Product Transfer: Is a Transfer Plana required GMP Document?

产品转移：转移计划是必需的GMP文件吗？

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

产品/技术转移中的一个常见问题是：转移计划是否是必需的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.

从GMP的角度来说，转移计划是否是“必须的文件”的问题已经在大多数制药公司的转移SOP中得到肯定的回答。这里应该提到的是，上述转移SOP也是一份“必须的文件”，因为产品将被转移，即投入生产或转移到另一个生产场地。

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:

仅通过传真生产说明就进行产品转移的时代早已一去不复返了。自2011年对《欧盟GMP指南》第4章进行重大修订以来，转移计划和转移SOP已被列入所需文件清单。第4.29章规定：

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

“对于下列例子，应酌情制定书面政策、程序、方案、报告和所采取行动或得出的结论的相关记录：[......]- 技术转移[...]。

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

“程序”是指SOP，“方案”代表计划。

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指南中没有关于此文件详细程度的说明。应在转移 SOP 中描述。通常，应说明有关转移本身（什么产品，什么场地），责任以及监督策略（如适用）的信息。同样重要的内容包括，有关接受方场地生产的批次的放行以及必须满足哪些标准才能将转移过程视为完成的详细信息。

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.

许多其他文件在产品转移中是必需的或有用的，但不被视为GMP必需的。但是，它们在检查和审计时可能是有用的。例如，这些包括项目进度表，移交的文件清单，EHS评估等。但是，从GMP的角度来看，不应该忘记对转移至关重要的文件：转出方和接收方的变更控制。