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Product Transfer: Is a Transfer Plana required GMP Document?

產(chǎn)品轉移：轉移計劃是必需的GMP文件嗎？

A frequently askedquestion in product/technology transfer courses is: is a transfer plan arequired GMP document?

產(chǎn)品/技術轉移中的一個常見問題是：轉移計劃是否是必需的GMP文件？

The questionwhether a Transfer Plan is a "must have document" from a GMP point ofview is already answered with "yes" in the Transfer SOP in mostpharmaceutical companies. It should be mentioned here that the aforementionedTransfer SOP is also a "must document" insofar as products are to betransferred, i.e. taken into production or transferred to another manufacturingsite.

從GMP的角度來說，轉移計劃是否是“必須的文件”的問題已經(jīng)在大多數(shù)制藥公司的轉移SOP中得到肯定的回答。這里應該提到的是，上述轉移SOP也是一份“必須的文件”，因為產(chǎn)品將被轉移，即投入生產(chǎn)或轉移到另一個生產(chǎn)場地。

The times when products were transferred by faxing the manufacturinginstructions alone are long gone. Since the major amendment of Chapter 4 of theEU GMP Guide in 2011, the Transfer Plan as well as the Transfer SOP have beenincluded in the list of required documents. Chapter 4.29 states:

僅通過傳真生產(chǎn)說明就進行產(chǎn)品轉移的時代早已一去不復返了。自2011年對《歐盟GMP指南》第4章進行重大修訂以來，轉移計劃和轉移SOP已被列入所需文件清單。第4.29章規(guī)定：

"There shouldbe written policies, procedures, protocols, reports and the associated records ofactions taken or conclusions reached, where appropriate, for the followingexamples: [...] - Technology transfer [...]."

“對于下列例子，應酌情制定書面政策、程序、方案、報告和所采取行動或得出的結論的相關記錄：[......]- 技術轉移[...]。

"Procedure"means SOP, "protocol" stands for plan.

“程序”是指SOP，“方案”代表計劃。

As expected from aGMP Guideline, there is no indication of the level of detail. These should bedescribed in the Transfer SOP. As a rule, information on the transfer itself(which product, which sites), on the responsibilities and, if applicable, onthe regulatory strategy is expected here. Also important are details on therelease of the batches produced in the receiving site and which criteria mustbe fulfilled for the transfer process to be considered complete.

GMP指南中沒有關于此文件詳細程度的說明。應在轉移 SOP 中描述。通常，應說明有關轉移本身（什么產(chǎn)品，什么場地），責任以及監(jiān)督策略（如適用）的信息。同樣重要的內容包括，有關接受方場地生產(chǎn)的批次的放行以及必須滿足哪些標準才能將轉移過程視為完成的詳細信息。

Many otherdocuments are required or useful in a product transfer, but are not consideredGMP-required. However, they can be helpful in inspections and audits. Theseinclude, for example, project schedules, lists of documents handed over, EHSassessments, etc. However, one should not forget the documents that areessential for a transfer from a GMP perspective: change control onthe donor and receiving side.

許多其他文件在產(chǎn)品轉移中是必需的或有用的，但不被視為GMP必需的。但是，它們在檢查和審計時可能是有用的。例如，這些包括項目進度表，移交的文件清單，EHS評估等。但是，從GMP的角度來看，不應該忘記對轉移至關重要的文件：轉出方和接收方的變更控制。