2024年4月15日发(作者：win to go 系统缺点)

Add the following:

〈1224〉 TRANSFER OF ANALYTICAL PROCEDURES

INTRODUCTION

Testing to the specification of an ancillary material, intermediate, and/or ingredient and product is critical in

establishing the quality of a finished dosage form. The transfer of analytical procedures (TAP), also

referred to as method transfer, is the documented process that qualifies a laboratory (the receiving unit)

to use an analytical test procedure that originated in another laboratory (the transferring unit), thus

ensuring that the receiving unit has the procedural knowledge and ability to perform the transferred

analytical procedure as intended.

The purpose of this general information chapter is to summarize the types of transfers that may occur,

including the possibility of waiver of any transfer, and to outline the potential components of a transfer

protocol. The chapter does not provide statistical methods and does not encompass the transfer of

microbiological or biological procedures.

引言

测试，以规范的辅助材料，中间，和/或原料和产品是在建立一个成品剂型质量的关键。分析程序的

转移（TAP），也是指方法转移，是一个文件处理程序一个合格的实验室（接收单位）去使用一个分析方法

程序源于另一个实验室（转让单位）。确保接受单位有程序性知识和能力去执行方法转移。

这一般信息章节的目的是总结这可能发生的各种转移的类型，包括任何转让的可能性，和概述潜在转

移协议组分。本章不提供的统计方法，并不包括转让微生物或生物程序。

TYPES OF TRANSFERS OF ANALYTICAL PROCEDURES

TAP can be performed and demonstrated by several approaches. The most common is comparative

testing performed on homogeneous lots of the target material from standard production batches or

samples intentionally prepared for the test (e.g., by spiking relevant accurate amounts of known

impurities into samples). Other approaches include covalidation（协同验证） between laboratories, the

complete or partial validation of the analytical procedures by the receiving unit, and the transfer waiver,

which is an appropriately justified omission of the transfer process. The tests that will be transferred, the

extent of the transfer activities, and the implementation strategy should be based on a risk analysis that

considers the previous experience and knowledge of the receiving unit, the complexity and

specifications of the product, and the procedure.

分析程序的转移类型

分析程序的转移可以有几种方法实施及论证。最常见的是同质批次标准生产批号或特意制备的样品测试（例

如，样品中加入已知杂质的准确的量）的目标材料进行比较测试。其他方法包括，在实验室之间的验证，

由接收单位进行的分析方法的完全的或部分的验证，转移减免，这是一个适当的减少转移程序繁琐的过程。

这些测试的变化，转移活性的范围，执行策略将依据风险分析，之前的经验，接收单位的认识，复杂性，

产品的规格及程序来进行。

Comparative Testing

Comparative testing requires the analysis of a predetermined number of samples of the same lot by both

the sending and the receiving units. Other approaches may be valid, e.g., if the receiving unit meets a

predetermined acceptance criterion for the recovery of an impurity in a spiked product. Such analysis is

based on a preapproved transfer protocol that stipulates the details of the procedure, the samples that

will be used, and the predetermined acceptance criteria, including acceptable variability. Meeting the

predetermined acceptance criteria is necessary to assure that the receiving unit is qualified to run the

procedure.

比较测试

比较测试要求由转移单位和接收单位分析指定数量的相同样品。其他方法也可有效，例如，如果接收

单位预先制定了验收准则可以在产品中包含已知杂质。此分析基于预先批准的转移协议所保证的程序的细

节，将用到样品，和预先制定的接收规则，包括可接受的变性。汇总可接受的接受规则是必要地以确保接

受单位有资格运行这个程序是有必要的。

Covalidation（协同验证） Between Two or More Laboratories

The laboratory that performs the validation of an analytical procedure is qualified to run the procedure.

The transferring unit can involve the receiving unit in an interlaboratory covalidation, including them as a

part of the validation team at the transferring unit and thereby obtaining data for the assessment of

reproducibility. This assessment is made using a preapproved transfer or validation protocol that

provides the details of the procedure, the samples to be used, and the predetermined acceptance

criteria. The general chapter Validation of Compendial Procedures

about which characteristics are appropriate for testing.

两个及以上的实验室的共同验证

实验室完成一个分析程序的确认后即有资格进行此程序。转移单位及接收单位可伴随进行多个实验室

验证，他们自己可包含进去作为转移单位验证团队的一部分，从而可获得重复性评价的数据。这个评价由

预先转移的或验证协议中程序的细节获得，用到了样品，及预先制定的接收标准。此通则“药典程序的验

1225 provides useful guidance