驗證主計劃和驗證計劃之間的關聯性

In a news item from 19 March 2025, we described deficiencies in microbiological tests of non-sterile products. However, the warning letter in question provides further information: on process validation. What was criticized?

在2025年3月19日的一篇新聞中（內容見文末），我們描述了非無菌產品的微生物檢測缺陷。然而，有問題的警告信提供了進一步的信息：關于工藝驗證，批評了什么？

The 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.

FDA發現，雖然在驗證主計劃中對工藝驗證和保持時間有要求，但在驗證方案本身中沒有規定操作條件，如批次保持時間、工藝限值或工藝參數的接受標準。

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FDA的說法，該方案仍然沒有說明保持時間和其他細節，例如取樣信息和用于第一個驗證批次的批次報告。隨后，FDA引用了其工藝驗證指南，并在警告信的一小部分中描述了指南的內容。

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。與預期用途相反，（水）系統在不運行時停止循環。也缺乏根據美國藥典（USP）對化學和微生物參數的監測。被檢查的公司對未來永久運行該系統的回復是不夠的。整個系統的設計還有待評估和監測。此外，FDA要求采取臨時措施并調查錯誤驗證系統對產品質量的影響