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What was FDA criticized on process validation?

關于工藝驗證，F(xiàn)DA批評了什么？

Correlation between Validation Master Plan and Validation Protocols

驗證主計劃和驗證方案之間的相關性

In warning letter 320-25-43, FDA found that although there were requirements in the Validation Master Plan for process validation and hold times, no operating conditions such as bulk hold times, process limits or acceptance criteria for process parameters were specified in the validation protocol itself.

在警告信320-25-43中，F(xiàn)DA 發(fā)現(xiàn)，盡管驗證主計劃中對工藝驗證和保持時間有要求，但驗證方案本身并未指定操作條件，例如待包裝產(chǎn)品保持時間、工藝限度或工藝參數(shù)的接受標準。

Inadequate Process Validation

工藝驗證不充分

You did not have data to demonstrate that you adequately validate your manufacturing processes used to manufacture your OTC drug products and demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality. For example, your validation plan, “VALIDATOIN MASTER PLAN (VMP),” describes requirements for process validation and hold time studies. However, the protocol implementing your validation planed, “PROCESS VALIDATION PROTOCOL,” failed to include operating parameters, such as bulk hold times, or processing limits, such as acceptance criteria for process parameters.

你們沒有數(shù)據(jù)證明充分驗證了用于生產(chǎn)藥品的制造工藝，并證明該工藝是可重復的和可控的，可以始終如一地生產(chǎn)出具有一致特性和質(zhì)量的藥物。例如，你們的 “驗證主計劃（VMP）”描述了工藝驗證和保持時間研究的要求。但是，實施驗證計劃的 “工藝驗證方案”未能包括作參數(shù)（如批保持時間）或工藝限度（如工藝參數(shù)的接受標準）。

In response, the inspected company submitted an updated validation protocol which, according to the FDA, still failed to address hold times and other details, such as information on sampling and the batch report that is used for the first validation batch. Subsequently, the FDA refers to its process validation guideline and describes the content of the guideline in a short section of the warning letter. 

作為回復，被檢查的公司提交了一份更新的驗證方案，根據(jù) FDA 的說法，該方案仍然未能解決保持時間和其他細節(jié)，例如取樣信息和用于第一個驗證批次的批次報告。隨后，F(xiàn)DA 引用了其工藝驗證指南，并在警告信的一小節(jié)中描述了指南的內(nèi)容。

Another point of criticism was the equipment. Contrary to the intended use, the circulation of the (water) system was stopped when it was not in operation. There was also a lack of monitoring of both chemical and microbiological parameters in accordance with the US Pharmacopoeia (USP). The response of the inspected company to operate the system permanently in the future is not sufficient. The entire system design is still to be assessed and monitoring introduced. In addition, the FDA requires interim measures and an investigation into the impact of the incorrectly validated system on product quality.

另一個批評點是設備。不符合預期使用，（水）系統(tǒng)在未運行時，循環(huán)被停止。此外，還缺乏根據(jù)美國藥典（USP） 對化學和微生物參數(shù)的監(jiān)測。被檢查公司在未來永久運行該系統(tǒng)的回復是不夠的。整個系統(tǒng)設計仍有待評估和監(jiān)控。此外，F(xiàn)DA 要求采取臨時措施并調(diào)查驗證錯誤的系統(tǒng)對產(chǎn)品質(zhì)量的影響。

Inadequate Control of(b)(4) System

對 （b）（4） 系統(tǒng)的控制不足

Your firm uses(b)(4) as a component to manufacture your OTC drug product. You failed to ensure that your (b)(4) system is suitable for producing (b)(4) used in the formulation of your drug product. For example, you turned your (b)(4) system off when not in use, stopping its circulation, which deviates from its design use as a continuously recirculating system. In addition, you failed to demonstrate that your (b)(4) system is adequately monitored to ensure it consistently produces (b)(4) that meets appropriate chemical and microbial attributes.

貴公司使用 （b）（4） 作為生產(chǎn)藥物的組成部分。你們未能確保你們的（b）（4）系統(tǒng)適合生產(chǎn)。例如，你們在不使用時關閉了（b）（4）系統(tǒng)，停止了其循環(huán)，這偏離了其作為連續(xù)循環(huán)系統(tǒng)的設計用途。此外，你們未能證明你們的（b）（4）系統(tǒng)受到充分監(jiān)控，以確保其始終產(chǎn)生符合適當化學和微生物屬性的（b）（4）。

The FDA also expects a validation program, detailed PPQ plans, timelines for the PPQ, maintenance information, a description of monitoring and an assessment of the impact of defects on customer information and recalls.

FDA 還希望有一個驗證計劃、詳細的 PPQ計劃、PPQ 的時間表、維護信息、監(jiān)控描述以及對缺陷對用戶和召回影響的評估。