BRIEFING
1224 Transfer of Analytical Procedures. 分析方法转移
After publication of the Stimuli article “Transfer of Analytical Procedures: A Proposal for a New
General Information Chapter” in PF 35(5) [Sept.–Oct. 2009] and based on comments received, the General Chapters—Physical Analysis Expert Committee proposes this new general information chapter. The proposed chapter is intended to become one of a series of general chapters that
provides guidance for generation of data (i.e., qualification, validation, and verification) in support of compendial analytical procedures. While the concepts presented in the proposed chapter are related to the verification processes described in general chapter Verification of Compendial Procedures 1226 , the verification process is focused primarily on the drug product and associated matrix effects or other potent
ial interference issues. In contrast, the procedure-transfer process focuses on qualifying the receiving laboratory to perform an analytical procedure that was developed and validated in another laboratory.
(GCPA: H. Pappa.) Correspondence Number—C74516 分析方法转移程序的目的是为了确认接收的实验室是否可以进行在另一个实验室中研发并经过验证的检验方法。
Comment deadline: March 31, 2011
Add the following:
1224 TRANSFER OF ANALYTICAL PROCEDURES
分析方法转移程序
INTRODUCTION 前言
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, also referred to as the sending unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended.
对辅料、中间体、和/或药物成分和产品进行检验确定是否符合质量标准对确定制剂成品的质量是非常重要的。分析方法转移程序（TAP），通常也称作方法转移，该程序就是记录一个实验室（接收方）能够使用由另一个实验室（转移方，也称作转出方）所开发检验方法的过程，并确保接收的实验室知道检验的程序并有能力按规定进行检验。
The purpose of this general informational chapter is to summarize the types of transfers that may occur, including the possibility of waiver of any verification, and to outline the potential components of a transfer protocol. This chapter does not provide statistical methods and does not encompass the transfer of microbiological or biological procedures.
该节内容的目的是总结可能存在的分析方法转移的类型，包括可能不需要进行任何确认，概述转移方案中需包含的内容。该节不包括统计方法，也不包含对微生物和生物检验方法的转移。
TYPES OF TRANSFERS OF ANALYTICAL PROCEDURES分析方法转移类型
TAP can be performed and demonstrated by several approaches. The most common is comparative te
sting 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 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. In early development phases the procedure understanding may be limited. In those cases, the transfer process is more challenging because of incomplete knowledge about the variables of the procedure, particularly its robustness. This may complicate the transfer process by adding more variables to a system that should be as simple as possible.
进行分析方法转移有好几种方法。其中最常用的方法是：对从生产批次取出的同批次样品或为检验专门制备的样品（例如：将相对准确的一定量的已知杂质添加到样品中），两个实验室同时进行检验并进行对比。其他的方法包括：实验室间一起进行验证；接收方进行完整的或部分的分析方法验证；或者有充分理由证明不需进行分析方法转移。将要转移的方法，需进行的转移工作的程度以及执行的方法应根据
风险分析来进行，需考虑到之前的经验，接收方得情况、产品的复杂性和规格标准以及相应的方法等内容。在早期研发阶段，对分析方法的理解也是有限的，转移过程会更具挑战性，因为对方法中存在的变动因素认识不充
分，尤其是否方法的耐用性。因为对本应该尽可能简单的系统增加了更多的变动因素，所以使转移过程变得更复杂。
Comparative Testing 对比试验
validation verificationComparative testing is the most common method for TAP and requires the analysis of a predetermined number of samples of the same lot by both the sending and 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 acceptance criteria and comparing data generated by both parties are ways of assuring that both sending and receiving units are similarly qualified to run the procedure.
进行对比试验是分析方法转移时最常用的方法，需要转出方和接收方同时对同一批次的样品进行检验（
需要进行的检验批次数应预先规定）。其他的方法也可能是有效的，例如：对于一个掺了杂质的产品，接收方测定的杂质回收率符合预先规定的标准。所进行的分析应根据预先批准的转移方案来进行，方案中规定的程序的具体细节，应使用的样品，和预先规定的标准，包括可接受的变异性。检验结果符合标准规定并且将转出方和接收方的所得的结果进行比较，可以保证双方都能进行检验，能力相当。
Covalidation Between Two or More Laboratories 两个实验室或多个实验室间的共同验证
The laboratory that performs the validation of an analytical procedure is qualified to run the procedure. Manufacturers can involve the receiving unit in an interlaboratory covalidation, including them as a part of the validation team 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. General chapter Validation of
Compendial Procedures 1225provides useful guidance about which characteristics are appropriate for testing.
进行了分析方法验证的实验室是可以使用检验方法的。生产企业可以让接收方参与多个实验室的共同验证工作，将接收方作为验证小组的成员，因此需要进行重现性的评估并获得相关数据。该评估按照预先批准的转移或验证方案来进行，方案中规定了该程序的具体细节，应使用的样品，和预先规定的标准。通则1225“药典方法的验证”就需对哪些项目进行验证提供了非常有用的指南。
Revalidation 再验证
The revalidation or partial revalidation is another acceptable approach for transfer of a validated procedure. This approach is more time consuming than comparative testing, and manufacturers also may find it more difficult to observe bias between different sites, operators, and instruments.
进行再验证或部份验证是分析方法转移中使用的另一个可行的方法。这种方法比仅作对比试验要耗费时间，生产商更难发现不同场地、不同操作人员和不同仪器之间的偏移。
Transfer Waiver 转移豁免（不需要进行分析方法转移的情况）
The conventional TAP may be omitted under certain circumstances. In such instances, the receiving unit is considered to be qualified to use the analytical test procedures without comparison and generation of interlaboratory comparative data. The following examples give incidences that may justify the waiver of TAP:
在某些特定的情况下，不需要进行常规的分析方法转移。在这种情况下，不需要进行对比，也不需要获得实验室间的对比数据，就可认为接收方是有资格进行分析方法的。下面的情况不需要进行方法转移。
The new product’s composition is comparable to that of an existing product and/or the concentration of active ingredient is similar to that of an existing product and is analyzed by procedures with which the receiving unit already has experience.
新产品的成份与已有的品种的成份类似和/或活物的浓度与已有产品的浓度类似，并且对于使用的分析方法，接收方有经验。
•The analytical procedure is the same or very similar to a procedure already in use.
检验方法与已使用的方法相同或非常相近。
•The personnel in charge of the development, validation, or routine analysis of the product at the sending unit are moved to the receiving unit.
负责方法开发、验证或产品日常检验的人员有转出方调到接收方。
ELEMENTS RECOMMENDED FOR THE TRANSFER OF ANAYTICAL PROCEDURES
进行分析方法转移建议需考虑的因素
Several elements, many of which are interrelated, are recommended for a successful TAP using the
comparative testing approach. When appropriate and as a part of pre-transfer activities, the sending unit should provide training to the receiving unit, or the receiving unit should run the procedures and identify any issues that may need to be resolved before the transfer protocol is signed. Training should be documented.
在使用对比检验来进行成功的方法转移时，建议应考虑到一些因素（其中很多内容是相互关联的）。作为方法转移前的准备活动，转出方应对接收方进行培训或者在转移方案签字前，接收方应使用一下将转移的方法并确认存在哪些问题。进行的培训应记录。
The transferring unit, often the development unit, is responsible for providing the analytical procedure, the reference standards, the validation reports, and any necessary documents, as well as for providing the necessary training and assistance to the receiving unit as needed during the transfer. The receiving unit may be a quality control unit, another intracompany facility, another company, or a contract research organization. The receiving unit provides qualified staff or properly trains the staff before the transfer, ensures that the facilities and instrumentation are properly calibrated and qualified
as needed, and verifies that the laboratory systems are in compliance with applicable regulations and in-house general laboratory procedures. Both the transferring and receiving units should compare and discuss data as well as any deviations from the protocol. This discussion addresses any necessary corrections or updates to the final report and the analytical procedure as necessary to reproduce the procedure.
转出方，通常是研发部门，负责提供分析方法，对照品，验证报告，必要的文件，并且须提供必要的培训，在方法转移的过程中给予接收方必要的帮助。接收方可能是质量控制部门、公司内部的其他部门、其他公司或委托研发机构。在方法转移前，接收方应确保具有适当资质的人员或在方法转移前对人员进行适当的培训，确保设施也仪器都根据需要进行合适的饿校正和确认，并确定实验室的体系是符合相应法规和内部的实验室管理程序要求的。转出方和接收方都应对数据进行比较并讨论，包括与方案发生的偏差。经讨论决定对最终的报告和检验方法需要进行哪些更改或更新，这些内容对重新起草检验方法是必要的。
A single lot of the article may be used for the transfer because the aim of the transfer is not related to the manufacturing process but rather to the evaluation of the analytical procedure’s performance at the receiving site. If two or more different lots are used, the lot-to-lot variability should not be computed.
对于方法转移可能选择一个批次，因为方法转移的目的与生产工艺无关，而是为了评估检验方法在接收方是否可行。如果选择两个批次或更多的批次的话，不需计算批与批间的差异。
PREAPPROVED PROTOCOL预先批准的方案
A well-designed protocol should be discussed, agreed upon, and documented before the implementation
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