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Product Transfer: Is a Transfer Plana required GMP Document?

產(chǎn)品轉(zhuǎn)移：轉(zhuǎn)移計(jì)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(shù)轉(zhuǎn)移中的一個(gè)常見問題是：轉(zhuǎn)移計(jì)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(zhuǎn)移計(jì)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(zhuǎn)移SOP中得到肯定的回答。這里應(yīng)該提到的是，上述轉(zhuǎn)移SOP也是一份“必須的文件”，因?yàn)楫a(chǎn)品將被轉(zhuǎn)移，即投入生產(chǎn)或轉(zhuǎn)移到另一個(gè)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(jìn)行產(chǎn)品轉(zhuǎn)移的時(shí)代早已一去不復(fù)返了。自2011年對(duì)《歐盟GMP指南》第4章進(jìn)行重大修訂以來，轉(zhuǎn)移計(jì)劃和轉(zhuǎn)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(duì)于下列例子，應(yīng)酌情制定書面政策、程序、方案、報(bào)告和所采取行動(dòng)或得出的結(jié)論的相關(guān)記錄：[......]- 技術(shù)轉(zhuǎn)移[...]。

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

“程序”是指SOP，“方案”代表計(jì)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(guān)于此文件詳細(xì)程度的說明。應(yīng)在轉(zhuǎn)移 SOP 中描述。通常，應(yīng)說明有關(guān)轉(zhuǎn)移本身（什么產(chǎn)品，什么場地），責(zé)任以及監(jiān)督策略（如適用）的信息。同樣重要的內(nèi)容包括，有關(guān)接受方場地生產(chǎn)的批次的放行以及必須滿足哪些標(biāo)準(zhǔn)才能將轉(zhuǎn)移過程視為完成的詳細(xì)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(zhuǎn)移中是必需的或有用的，但不被視為GMP必需的。但是，它們?cè)跈z查和審計(jì)時(shí)可能是有用的。例如，這些包括項(xiàng)目進(jìn)度表，移交的文件清單，EHS評(píng)估等。但是，從GMP的角度來看，不應(yīng)該忘記對(duì)轉(zhuǎn)移至關(guān)重要的文件：轉(zhuǎn)出方和接收方的變更控制。