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近日，F(xiàn)DA對(duì)Medinatura New Mexico, Inc.的警告信中，提及工藝驗(yàn)證相關(guān)缺陷：

在新增藥品品類及新設(shè)備時(shí)，未能對(duì)工藝驗(yàn)證進(jìn)行妥善更新

上一次正式的驗(yàn)證是 2007 年，迄今已有18年

上一次工藝驗(yàn)證時(shí)，公司的所有權(quán)歸屬與現(xiàn)在不同

缺陷翻譯如下：

Your firm failed to establish 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 (21 CFR 211.100(a)).

貴公司未能建立書面的生產(chǎn)與工藝控制程序，以確保所生產(chǎn)的藥品具備其聲稱或標(biāo)注的鑒別特征、效價(jià)、質(zhì)量及純度（21 CFR 211.100(a)）。

You have not adequately validated your production and process controls used to manufacture your homeopathic drug products, including “(b)(4) tablets” and “(b)(4),” which are labeled for (b)(4). Your drug products contain potentially hazardous components (for example, (b)(4)).

貴公司用于生產(chǎn)順勢(shì)療法藥品的生產(chǎn)及工藝控制未經(jīng)過(guò)充分驗(yàn)證。貴公司的藥品含有潛在危險(xiǎn)性組分（例如，（b)(4)））。

In your response, you acknowledged that you have not been properly updating your process validations when new drug products and equipment are added, and your last official validation study was completed in 2007, when the company was under different ownership. You committed to using your current manufacturing data to update your process validation.

在貴公司的回復(fù)中，貴方承認(rèn)在新增藥品品類及新設(shè)備時(shí)，未能對(duì)工藝驗(yàn)證進(jìn)行妥善更新；同時(shí)承認(rèn)上一次正式的驗(yàn)證完成于 2007 年，彼時(shí)公司的所有權(quán)歸屬與現(xiàn)在不同。貴方承諾將利用現(xiàn)有生產(chǎn)數(shù)據(jù)對(duì)工藝驗(yàn)證進(jìn)行更新。

Your response is inadequate. You did not provide details about how you will conduct process validation for all your products, including the products containing potentially hazardous components. Also, you did not provide a risk assessment and any follow-up actions to be taken for distributed drug products produced without performing appropriate process validation.

貴公司的回復(fù)內(nèi)容不充分。貴方既未詳細(xì)說(shuō)明將如何對(duì)所有產(chǎn)品（包括含有潛在危險(xiǎn)性組分的產(chǎn)品）開(kāi)展工藝驗(yàn)證，也未針對(duì)未經(jīng)充分工藝驗(yàn)證就已上市銷售的藥品，提交風(fēng)險(xiǎn)評(píng)估報(bào)告及擬采取的后續(xù)措施。

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.

工藝驗(yàn)證用于評(píng)估某一工藝在其全生命周期內(nèi)的設(shè)計(jì)合理性及受控狀態(tài)。生產(chǎn)工藝的每一個(gè)關(guān)鍵階段均需經(jīng)過(guò)恰當(dāng)設(shè)計(jì)，且需保障原輔料投入、中間產(chǎn)品及成品的質(zhì)量。工藝確認(rèn)研究需在每一個(gè)關(guān)鍵工藝階段開(kāi)展密集的監(jiān)測(cè)與檢測(cè)，以明確批內(nèi)的變異性，并通過(guò)對(duì)批次的評(píng)估判斷是否已建立初始受控狀態(tài)。工藝確認(rèn)研究需在產(chǎn)品商業(yè)化上市前完成，且需達(dá)到合格標(biāo)準(zhǔn)。在此之后，需對(duì)工藝性能及產(chǎn)品質(zhì)量進(jìn)行持續(xù)嚴(yán)格的監(jiān)督，以確保在產(chǎn)品全生命周期內(nèi)維持穩(wěn)定的生產(chǎn)運(yùn)操作。

See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.

關(guān)于 FDA 認(rèn)定的工藝驗(yàn)證相關(guān)恰當(dāng)要素的通用原則與方法，詳見(jiàn) FDA 指導(dǎo)文件《工藝驗(yàn)證：一般原則與實(shí)踐》。

In response to this letter, provide the following:

回復(fù)此函，請(qǐng)?zhí)峤灰韵拢?/span>

A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ) and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.

提交一份詳細(xì)總結(jié)，說(shuō)明貴公司用于確保產(chǎn)品全生命周期受控狀態(tài)的驗(yàn)證方案及相關(guān)規(guī)程。闡述貴公司的工藝性能確認(rèn)（PPQ）方案，以及針對(duì)批內(nèi)和批間變異開(kāi)展的持續(xù)監(jiān)測(cè)方案，以此保障工藝維持持續(xù)受控狀態(tài)。

A timeline for performing appropriate PPQ for each of your marketed drug products. Also, provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing appropriate process validation studies.

提交針對(duì)每一款在售藥品開(kāi)展恰當(dāng)工藝性能確認(rèn)（PPQ）的時(shí)間表。同時(shí)，針對(duì)未經(jīng)充分工藝驗(yàn)證就已上市銷售的藥品，提交風(fēng)險(xiǎn)評(píng)估報(bào)告及擬采取的后續(xù)措施。

Process performance protocol (s), and written procedures for qualification of equipment and facilities.

提交工藝性能方案，以及設(shè)備與設(shè)施確認(rèn)的書面規(guī)程。

A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.

提交一份詳細(xì)方案，說(shuō)明貴公司對(duì)各生產(chǎn)工藝進(jìn)行設(shè)計(jì)、驗(yàn)證、維護(hù)、控制及監(jiān)測(cè)的具體措施，其中需包含對(duì)批內(nèi)和批間變異的嚴(yán)格監(jiān)測(cè)，以保障工藝的持續(xù)受控狀態(tài)。同時(shí)，該方案需納入貴公司的設(shè)備與設(shè)施確認(rèn)方案。

An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control.

針對(duì)每一款藥品的生產(chǎn)工藝開(kāi)展評(píng)估，確保存在一套基于數(shù)據(jù)且具備科學(xué)合理性的方案，能夠識(shí)別并控制所有變異來(lái)源，從而使生產(chǎn)工藝持續(xù)符合適用的質(zhì)量標(biāo)準(zhǔn)及生產(chǎn)規(guī)范。評(píng)估內(nèi)容包括但不限于：評(píng)估設(shè)備是否適用于既定用途、監(jiān)測(cè)與檢測(cè)系統(tǒng)的檢出能力是否充足、投入原輔料的質(zhì)量狀況，以及各生產(chǎn)工藝步驟與控制措施的可靠性。