯(lián)邦法規(guī)匯編》第21篇第211.100（a）節(jié)指出：“貴公司未能制定充分的書面生產(chǎn)和工藝控制程序，以確保所生產(chǎn)的藥品具備其聲稱或宣稱應(yīng)有的特性、效價(jià)、質(zhì)量和純度。”

In general, the FDA criticised the insufficient validation of the manufacturing process - as well as the missing parameters in procedures and in batch documentation that are relevant to quality. The authority further addressed the lack of qualification of production equipment. So much for the deficiencies.總體而言，美國食品藥品監(jiān)督管理局（FDA）批評了生產(chǎn)工藝驗(yàn)證不足的問題，以及程序和批次文件中與質(zhì)量相關(guān)的參數(shù)缺失的問題。該機(jī)構(gòu)還指出了生產(chǎn)設(shè)備資質(zhì)不足的問題。以上就是存在的缺陷。

With reference to the FDA process validation guideline, the FDA outlined what it understands by process validation. In the Warning Letter, it described the validation life cycle, beginning with the development of a product and the implementation of the control strategy. Process qualification studies are then to demonstrate that the control strategy works.參考美國食品藥品監(jiān)督管理局（FDA）的工藝驗(yàn)證指南，F(xiàn)DA概述了其對工藝驗(yàn)證的理解。在警告信中，它描述了驗(yàn)證生命周期，始于產(chǎn)品的開發(fā)和控制策略的實(shí)施。然后，工藝確認(rèn)研究將證明該控制策略是有效的。

What does the FDA require?FDA有哪些要求？

Following the FDA directly required:遵循FDA的直接要求：

A risk assessment and the follow-up measures necessary for products on the market without process validation.對未經(jīng)工藝驗(yàn)證就上市的產(chǎn)品進(jìn)行的風(fēng)險(xiǎn)評估及必要的后續(xù)措施。

A detailed risk assessment addressing the potential problems of the systems under consideration with regard to medicinal products on the market within the expiry date.一份詳細(xì)的風(fēng)險(xiǎn)評估，用于解決在考慮范圍內(nèi)的系統(tǒng)針對有效期內(nèi)市售藥品可能存在的問題。

Measures such as customer information and product recalls based on the above risk assessment. 基于上述風(fēng)險(xiǎn)評估的客戶信息和產(chǎn)品召回等措施。

Repeated inspection findings 重復(fù)的檢查結(jié)果

The FDA further pointed out in the Warning Letter that the same deficiencies were found in a previous inspection in 2019. Although the company promised to take corrective action, nothing happened. The FDA considered this to be a failure on the part of senior management, which should have an overview of the manufacturing process. 美國食品藥品監(jiān)督管理局在警告信中進(jìn)一步指出，2019年的一次先前檢查中就發(fā)現(xiàn)了同樣的缺陷。盡管該公司承諾會采取糾正措施，但并未有任何實(shí)際行動。美國食品藥品監(jiān)督管理局認(rèn)為，這是高級管理層的失職，他們本應(yīng)對生產(chǎn)過程進(jìn)行全面監(jiān)督。

CGMP consultant recommended  CGMP顧問建議

Due to the nature of the inspection findings, the FDA recommended to consult a CGMP consultant. Their qualifications should meet the requirements of 21 CFR 211.34. However, calling in a consultant does not exempt senior management from their responsibility to remedy the deficiencies and comply with CGMP.  鑒于檢查結(jié)果的性質(zhì)，美國食品藥品監(jiān)督管理局（FDA）建議咨詢一位現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范（CGMP）顧問。其資質(zhì)應(yīng)符合《聯(lián)邦法規(guī)匯編》第21篇第211.34條的要求。然而，聘請顧問并不能免除高級管理層糾正缺陷和遵守現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范的責(zé)任。

Conclusion: Process validation covers all process steps and all critical parameters. Indirectly, the FDA also requires a risk assessment to identify these. Furthermore, products that are on the market without validation must be critically examined.結(jié)論：過程驗(yàn)證涵蓋所有過程步驟和所有關(guān)鍵參數(shù)。間接而言，美國食品藥品監(jiān)督管理局（FDA）還要求通過風(fēng)險(xiǎn)評估來識別這些內(nèi)容。此外，對于未經(jīng)驗(yàn)證就上市的產(chǎn)品，必須進(jìn)行嚴(yán)格檢查。